PLEASE read...

Please read through this blog before you consider this injection--SYNVISC. If you have already suffered with an adverse reaction, read through posts and comments to find out how I was able to regain my health and get my life back. It took years, but I am doing so much better! I check this blog periodically, but not regularly now... PLEASE leave a comment so that others know your experience!!! If I can help ONE person avoid the hell I suffered, then this blog is time well spent!

My Symptoms following Synvisc

I'm 3 years out from my Synvisc injections after my OS suggested this about 2 months following arthroscopic knee surgery after an injury. I had a life-threatening adverse event/reaction to Synvisc. Most of the symptoms lasted WELL over a year, and I still deal with some. IV chelation & IV nutrition therapies, as well as specific homeopathics SAVED MY LIFE and have helped to restore my health. I still deal with some of these symptoms, especially if I go too long without chelation. I've come a long way since this first started, but it's been a LONG, HARD-fought battle to get to where I am today. And EXPENSIVE. Consider this BEFORE you consent to Synvisc injections for knee pain or when your OS suggests that you're a good candidate for these injections. You're likely a better candidate for Ozone injections that actually heals the joint and prevents knee-replacement! [I am not a doctor and nor do I profit off of ozone treatments. Just a person who went through hell physically and emotionally following Synvisc injections.]

Is it worth years of this:

a] debilitating fatigue
b] periods of breathing difficulties
c] racing heart and cough
d] Sticky skin & sticky inside of my mouth
e] loss of coordination and balance, and some short term memory
f] Dizzy spells/passing out
g] persistent tremors throughout face, chest and arms
h] brain tremors -- feels like the vibration of an idling car
i] Intense acid burning that started with the knee injection, and burned down through the lower leg.
j] The intense burning then moved throughout my body and entire nervous system, including my brain. It was unbearable in the first several months
k] Random body jerks and pressure in my chest that started with the injection.
l] Numb arms, hands, legs, feet
m] Body trembled uncontrollably
n] OVER THE TOP chemically sensitive since injections
o] I had extreme tightness behind the knee for weeks, Baker's Cyst was ruled out

fda adverse event/ side effects reports - 10

Two doctors that I saw in regards to my life-threatening adverse event DISCREDITED the FDA MAUDE reports because they are "often sent in by the patient." One said that he petitioned the FDA to stop posting such reports unless the physician submitted them. When most physicians who administer Synvisc are in denial of causation, the public would NEVER learn the truth. And WHY do doctors believe that patients do not know their own bodies, and can file such reports?

Here are more reports to the FDA MAUDE database.
****


Event Date 01/06/2010
Event Type Injury Patient Outcome Other;
Event Description
I received synvisc injections in both knees on (b)(6)2010, (b)(6)2010 and (b)(6)2010. A few days after the 1st injection, i noticed "pins + needles" and burning sensation on my arms and back, neck + legs. The same dr prescribed prednisone + zyrtec (no relief). I then saw a dermatologist who prescribed a 28 day regimen of prednisone. The condition was relieved but when i stopped the prednisone the condition came right back. It is now almost 9 months after the 1st injection of synvisc and i still have the same uncomfortable painful condition. Dates of use: (b)(6)2010, (b)(6)2010, (b)(6)2010. Diagnosis or reason for use: osteoarthritis. Event abated after use: no.

*****

Event Date 02/09/2010
Event Type Injury Patient Outcome Required Intervention; Other
Event Description
Letter written 04/05/2010. On (b) (6) 2010, dr. (b) (6) gave me a referral to see dr. (b) (6) at the orthopedic and fracture clinic, (b) (6), to receive possible cortisone shots in both my left and right knees. Dr. (b) (6) was not available so the clinic had me see dr. (b) (6) at the same location. My initial office visit was (b) (6) 2010 with dr. (b) (6). They took x-rays and dr. (b) (6) told me that there was something much better and more effective than cortisone shots called synvisc one and that if i was not allergic to chicken, eggs or any such products that i was a perfect candidate for these injections. My first injection was on (b) (6) 2010, in my right knee. The left knee synvisc one injection was done on (b) (6) 2010. In less than two days, i had terrible pain. My knees were very swollen; i couldn't even walk nor go to work. When i went to my first consultation appointment with dr. (b) (6), i walked in wearing high healed wedged boots and only wanted a cortisone shot. He said he wouldn't give me cortisone shots unless i was going on a trip. The choices he gave me were to either opt for the synvisc one injections or knee replacement surgery. I do not need knee replacement, so i trusted dr. (b) (6) and with his advice chose the synvisc one injections. He said that the affects of these injections were much better than cortisone shots & would last for six months to two years, i was so excited! by (b) (6) 2010, i was so swollen that he had to drain 30 cc of fluid from my right knee and 15 cc of fluid from my left knee. Dr. (b) (6) said they had to culture the fluid to see if i had any infection and to not eat after midnight in case i had to go into the hospital the next morning for emergency surgery. I heard back from (b) (6) his assistant friday morning that i had no infection. Since (b) (6) 2010, i have been walking with a cane and have not been able to drive - my husband has to drive me wherever i go. I also have not been able to work since i had the injections. On (b) (6) 2010, i saw dr. (b) (6) and he admitted at that time that i was the third person as this clinic to have an allergic reaction to synvisc one at their clinic after seeing me & the negative results it had on me. In my opinion, they should not have given these shots to anyone after the first allergic reaction. That same day, he drained fluid from both legs and cultured it again to make sure there were no "bugs" growing, as he put it to me. Also, at 5 pm, that same day, they ordered an appointment for me to go to (b) (6) hospital for an ultrasound on my left leg to rule out any possibility of a blood clot. The results were negative. Thank goodness. On (b) (6) 2010, at 3 pm, i saw dr. (b) (6). He advised me to have knee replacement surgery a. S. A. P. I was walking fine on my first visit on (b) (6) 2010, in high heeled wedge boots. I do not need knee replacement! therefore on (b) (6) 2010, i asked dr. (b) (6), "how long will it take or how does synvisc one leave my body?" no one had an answer for me. That is when i asked if i could have cortisone shots in my knees so that i could have some relief from the pain & affects from the synvisc one shots. After two hours, they finally agreed to give me the cortisone shots, yet very reluctantly. Today, i am still walking with a cane, not working, and my body shakes from these synvisc one injection shots. None of these symptoms did i have prior to receiving these injections. This is totally inexcusable! i feel like i have two broken knee caps. I reported this to synvisc one at their phone number (b) (4) and at www. Synvisc. Com. I have yet to receive a call back from them! i also reported this to the fda to (b) (4). My fda consumer complaint (b) (4). This product in my opinion should not be on the market at all. And how is someone going to fix my problem? the side affects and reactions my body has are from nothing other than the synvisc one injection shots at this clinic. The fda must investigate this synvisc one on my behalf and provide me with all info such as how many pts were injected with synvisc one and the condition of all these pts. I deserve to know what kind of permanent damage was done to me and my body by these synvisc one injection shots. Frequency: injection- each knee. Dates of use: (b) (6) 2010; (b) (6) 2010. Event abated after use, stopped or dose reduced: no.

****

Event Date 07/01/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Felt funny [feeling abnormal]. Disoriented [disorientation], right leg pain [pain in extremity], respiratory problems [respiratory disorder]. Right leg swelled up [oedema peripheral]. Case description: a spontaneous report was received on 14-mar-2010 and 16-mar-2010 from a (b) (6) male pt with a history of osteoarthritis of the knee, (b) (6), who experienced feeling funny, right leg swelling, right leg pain, disorientation and respiratory problems after treatment with synvisc. The pt had no history of previous treatment with synvisc. On unspecified dates in (b) (6) 2009, he received treatment with synvisc in the right knee. Soon after getting synvisc, the pt felt funny and disoriented. He also experienced right leg pain and swelling. The disorientation worsened and four days after the onset of symptoms, he was transported to the hosp by ambulance. The pt reported that he spent four days in the intensive care unit where he experienced respiratory problems. At the time of this report, the outcome of the pt was unk. Mfr's comment: the benefit-risk relationship of synvisc is not affected by this report.

****
Event Date 02/01/2010
Event Type Injury
Event Description
Complainant has osteoarthritis. She had been receiving cortisone shots every 4-6 months for the last 1 1/2 years with no problems. Her primary care doctor convinced her that the new synvisc one would be the best thing for her, so she agreed to the shots. On (b) (6) 2010, she received an injection of synvisc one in her right knee. On (b) (6) 2010, she received an injection of the same in her left knee. Approx 2 1/2 weeks later on (b) (6) 2010, her legs swelled up and she was in excruciating pain. She was seen by her primary care doctor who withdrew 30 cc of fluid from her right leg and 15 cc of fluid from her left leg. These were later cultured and found to have no infection. She was rushed to (b) (6) hospital, (b) (6) where she had an ultrasound and they determined that she did not have any blood clots. She is not allergic to eggs or poultry products. She is so upset because the doctor admitted to her in the presence of her husband that she was the third person this month at this clinic to have a reaction. She was previously very active and athletic and now can hardly walk. She lays down at 5:00 pm each day and doesn't' get up until noon the following day because she feels so terrible. This severely limits her mobility and affects her employment as well as she is self-employed and cannot get to work. She contacted the company and was told to contact the mfr which is the genzyme corp.

****

Event Date 08/01/2010
Event Type Injury Patient Outcome Hospitalization;
Event Description
Increased blood pressure [blood pressure increased]. Flushed in the face [flushing]. Felt dizzy [dizziness]. Headache [headache]. Case description: a spontaneous report was received on august 16, 2010 from a (b)(6) female patient with a history of osteoarthritis, (b)(6), who experienced blood pressure had risen to 168/90, felt flushed in the face, felt dizzy, and headache after treatment with synvisc. The patient had no history of previous treatment with synvisc. On (b)(6) 2010, the patient received an injection of synvisc into her left knee. On (b)(6) 2010, one day after the injection, the patient reported that she felt flushed in the face and dizzy for about 10 seconds. On (b)(6) 2010, the patient received her second synvisc injections. Two days later on (b)(6) 2010, the patient felt dizzy again, "like i was having a stroke" for about 3-4 minutes. She went to the emergency room where she reported her blood pressure had risen to 168/90. She was admitted overnight for testing. Treatment included starting an unspecified blood pressure medication. Mri and ct scans were both negative. Her blood pressure returned to normal, and the patient was discharged on (b)(6) 2010. On (b)(6) 2010, the patient complained of an ongoing headache. She reported that she is following up with her physician and plans to have her third synvisc injection. Manufacturer's comment: the benefit risk relationship of synvisc is not affected by this report.

****

Event Date 06/03/2010
Event Type Injury Patient Outcome Hospitalization;
Event Description
Cellulitis of the right leg [cellulitis]; vomiting [vomiting]; right knee redness 3 inches below the right kneecap [erythema]; fever [pyrexia]; nausea [nausea]; right knee swelling [joint swelling]; right knee pain [arthralgia]. Case description: spontaneous report received on 06/07/10 from a (b)(6) female pt, (b)(6), with a relevant medical history of osteoarthritis of both knees and previous synvisc injections about five years ago. The pt received the synvisc-one injection into each knee on (b)(6) 2010. The synvisc-one lot number was unk. On the morning of (b)(6) 2010, the pt woke up with right knee pain, right knee swelling, and right knee redness 3 inches below the right kneecap. The pt also complained of flu-like symptoms including: nausea, vomiting, and fever. Starting on 06/03/10, the pt was hospitalized for the events. The pt was diagnosed with cellulitis of the right leg and treated with keflex and clindamycin. The pt was discharged from the hospital on (b)(6) 2010, at which time the right leg cellulitis was improving. No further info was provided. As of the date of receipt of this report, the pt outcome was unk.

*****

Event Date 04/18/2010
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
H. Influenzae septic arthritis [septic arthritis haemophilus]. Unable to bear weight [weight bearing difficulty]. Knee hot [joint warmth]. Pain in the left knee [arthralgia]. Knee swollen [joint swelling]. Knee effusion [joint effusion]. Elevated liver enzymes [hepatic enzyme increased]. Case description: regulator-spontaneous report (b)(4) received on 01-jun-2010 from a pharmacist regarding a pt whose initials, age and gender were not provided. The pt had a history of osteoarthritis and pain. The pt received synvisc-one injections in both knees. The lot number of synvisc-one used was not provided. Two days later on (b)(6)-2010, the pt reported to the emergency room complaining of severe pain in the left knee only. The pt was unable to bear weight. The knee was also hot and swollen. Aspiration of the knee revealed h. Influenzae on culture. The pt was admitted to the hospital once the culture results were available. After i&d, the tp was started on intravenous (iv) antibiotics for septic arthritis which included ceftriaxone 2gm every day. It was reported that the pt had elevated liver enzymes. As of the date of receipt of this report, the pt's outcome was unk. Mfr's comment: the benefit-risk relationship of synvisc one is not affected by this report.

****

Event Date 03/01/2010
Event Type No Answer Provided Patient Outcome Other;
Event Description
Right leg pain [pain in extremity], difficulty walking [gait disturbance], baker's cyst felt tighter [synovial cyst], knee pain [arthralgia], leg/knee pain back [device ineffective]. Case description: an spontaneous report was received on 02-jun-2010 from a (b)(6), female, patient, with a history of osteoarthritis of the right knee, (b)(6), who experienced intense right leg and knee pain, difficulty walking, her baker's cyst felt tighter, and her right knee pain was back to where it was, before she received the synvisc-one. The patient received an injection of synvisc-one in the right knee in (b)(6) of 2010. The patient reported that after about three days of receiving the synvisc-one injection, she experienced intense right leg/knee pain. The patient also had difficulty walking and complained that the baker's cyst on the back of her right knee felt tighter. According to the patient, she was treated with a dose-pack of prednisone which alleviated her right leg pain. The patient stated that now her leg/knee pain is back to where it was, before she received the synvisc-one injection. At the time of this report, the outcome of the patient was unknown. Manufacturer's comment: the benefit-risk relationship of synvisc one is not affected by this report.


****
Lot Number U0912
Event Date 01/20/2010
Event Type No Answer Provided Patient Outcome Other;
Event Description
Knees were red [erythema]. Knees were hot [joint warmth]. Fever [pyrexia]. Knee pain [arthralgia]. Knee effusion [joint effusion]. Knees were swollen [joint swelling]. Normal gait was not possible/needed crutches for walking [gait disturbance]. Case description: a spontaneous report was received on 10-may-2010 from an hcp regarding a (b)(6) male pt with a history of gonarthrosis of the knee (of degenerative etiology), (b)(6), who experienced fever, knees were hot, red and swollen, normal gail was not possible, needed crutches for walking, and knee pain and effusion after starting synvisc. On (b)(6) 2010, an initial report was received from the pt's hcp. The hcp reported that the pt had a history of advanced bilateral gonarthrosis, and prosthesis placement was contra-indicated in the pt. According to the hcp, the pt was treated in both the knees with synvisc. There was no incident after the first set of injections in both the knees. After the second set of injections in both knees, in less than 24 hours, the pt experienced knee pain and effusion. Syringes from two different lots were used for the first and second set of injections. The hcp stated that he planned to switch to euflexxa for the next treatment. On 10-may-2010, additional info was received from the hcp wherein the hcp elaborated on the pt's medical history. He added that the pt had a right meniscus removal in 1970; had surgery for carpal tunnel syndrome (cts) in 2005, and also has benign prostate hyperplasia (bph). The hcp also stated that the pt has had previous treatment with synvisc in the past; 2004, synvisc in the right knee; 2008, synvisc in both knees; 2009, synvisc in both knees. In all these instances there was "no incident" with the usage of synvisc. He also stated that the pt had gonarthrosis of degenerative etiology. The concomitant medications the pt was on were dutasteride for (bph) and chondrosulf (for osteoarthritis). In the 2010 synvisc series, the pt was injected with synvisc on (b)(6) 2010 and (b)(6) 2010 in both knees. No arthrocentesis was performed prior to the synvisc injections. A green, 21 gauge syringe was used for each injection and the synvisc was at room temperature when injected. The syringes used in the first and second set of injections were from a different lot. The lot number for the first set of injections is not known. The syringes used for the second set of injections are from lot number u0912. According to the hcp, in less than 24 hours following the second injection, the pt experienced pain and effusion. The pt also experienced fever, his knees were swollen, hot and red. Normal gait was not possible and the pt needed crutches to walk. Clinical signs were mimicking septic arthritis or hyperuricemic arthritis. The c-reactive protein was elevated at 182 mg/l and the eosinophil sedimentation rate was at "45/84 mm western green. " the pt was treated with icepack and rest. On 12-may-2010, additional info was received in the form of qa results. The production and quality control documentation for lot #u0912, with expiration date, 07/2012 was reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted. On 17-may-2010, additional info was received from the hcp wherein the hcp clarified that this was not a case of septic arthritis or hyperuricaemic arthritis. The hcp stated that the clinical symptoms initially led to the suspicion but the pt quickly recovered without any sequelae. In the opinion of the hcp, the adverse events experienced by the pt were of severe intensity and were definitely related to the use of synvisc. At the time of this report, the pt has recovered without sequelae from all the adverse events. The onset date for the event was (b)(6) 2010 and the offset date was (b)(6) 2010.

****

Event Type No Answer Provided Patient Outcome Required Intervention;
Event Description
Extreme pain [arthralgia]. Swelling [joint swelling]. Benign tumor in the back of left knee [benign neoplasm]. Ruptured baker's cyst right knee [synovial rupture]. Osteoarthritis in right knee [osteoarthritis]. Case description: a spontaneous report received on 16-apr-2010 from a (b)(6) female pt, (b)(6), with a medical history of left knee pain and right knee anterior cruciate ligament (acl) replacement in 2006. The pt received the synvisc series into the left knee on unk dates in 2007. On an unk date, a benign tumor was discovered in the back of her left knee which was removed on an unk date. In addition, on an unk date she experienced extreme pain, swelling, and was diagnosed with left knee synovitis. On an unk date in (b)(6) 2010, the pt experienced a ruptured baker's cyst in her right knee. The pt has left knee replacement surgery scheduled for (b)(6) 2010. The outcome of the event of benign tumor was resolved. No lot number was provided. No further info provided. (b)(4). Mfr's comment: the benefit-risk relationship of synvisc is not affected by this report

****

Event Date 01/06/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
Patient has been receiving three-dose synvisc for more than a decade without incident. But one day after her first dose of synvisc one -- a new single-dose version -- her mobility has been drastically reduced, the pain pretty much limiting her to bed. Her condition has remained this way for nearly a month. One night, the middle finger of one hand became swollen, sore and hot to the touch. The curvature of her spine has also gotten worse. Dose or amount: don't know any of because i neither doctor nor patient.

****

Denial of Causation

If your adverse event isn't isolated to the knee or fall into a typical immulogical response, expect "Denial of causation" from those administering Synvisc to be your biggest hinderance to finding the medical help you need.

Something to keep in mind.

"Chemicals Threaten Our Bodies"...says the President's Cancer Panel

This landmark report is welcomed. Since many prescriptions drugs are "chemical based," I FULLY expect the forces/money behind them to fight to keep the link drawn between the two. But I say, wake up AMERICA, you are being poisoned by the very institutes charged with keeping your best interest in mind, and placing the patient first.

Consider that Synvisc alone has two highly toxic chemicals, Formaldehyde and Divinyl Sulfone discussed extensively on this blog. And this passed the FDA approval. As someone whose health was destroyed from the moment this product was injected into my body, this landmark 240 page report released on May 6, 2010 warns that "our lackadaisical approach to regulation may have far-reaching consequences for our health."

To read further, go to http://www.nytimes.com/2010/05/06/opinion/06kristof.html to read the New York Post Op Ed New Alarm Bells About Chemicals and Cancer .

The read the President's Cancer Panel's actual report, go to this link:

http://deainfo.nci.nih.gov/advisory/pcp/pcp08-09rpt/PCP_Report_08-09_508.pdf

"The Panel urges you most strongly to use the power of your office to remove the carcinogens and other toxins from our food, water, and air that needlessly increase health care costs, cripple our Nation’s productivity, and devastate American lives."

I would add...pharmacueticals and GMO food.

The truth is, this is NOT NEW. The naturopathic community has been screaming about chemicals and the damage they cause to the human body for years. But I'm thankful that this is hitting the mainstream news FROM the mainstream medical community!

Happy New Year

I'm approaching the 2 year mark since my life was jeopardized by a series of Synvisc injections. If ALL of the information to make a true "informed consent" had been mandated by the FDA then my life would have been far healthier and more productive during this time. Every human being considering Synvisc should be aware that permissible levels of formaldehyde
[a known neurotoxin and carcinogen with a Health Rating: 3 - Severe (Poison)and cannot be made nonpoisonous] and Divinyl Sulfone
[the blistering agent of mustard gas] are allowed and not disclosed.


This injection poisoned me and burned through my entire nervous system. As it stands, I've come a long way thanks to the incredible dedication and extensive IV and detox treatments from my NMD. He has never wavered in seeing me through this ordeal. But I am still plagued with brain tremors and debilitating fatigue since these injection. And I am not alone. Many others have suffered and were blatantly dismissed by their injecting physicians as well.

It's a sad state of health affairs when pharmaceutical companies are so powerful that the welfare and lives of individuals mean absolutely NOTHING. On Feb 20, 2008 the US Supreme court voted 8:1
to protect the manufacturers of medical devices from ANY liability if the FDA deems the device "safe". Yet Synvisc and other viscosupplementations break 2 of the 4 criteria for Medical Device classification. 1) it metabolizes and 2) it causes a chemical change. This classification also means that the metabolic by-product is NOT KNOWN. This classification allows Synvisc on the market without a REMEDY when it goes systemic and causes problems like poisoning and pharma injury. How does this happen? MONEY...follow the money.

Read through the extensive information on this blog BEFORE you consent. The least I can do is warn others so they don't SUFFER hardships like too many of us have. I wish someone would've INFORMED me.

FDA Adverse Event/Side-Effect Reports -- 9

Lot Number Y0806
Event Date 09/29/2009
Event Type Injury Patient Outcome Life Threatening;
Event Description
Acute circulatory dysfunction [shock], circulatory dystonia [dystonia], hypotony [hypotonia], slight tachycardia [tachycardia]. Case description: spontaneous report received in 2009 from physician regarding a female patient with medical history gonarthrosis. The patient received her first injection of synvisc the month prior, administered via intra-articular route at a dose of 2 ml. The same day, the patient presented at the physician for injection of synvisc in the left knee. Injection was carried out slowly with sterile precautions after disinfection, using sterile gloves and breathing mask. Aspiration of bloody aspirate was noted when turning the injection needle 180 degrees after an unremarkable puncture of the left knee. Subsequent to the injection, the mobility of the knee was free. Approximately 5 minutes after the synvisc injection, the patient experienced acute circulatory dysfunction, hypotony and circulatory dystonia. The patient did not loose consciousness and was oriented to time and place during the events. The patient was placed in a shock position and 100mg prednisolone was administered after providing an access point and preceding oxygen application at 98-99% o2-saturation of the blood. The patient received 500 ml ringer's lactate intravenously, and additional oral glucose and fluid. At an unknown time relative to the events, vital signs were noted to range as follows from the time of 9:12 am to 9:54 am: bp 110/90 to 120/90 mmhg; pulse 68-86 bpm; o2 saturation 98-100%. Within 10 minutes, the patient reached the state of well being. The skin and pupil conditions were back to normal and the slight tachycardia (up to 88 beats per minute) reverted back to a normal results (72-78 beats per minute) after 15 minutes. The physician assessed the event as moderate in intensity and definitely related to the use of synvisc. The product was temporarily interrupted. The patient had recovered the following day. Manufacturer's comment: the benefit-risk relationship of synvisc is not affected by this report.


***

Event Date 03/31/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Injection site hematoma [injection site haematoma]. Thrombosis of the vena femoralis left side [thrombosis]. Case description: spontaneous report received on 24-aug-2009 from a healthcare professional regarding a male patient with osteoarthritis, with unknown medical history. The patient received his first does of synvisc administered once via intra-articular route on an unspecified date at a dose of 2 ml. Five days after starting synvisc, the patient experienced haematoma at the site of the synvisc injection. The patient was later diagnosed with deep vein thrombosis. Both events were described by the hcp as moderate in intensity and non-serious. The patient recovered without sequelae afterwards. The hcp assessed the relationship between the events and synvisc as possible. On september 23, 2009, the investigation summary was received. The product lot number was not provided; therefore, a batch record review is not possible. It is the requirement to review all finished batch records for specification conformance prior to release. Any specification result is identified and mitigated. Data is periodically presented and reviewed by individuals responsible for assuring product quality. This review has not indicated trends that could be associated with any product complaint. Genzyme will continue to monitor complaints. Follow up information was received on october 6th from the physician regarding a male patient. The patient's medical history includes coxarthrosis. In 2009, the patient received the first and the second synvisc injection administrated via intra-articular route at a dose of 2 ml one week apart. Five days after the last synvisc injection, he experienced hematoma groin left and thrombosis of the left vena femoralis which required 8 days of hospitalization. The third synvisc injection was temporarily interrupted a week later. No recanalization of the distal vena femoralis was noticed 9 months after the event. As of the date of receipt of this report, the patient recovered with sequelae, the physician reported that he might have possible post thrombosis syndrome. The hcp assessed the intensity of the reported events as severe and possibly related to synvisc treatment. The initial report indicated that the synvisc injections were performed to the hip. Manufacturer's comment: the benefit-risk relationship of synvisc is not affected by this report.

***

Lot Number P0902
Event Date 09/18/2009
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Evaluation summary: the production and quality control documentation for lot number p0902, expiry date 10/2011 were reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted.


Event Description
Fluid build-up in left knee [joint effusion]. Swelling in left knee and ankle [joint swelling]. Pain and tenderness in left knee [arthralgia]. Swelling in left foot [oedema peripheral]. Case description: spontaneous report received on 30-sep-2009 from a physician via a company representative, as well as from the consumer, regarding a female pt, whose relevant medical history included: osteoarthritis, knee pain, and previous treatment with supartz followed by knee pain. The pt received a series of synvisc injections, lot number p0902 with expiration date oct-2011, into the left knee with injections received three times within two months in 2009. The pt did not have any problems following the first and second injections. Following the third injection, the pt experienced severe left knee pain and tenderness, severe left knee swelling, and fluid build-up in the left knee. On the following day, the pt went to the emergency room where 80 cc of "yellowish" fluid was withdrawn from the left knee. According to the pt, the physicians in the emergency room did not think that she had an infection in the left knee, so no antibiotics were prescribed. The pt also started to experience some swelling in her left ankle and foot. As of the date of the report, eleven days later, the pt's symptoms in the left knee, ankle, and foot were a little better, but she was still experiencing significant pain, tenderness, and swelling in the left knee as well as swelling in the left ankle and foot. The swelling in the left knee was especially noticeable above the left knee cap. As of the date of receipt of this report, the pt outcome was not yet recovered. The qa (quality assurance) investigation results were received on 07-oct-2009. The production and quality control documentation for lot number p0902, expiry date 10/2011 were reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted. Mfr's comment: the benefit-risk relationship of synvisc is not affected by this report.

***

Event Date 09/11/2009
Event Type Injury Patient Outcome Other;
Event Description
Swelling in right and left knees and feet, also extreme pain in legs with a fever of 103. Md will not be injecting next scheduled injections for this pt due to side effects. Dose or amount: 2ml, frequency: weekly x3 weeks, route: intra-articular. Dates of use: 2005 - 2009. Diagnosis or reason for use: osteoarthritis.

FDA Adverse Event and Side Effect Reports--8

The FDA now shows the actual event descriptions / side-effects that a patient or physician sends into them for Aug and Sept '09 and blocks of random date segments. This blog wonders why there is an inconsistency in these database reports? I will continue to keep an eye on this and report what is found.

Here are some reports to the FDA for side-effects/adverse reactions to Synvisc / Synvisc One Read and make an informed consent.:


Event Date 04/01/2003
Event Type Injury Patient Outcome Required Intervention;
Event Description
Nerve inflammation. Information was received on 30 and 31-jul-2003 from a patient, with a history of osteoarthritis, depression and sleep problems. The patient reported they had no known allergies to chicken parts or proteins. The patient received three injections of their first series of synvisc to both knees in 2003. The patient experienced an itching sensation from above the knees, up to and including their private areas and a constant burning feeling that pt described as the skin feeling numb and dead and sharp needles going into their legs and into their private area. The patient also experienced painful sexual intercourse. The patient was referred to a neurologist who conducted nerve analysis and needle tests, which showed that they had nerve inflammation. The patient stated that the physician told pt the nerve inflammation must be due to the synsvic because of the timing, but he was stumped as to why synvisc would cause this. The patient treated the symptoms with benadryl cream, which had no response, and gold bond, which provided some relief. The patient has also taken steroids (type and dose regimen unknown) to help with the burning. 2 months later, the patient was prescribed neurontin (300mg bid), prednisone (10mg bid) and tylox (every four hours). The patient reported that none of the medications helped. 29 days later, the patient consulted their family physician for treatment. The prednisone and tylox were continued, and the neurontin dose was increased (600mg bid). The patient also received duragesic patches (25mg apply every 3 days, for 2 weeks). The new medication regimen did not help. At the time of this report, the patient has not yet recovered. Qa evaluation results: the review of synvisc product release data did not indicate trends that could be associated to any product complaints.


***
Event Date 08/04/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Difficulty breathing [dyspnoea], increased blood pressure [blood pressure increased], fainted [syncope], felt like she might faint when standing up [presyncope], lip swelling [lip swelling], chills [chills], dizziness [dizziness], facial rash [rash], hives [urticaria]. Case description: spontaneous report received in 2009 from a female pt whose relevant medical history included: osteoarthritis. The pt received a single injection of synvisc-one into her left knee two days prior. Within 5 to 10 minutes or receiving the synvisc-one injection, she experienced chills, facial rash, hives, dizziness, lip swelling, increased blood pressure, difficulty breathing, and she also fainted. Paramedics were called and took the pt to the hospital, and the pt was admitted that same afternoon. She was treated with saline infusion, antihistamine, and an unk parenteral medication for the treatment of high blood pressure. The pt stated that she might have received another unk medication as treatment. All of her adverse events have improved and the pt has only fainted the single time in the doctor's office. However, the pt reported still feeling like she might faint when she stands up. No further info was provided. As of the date of receipt of this report, the overall pt's outcome was unk.

***
SYNVISC

Patient Outcome Hospitalization;
Event Description
Had first synvisc injection into left knee approximately 2:00 p. M. In 2008, in orthopedic surgeon's office by the surgeon. Am status/post left knee arthroscopy in approx four months earlier. Had synvisc at suggestion of physical therapist for ongoing pain issues. I am not allergic to poultry protein, eggs or feathers. Had injection in what i would deem a sterile manner. About 3-4 minutes after injection felt mild tightness in my throat. I was still in physician's office and should have said something but because i was counseled before injection by surgeon that there were no allergic side effects unless i was allergic to poultry protein, feathers or eggs, which i am not and so i had not risk. I honestly was not sure why my throat felt a little tight, but it was mild and i felt i would be ok, not to mention the surgeon said, it was free from side effects except for those previously mentioned. I walked from doctor's office to car and while awaiting my turn to pay my parking fee, felt increased tightness in throat, had some airway difficulty and felt some tightness in upper chest, just below my throat. This was now about 15 minutes after injection. Got out of line and went back to hosp. Made it to the lobby of the physician's office and was awaiting the elevator but by now was having more difficulty getting a deep breath. A passing physician saw me in respiratory distress, got me a wheelchair and called my surgeon who said it to go to er, and i was wheeled to er. Had albuterol nebulizer treatment, iv push benadryl, and iv mini bag decadron. Over the course of about 90 minutes, i felt relief of airway constriction and chest tightness was relieved in full. I was discharged home in about 3 hours time. Emergency room physician called my surgeon who told him it was "impossible i had an allergic reaction because that just doesn't happen unless i was allergic to poultry proteins, eggs or feathers. " emergency room physician told me i indeed did have an allergic reaction and i am a nurse and am allergic to compazine and recognized the same symptoms when i took that medication some years ago being similar to how i felt after the synvisc injection, just less pronounced, a few minutes after i had the first synvisc injection. Have canceled the other two injections. Am disappointed my orthopaedic surgeon is taking this in such a cavalier manner. Being a nurse involved in research for the county department of health, i wanted to follow-up. I found several sites on an internet search identifying infrequent but known respiratory reactions to synvisc injections. I am therefore, following through to the fda in the hopes this report will perhaps enhance the drug warnings and hopefully help another potential pt. Frequency: once, route: im. Dates of use: 2008. Diagnosis or reason for use: left knee pain status/post, left knee arthroscopy. Event abated after use stopped or dose reduced? yes.

***

Lot Number UNKNOWN
Event Date 09/13/2009
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Bilateral knee synovitis [synovitis] soreness in one knee after first injection [arthralgia]. Case description: spontaneous report received in 2009 from a physician regarding a female patient, whose relevant medical history included: osteoarthritis. The patient received her first injection of synvisc into both knees in 2009, after which she experienced a "bit" of pain (soreness) in one knee. The synvisc lot number was not available. The patient received her second synvisc injection into both knees five days later, from which she experienced no problems. The patient received the third synvisc injection into both knees the following month. Starting three days later, the patient experienced some stiffness in both knees. She informed the physician that she probably "overdid things" and was "overly active". The following day, the patient started having more pain in her knees along with the swelling and numbness in her leg from the knees down. The patient stated that she could not feel anything from the knees down, resulting in the inability to walk. The next day, she went to her family physician complaining of the inability to walk. In the same month, the numbness from the knees down and the inability to walk was ongoing. Additional information was received from the physician on 22-sep-2009. The patient was seen in the er (emergency room) a week prior with the complaint of the inability to walk, from which the emergency room note was provided. The patient could not feel her legs from her knees down and could not move her legs. She had only pain localized to her knees. She was able to flex her right toes slightly plantar flexed, but that was the only movement she would give. She again stated that she had no feeling from the knees down. She would not straighten her knees at first, but following encouragement from the physician, she was able to fully extend her knees. She did have bilateral knee effusions. She had a good dorsalis pedis and posterior tibial pulse in both feet. She also had a good capillary refill. After sterile prep and anesthesia of the right knee, the knee was aspirated of 40cc of clear, serous fluid, which was sent for lab analysis. After sterile prep and anesthesia of the left knee, the knee was aspirated of 60cc of clear, serous fluid. Following these procedures, the patient was able to move her feet again and felt better and started having feeling return to her feet. The physician's impression was "bilateral knee synovitis", for which he treated her with cortisone injections of "8 and 8". She was recommended to take ibuprofen for pain and to ice her knees. She was also recommended to have limited activity until her knees settled down and felt better. She was allowed to do heel slides and leg lifts. The patient was to call the physician in 2 days for follow-up and then to see the physician in the office the following week if she continued to have pain and problems. The lab results were expected to return on (17-sep-2009). The physician noted that there was no evidence of any infection in either knee at the time of her aspiration. The patient was discharged from the hospital on the day of report. No further information was provided. As of the date of receipt of this report, the patient's outcome was unknown. Manufacturer's comment: the benefit-risk relationship of synvisc is not affected by this report.


***

Event Date 08/12/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Deep vein thrombosis [deep vein thrombosis]. Leg stiffness [musculoskeletal stiffness]. Leg swelling [oedema peripheral]. Case description: spontaneous report received on 04-sep-2009 from a physician, and a pt regarding a female pt. The pt initiated a series of synvisc injections into the left knee approx two months prior, at a dose of 3x2 ml given in an interval of one week apart administered via intra-articular route. The pt relevant medical history included osteoarthritis, thyroid gland insufficiency and prior synvisc therapy (2007) without incident. The pt was in good general state of health. The pt received three synvisc injections into the left knee, the first injection being administered together with diprostene (1 ml, betamethasone dipropionate, sodium phosphate) the same day, the second six days later, and the last the following month. Six days later, following the last synvisc injection, the pt experienced left leg stiffness and swelling. The next day, the pt consulted her rheumatologist who decided to inject diprostene (betamethasone dipropionate, sodium phosphate) again. The following day, the pt saw her general practitioner. The general practitioner prescribed her ultrasound-doppler examination of inferior limbs. The ultrasound-doppler examination of the left inferior limb indicated thrombosis of iliacal vein, femoralis, communis, superficialis and profundi, thrombosis of popliteal vein and vena saphena magna from mid-thigh up to the angle. Vena cava was free of thrombi. Thrombosis was fresh and with a mild ultrasound signal. Conclusion was that a large extensive left sided deep vein thrombosis of popliteal, femoral and iliacal veins were found. The event of deep vein thrombosis was unk in intensity. The examination of right inferior limb was normal and with no thrombosis. The pt was hospitalized the same day, to clear the etiology of thrombosis. The pt was treated immediately with fondaparinux (7. 5 mg/6 ml). The pt had recovered and was discharged eight days later. The etiologic research was negative. The physician did not provide the relationship between the event of deep vein thrombosis and synvisc therapy. Investigation summary was received on 09-sep-2009: the product lot number was not provided therefore a batch record review is not possible. It is the requirement to review all finished batch records for specification conformance prior to release. Any specification result is identified and mitigated. Data is periodically presented and reviewed by individuals responsible for assuring product quality. This review has not indicated trends that could be associated with any product complaint. Genzyme will continue to monitor complaints. Mfr's comment: the benefit-risk relationship of synvisc is not affected by this report.


***

Event Date 08/04/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
In 2009, 10:30 a. M. , i saw my orthopedic physician in his office. He did an x-ray of my knees and recommended an injection of synvisc-one for my left knee. I had never had this med before and asked about side effects. The doctor told me no side effects except possible infection at the injection site. The doctor gave me an injections of synvisc-one at 11:00 a. M. And told me i could go home. I only walked a few steps down the office hall before i began to have the following side effects: dizziness, weakness, nausea, blurred vision, and trouble breathing. A pt in the waiting area saw my condition and called for the nurse. The nurse told me to sit down, that i was very pale, and was about to faint. The nurse took my vital signs and called emt. I was having chills, a facial rash, and shaking. I was taken by emt in an ambulance to the hosp and treated for an anaphylactic reaction. I was then discharged, but unable to drive home because of still having some side effects. Someone else brought me home. I continued to have these same side effects for seven days. Before this event, i had driven myself to the doctor's office, felt well, and was preparing for the beginning of school. Dose: 48mg in left knee. Frequency: once. Route: injection. Dates of use: 2009 single dose. Diagnosis: osteoarthritis. Event abated after use stopped: no.

***

Event Date 01/01/2007
Event Type Death Patient Outcome Death; Hospitalization Required Intervention
Event Description
Death nos [death]. Could not move body/had to lie flat in bed [immobile]. Removal of fluid from right knee [aspiration joint]. Swelling in the right knee/swelled to two times its size [joint swelling]. Case description: spontaneous report received on 12-dec-2007 from consumer regarding a male knee pain pt. The pt has a medical history of knee pain, kidney disease with dialysis and heart problems. The pt received his first dose of synvisc in 2007 administered via intra-articular route at a dose of 2ml in both knees. On an unk number of days after starting synvisc, the pt experienced swelling in the right knee/swelled to two times its size, could not move body/had to lie flat in bed, removal of fluid from right knee, and death. Synvisc was last administered prior to the reported event(s) eight months later. On an unk date, the pt was hospitalized, had a knee washout performed in the right knee and had "other unspecified treatments. " six months later, the pt died from an unk cause of death. As of the date of receipt of this report the pt outcome was dead. No concomitant medications reported. The company assessed the relationship between could not move body/had to lie flat in bed, removal of fluid from right knee, washout of the right knee as possibly related to synvisc. The company assessed the relationship between death as unlikely related to synvisc.

The Knee Geek/Guru Site

A friend of this blog contacted me last week. The The Knee Geeks/Guru forum deleted their profile, which resulted in the removal of their posts. This came without a warning, yet accused them of being "flagrantly commercial" for suggesting nontoxic solutions to pharmaceutical viscosupplementations. This poster first sought help from The Knee Geeks/Guru forum immediately following a life-threatening reaction to Synvisc. There they discovered that they were not alone. Their posts progressively turned into the solutions they'd found to help improve their health and other options for joint problems that worked for them, and others they know...including me. The Knee Guru's apparent tolerance for posters who approve of Synvisc or other viscosupplementations in a repetitious manner leads one to speculate whether they singled this poster out. Yet their "site ethos" states:

"Site ethos - this site is run by a medical professional, and professional standards apply.
Although the content may be couched in lay terminology as far as possible, the material is sufficiently educational to be relevant even to medical professionals themselves.
There is no skew of content due to pressure from sponsors. Every attempt is made to be honest with opinions."

If this is true, then why delete a profile from someone who truly suffered and offered their solution to those who have suffered, might suffer or will suffer?

The Knee Guru also site claims:

Funding - currently the site has no direct commercial sponsors. The site is owned by ftmg Associates Ltd. The site has a key philanthropist who wishes to remain anonymous, and who has a special interest in building the KNEEguru into a quality information resource for patients. We hope in time to attract academic funding from offering the site with its vibrant bulletin board as a fieldsite for academic study.

Yet the forum is surrounded by advertisers, including those promoting Synvisc/Synvisc One--hidden behind "OA Knee Pain Treatment--one injection gets up to 6 month..." and many others.

The deletion of this poster's profile also happened within days of disclosing that the FDA no longer allowed the public to read the actual "event descriptions" from patients or health care providers on the MAUDE data base. [Discussed further on Sept 28 post ] Note: this change in public access took place ONLY on the MAUDE site for "medical devices", which is how the FDA classifies Synvisc. [Which is also questionable since it apparently is metabolized and anything injected into the body will cause a chemical change.]

The goal of this blog is to make known the things that people SHOULD KNOW BEFORE they consent to Synvisc. And to let those who reacted and were dismissed by their physician(s) know--YOU ARE NOT ALONE. If I, along with the many others in contact with me had this information PRIOR to our Synvisc injections, our lives would be MUCH healthier today. We are ALL still struggling to return to our "pre-Synvisc" health status...years out from the injections.

Read this blog and MAKE AN INFORMED choice. And be careful who sponsors the clinical trial studies that you believe...follow the money!

FDA Adverse Event and Side Effect Reports--7

The FDA has removed the side-effects event descriptions as of Sept 2009 and made it harder for the consumer to make an informed consent. I will continue to share some of the descriptions that I've collected since my life-threatening reaction to Synvisc.

***
SYNVISC HYLAN G-F 20
Event Date 09/24/2004
Event Type Injury Patient Outcome Hospitalization;
Event Description
Weakness in legs, paresthesias below navel, inability to control legs, pain in both knees, swelling in both knees, left knee aspirated, pain in both legs, numbness in both legs. Initial information was received in 2004 from a physician regarding a pt, (age and initials unknown), who experienced weakness in the legs. The pt's medical history, indication, therapy dates, concomitant medications and outcome were not reported. The pt received synvisc injections to an unknown site on unknown dates. Sometime after receiving synvisc the pt experienced weakness in the legs which the physician reported was possibly related to a spinal tumor or growth and not related to the synvisc. No further info was provided. At the time of this report, the pt's outcome was unknown. Additional info was received 4 days later from the physician's office. The pt received synvisc in both knees 3 months ago, the following month, and 7 days later. Pt experienced pain in both knees and called the doctor. 3 days later, they reported increased swelling and pain in the knees. The doctor aspirated the left knee and sent the fluid for analysis; the fluid culture was negative. 3 days later, the doctor saw the pt again. 4 days later, pt experienced a sudden onset of paresthesias below the navel and inability to control the legs, and was hospitalized by the primary care physician. Mri results were negative. The duration of the hospitalization was unknown. 22 days later the pt experienced pain and numbness in both legs. The primary care physician thought the pt had a possible reaction to synvisc. At the time of this report, the pt's outcome was unknown.
.
***
Lot Number UINK
Event Date 05/01/2006
Event Type Injury Patient Outcome Hospitalization;
Event Description
Knee pain. Info was received on 5/10/06 from a product mgr, who received the info from a health care professional in regards to a pt initials unk. The pt received two synvisc injections into an unk knee on an unk date. On an unk day after the second injection the pt complained of severe knee pain. There were no systemic reactions. Due to the severity of the pain the pt could not continue the treatment course. The health care professional that administered synvisc was very experienced in performing intra-articular injections and did withdraw fluid before the synvisc injection. No causality assessment was provided. At the time of this report the outcome was unk. Follow-up info was received from a health profession on 7/14/06 in regards to this pt. The pt received two injections of synvisc into the left knee. The first injection was in 2006 and the second five days later. The pt did not receive the third injection. The pt experienced left knee pain, swelling and effusion; dizziness, decreased blood pressure, hand convulsions, and diaphoresis. The pt was hospitalized on an unk date. On two days 30 ml of effusion was removed. The decreased blood pressure was treated with fluid infusion and the hand convulsions were treated with calcium injection. The physician assessed the adverse events as definitely related to synvisc. At the time of this report the pt had recovered.
***

SYNVISC INTRA-ARTICULAR HYALURONIC ACID
Event Type Injury Patient Outcome Hospitalization;
Event Description
Angio-edema, rash; skin flushing; shortness of breath; bronchospasm. Information was received on 09-aug-2006 from a physician in another country, regarding a patient of unk sex and age, initials unk, with unk medical history, who experienced angio-edema and a rash. The patient began treatment with synvisc on an unk date. The patient received an unk number of synvisc injections into an unk site on unk dates. The patient developed angio-edema and a rash which lasted approximately 10 days after receiving the synvisc. At the time of this report, the patient's outcome was unk. The physician had not assessed the relationship of the events to synvisc. Additional information was received on 11-sep-2006 from the physician. He provided the patient's initials, date of birth and gender (female). The physician stated that on an unk date, approximately two hours post synvisc injection, the patient developed skin flushing and shortness of breath. No bronchospasm was indentified at that time. After four hours of care, the patient was discharged and then developed more intense shortness of breath with bronchospasm. The patient was admitted to the hospital and required frequent observations to control her symptoms. At the time of this report, the patient's symptoms were ongoing. The physician also stated that this patient had many psychosomatic issues and felt that many of the symptoms were patient subjective. He is uncertain about the relationship between the events and synvisc.


***

Lot Number U0601
Event Date 10/24/2006
Event Type Injury Patient Outcome Other; Required Intervention
Event Description
Left lower extremity pain, left lower leg swelling, left knee swelling, left knee inflammation, left knee effusion. Information was received on 31-oct-2006 from a sales representative regarding a male patient (age and initials unk) with an unk medical history, who experienced swelling in the knee, inflammation in the knee and knee effusion. The patient began treatment with synvisc in 2006. The patient received an unk number of synvisc injections in2006. On an unk date, the patient experienced swelling and inflammation in the knee. The time frame in relation to the synvisc injection was unk. The physician aspirated the knee and cultured the aspirate. Cultures were negative, except the white blood cell count was 22,000. At the time of this report, the patient's outcome was unk. Additional information was received on 06 november 2006 from the physician. It was reported that the patient was a male, with a history of moderate osteoarthritis with joint narrowing and osteophytes and prior treatment with non-steroidal anti-inflammatory drugs (nsaids). The patient received synvisc injections in 2006, 7 days later and 5 days later. Two weeks later, the physician aspirated the left knee and injected an unspecified steroid at an unk dose. It was reported that a venous duplex exam was performed by doppler ultrasound to further evaluate left lower extremity pain and swelling. The results of the ultrasound were as follows: normal exam of the left lower extremity deep veins. In october 2006 the synovial fluid lab results were as follows: culture and gram stain were negative for bacteria and white blood cell counts were elevated at 22,250/mm. At the time of this report, the events of left knee swelling, left knee inflammation and left knee effusion were resolving. The physician assessed the relationship of synvisc to the events as probable.

***

SYNVISC HYLAN G-F 20
Event Date 09/08/2004
Event Type Injury Patient Outcome Other; Required Intervention
Event Description
Info was received in 2004 from a pt, with a medical history of osteoarthritis who experienced right knee pain to ankle to toes, right knee swelling and can barely walk. The pt had not received prior synvisc injections. The pt began a treatment with synvisc in 2004. On an unknown date the pt began to experience swelling in their right knee and pain that started behind the knee and went down to their ankle and toes. The pain was described as "debiltating. " the pain was worse now then prior to synvisc. The pt could barely walk after trying to get up from lying down. At the time of this report, the pt continued to have pain and swelling. Additional info was received three months later from the physician. The physician reported that the pt has a history of moderate osteoarthritis with x-ray grade iii, joint narrowing and osteophytes. The pt was treated with nsaids and steroids in the past (date unknown). The pt received injections into the right knee in 2004. A week later, following the third injection the pt experienced pain, swelling, effusion and lower leg swelling. Effusion was not collected before any injections. A month later, the pt was treated with intra-articular cortisone injection. The physician assessed the symptoms as injection related. At the time of this report the pt's outcome was unknown. Mfr's comment: synovial fluid or effusion should be removed before each synvisc injection. Qa investigation results: review of data did not indicate trends that could be associated to any product complaint.

Are Search Engines Bias??

Out of curiosity and due to some recent events, I decided to try out 4 search engines to see what came up when searching for adverse events/reactions relating to Synvisc injections. Google, Yahoo and Dogpile had the SynviscSurvivor blog either on the first or second page, yet on Bing/Microsoft...it never showed up after 10 pages, so I stopped.

I took it one step further and searched "Synvisc Survivor". Google, Yahoo and Dogpile both had this site as number one, as they should since it's a perfect match. I searched "Synvisc Survivor" on Bing/Mircosoft, and this site NEVER showed up! I searched "Synvisc Survivor Blog", and after 10 pages, I stopped. I even searched the exact web address...and this site didn't show up on it's own. But I did see where others have graciously posted this web address for seeking and hurting people to "get informed", and that's a GOOD thing...at least until someone deletes them, as noticed on popular knee forum full of gurus this past week.

Thank you to those who really care enough about other's health! And thanks for making a REAL difference in the lives of others.

So it seems that where you search for information does matter!

***

Opinions expressed here are strictly that of the poster who suffered tremendously from Synvisc injections. These opinions are not meant to replace medical advice, diagnosis or treatment. Seek a QUALIFIED naturopath for advice and help, or a physician who seeks truth! Never delay or disregard seeking professional medical advice from your physician or other qualified health provider because of something you have read on SynviscSurvivor. SynviscSurvivor does not endorse any specific product, service or treatment, yet will share what helped them if asked privately. If you think you have a medical emergency, call your doctor or dial 911 immediately

Synvisc Not Systemically Absorbed?

I read this Q&A between a potential patient and a physician at this link

http://www.hopkins-arthritis.org/ask-the-expert/treatment-013003/negative-reactions-to-synvisc-571.html.

Information from the physician claims that Synvisc is not systemically absorbed.

According to the following statement with sources, the resident [joint capsule] half-life is days to a few weeks at the most.

Synvisc® may last for a few days (Fiorentini R. , Proceedings of the US FDA Advisory Panel on Orthopaedic and Rehabilitation Devices, 11/21/96 Fairfax (VA) : CASET Associates, 1996; Berkowitz D., Proceedings of the US FDA Advisory Panel on Orthopaedic and Rehabilitation Devices, 11/20/96 Fairfax (VA) : CASET Associates, 1996).

My question to those reading this blog:

If Synvisc leaves the joint capsule in that time frame, and doesn't go "systemic" or is "not systemically absorbed" ...

Where does it go? I'd really like to know.

FDA Adverse Event / Side-effect Report 6 -- Synvisc (H-G 20)

The FDA MAUDE site still fails to show descriptions such as the following relating to Synvisc injections or any other medical device as of late Sept 2009. As a person who went from INCREDIBLE health to barely surviving and hanging on the last 2 years DIRECTLY FOLLOWING SYNVISC injections, these event descriptions are TOO important to keep to myself. People need to know what COULD happen if they consent to Synvisc injections. And the probability is historically HIGH that Genzyme, your injecting physician and other physicians will NOT be on your side if something goes wrong. Had I known this information prior to my consent, the last 2 years of my life would've been MUCH healthier and productive...and there are many who've contacted me privately who experienced the same! Take HEED before you consent to this product, and do your research before you consent to ANY DRUG or MEDICAL DEVICE. Unfortunately the FDA just made it more difficult by removing the event descriptions from the reports. Contact your US representatives and the FDA [1-888-463-6332] and let them know that this is NOT OKAY.

Here are some FDA MAUDE site reports that I have in my files.

****

Event Date 12/06/2007
Event Type Injury Patient Outcome Hospitalization;
Event Description
Numbness of fingers and toes, chest tightness, elevated blood pressure, facial flushing. Information was received from a physician on 07/dec/2007 about a female patient, age and initials unknown, who experienced a stroke and shortness of breath after her first synvisc injection. The patient received her first synvisc injection into the (unspecified) knee during "the week of four days earlier". The patient experienced a stroke "shortly after" the injection. She was taken to the or and it was determined not to be related to synvisc. She has recovered "and is fine". The patient also experienced shortness of breath. The events were reported to have occurred on the same month. The physician assessed the relationship of synvisc to stroke as unrelated; he assessed the relationship of synvisc to shortness of breath as unknown. Additional information was received from dr. Copeland's physician's assistant on four days after the original date. She reported that the patient is a female with a medical history of osteoarthritis and an arthroscopy 1-2 years ago, on estrogen supplementation. The patient received her first synvisc injection on three days prior to original date for a dry, non-effused osteoarthritis knee. The injection was uneventful. Forty-eight hours later, the patient called the physician complaining of facial flushing, numbness of fingers and toes, and chest tightness. There was no shortness of breath, wheezing, laryngeal edema or rash. The patient had no history of asthma, or other pulmonary or cardiovascular disease. At the doctor's office, the patient's blood pressure was elevated at 160/100. The physician treated her with benadryl and depomedrol. She did not respond and was sent to the emergency room, "where she was cleared for cvx and cva. She was sent home on no medications. It was reported that over the past week, the patient has done better, off all meds". At the time of this report, it was not known if the patient had recovered.

****

Event Date 07/17/2007
Event Type Injury Patient Outcome Other; Required Intervention
Event Description
Anaphylactic shock; asthma flare; nausea; shakiness; allergic reaction; soreness of the left knee; bruising of the left knee. Initial info was received in 2007 from a female pt who is also a registered nurse, with a history of knee pain, who experienced anaphylactic shock, nausea, and shakiness after receiving synvisc. On the same day, the pt was administered the first synvisc injection of the series in the left knee. Later that day, the pt experienced shortness of breath, syncope, nausea, diarrhea, and shakiness. She went to the er and was treated intravenously with benadryl and fluids. She was discharged from the er at 6:00 pm the same day. No further info provided. At the time of this report, the outcome of the pt was unk. Add'l info was received from the pt a week later. The pt stated that she experienced an allergic reaction on original date. No further info provided. At the time of this report, the outcome of the pt was unk. Add'l info was received from the pt on the end of the same month. The pt experienced a flare of asthma, soreness in the left knee, and bruising in the left knee on an unk date. The pt was treated with corticosteroids for the asthma flare. She stated that she experienced no significant reaction in the left knee from synvisc injections. At the time of this report, the outcome of the asthma flare was not yet recovered and the outcome of the soreness and bruising of the left knee was recovered. No further info provided.

****

Event Date 05/01/2007
Event Type Injury Patient Outcome Other; Required Intervention
Event Description
Tongue swelling; chest pain; throat swelling; not sleeping; ankle swelling; hives all over body; swelling in hands. Information was received on 14-may-2007 from a female patient with a medical history of osteoarthritis, who experienced tongue swelling, chest pain, throat swelling, not sleeping, ankle swelling, hives all over body and swelling in her hands after receiving synvisc. The patient received her first injection of synvisc on nineteen days earlier. Thirteen days prior to original date, the patient had ankle swelling. On the following day, the patient received the second synvisc injection. On two days later, the patient started to experience hives all over her body, throat swelling, tongue swelling, chest pain, not sleeping and swelling in her hands. The patient was treated with prednisone, zyrtec and atarax. At the time of this report, the patient had not yet recovered.

****

Event Date 01/01/2004
Event Type Injury Patient Outcome Hospitalization;
Event Description
Collapsed, head injury, broken nose, fractured right cheekbone, sweating, fast heart rate, extreme pain related to the injection, felt flushed. Information was received on 1/26/07 from a male patient via a sales representative regarding himself, with a medical history of osteoarthritis, who experienced a collapse, head injury, broken nose, fractured right cheekbone, sweating, fast heart rate, extreme pain related to injection and felt flushed. The patient began treatment with synvisc on an unspecified date about 3 years ago (2004). The patient received three injections into the right knee on unspecified dates about 3 years ago. On unspecified dates about 3 years ago, the patient experienced extreme pain related to the injection in his right knee following each injection. The pain after the third injection in his right knee was much worse. Shortly after the third injection while leaving the doctor's office, he experienced a fast heart rate ("his heart was pounding"), sweating, felt flushed and collapsed. He fell to the floor and experienced a head injury, a broken nose and a fractured right cheekbone. He had surgery to repair the injuries. The patient stated that he still had some residual effects from the fall, that can't be corrected, that he would have to live with the rest of his life, but his knee was fine.

****

Event Date 09/13/2006
Event Type Injury Patient Outcome Hospitalization;
Event Description
Systemic blood pressure increased; tingling lips; jittery feeling; tightness in chest; tachycardia. Information was received on 25-sep-2006 from a physician regarding a female patient with a medical history of osteoarthritis of the knee, who experienced tingling lips, a jittery feeling, tightness in her chest and tachycardia. In the past, the patient had a series of synvisc injections in the left shoulder in 2004, and series of synvisc injections in the left and right shoulder in 2006. The patient had received two injections of synvisc into the right knee eight months later and seven days following. The physician reported that within two hours of the patient receiving the second injection of synvisc, she started to experience tingling lips, a jittery feeling, and tightness in the chest. The patient was hospitalized on an unknown date with a systemic blood pressure of 190 and tachycardia. At the time of this report, the patient has recovered without sequelae and the physician has assessed the adverse events as possibly related to synvisc.

****

Event Date 07/28/2005
Event Type Injury Patient Outcome Hospitalization;
Manufacturer Narrative
The patient had a history of osteoarthritis in both knees for 10 years. The physician confirmed the events of "face swelled up" and "pulse was racing. " the physician was not aware of the patient's hospitalization. No causality assessment was provided.
Event Description
Information was received in aug 2005 from a pt with a medical history of osteoarthritis and previous synvisc injections in july/august 1999 and no history of allergies to chicken, eggs or feathers, who experienced voice was hoarse, face swelled up, neck swelled up, breathing difficulties, pulse was racing, felt lightheaded and dizzy. The pt began treatment with synvisc in july 2005. The pt received three injections on synvisc into both knees in july 2005 with one week interval. The pt stated that before their 3rd injection of synvisc pt noticed their voice was hoarse and two days later, their face and neck swelled up. In aug 2005, the pt had a "crisis" with their symptoms, their pulse was racing, pt felt lightheaded and dizzy like pt was going to lose consciousness. The pt stopped taking adderall at this point and since then there had been improvement in these symptoms; their heart rate and blood pressure have improved. In aug 2005, the pt hospitalized to determine what had happening and ruled out involvement of the thyroid gland. The cortisol levels came back low. The pt was released from the hosp. The pt took benadryl every night, otherwise pt had breathing difficulties and their face was still puffy. The pt had an appointment with endocrinologist to follow up on their symptoms pt had been experiencing. The pt also remembered having some type of breathing difficulties and their face was still puffy. The pt had an appointment with endocrinologist to follow up on their symptoms pt had been experiencing. The pt also remembered having some type of breathing difficulties around the time of their first series of synvisc injection in july/august 1999, but pt cannot remember whether the breathing difficulty was very close to the timing of the synvisc injections or not. At the time of this report the pt's pulse racing, blood pressure, lightheaded and dizzy had improved after discontinuing taking adderall. The pt continues to experience breathing difficulties and their face was stiff puffy.

****


Event Date 05/01/2005
Event Type Injury Patient Outcome Other; Required Intervention
Event Description
Hypersensitivity reaction, tightness in knee. Information was received in 2005 from a pt's family member regarding a pt with a history of osteoarthritis who experienced tightness in the knee and hives at various places on pt's body, some bruising, difficulty breathing and an allergic reaction to synvisc. The pt began treatment with synvisc in 2005. The pt received a series of three synvisc injections into the right knee in 2005. During the first week of the following month; the pt began to experience hives at various places on their body, and some bruising. The hives were treated with benadryl 50 mg tid and hydrocortisone cream. The treatment helped, but the hives came back if therapy was interrupted. The severity of hives had gotten progressively worse and during that same month the pt experienced difficulty breathing and went to the emergency room (er). Pt were placed on zyrtec (dose unknown) qd, prednisone 60mg as a single dose in the er and prednisone taper starting the following day at 40mg x 4 days, 30mg x 4 days, 20mg x 4 days, 10mg x 4 days, then discontinue. The pt was also prescribed pepcid (dose unknown) for stomach upset associated with prednisone. The pt's discharge diagnosis from the er was "allergic reaction to synvisc". In addition, the pt experienced "tightness in the knee" after each synvisc injection. At the time of this report, the pt's outcome was unknonw. Additional information was received in june 2005 from the pt's family member. The pt has a history of an allergy to feathers. In may 2005 the pt experienced swelling of their lips and chest tightness while being tapered off of the zyrtec tto allow allergy skin testing ("the pt needs to be off zyrtec for 4 days to allow allergy skin testing"). On an unknown date, the pt re-restarted their zyrtec 10 mg daily and the swelling on the lips and the chest tightness resolved. The pt was switched to benadryl 50 mg because they only had to be off of the benadryl for two days before skin testing could be done. In june 2005, approximately twelve hours after the last dose of benadryl the pt experienced face and lips swelling and hives cover every part of their body. Their lips "became so swollen the lips split. " on unknown date, the pt was seen in the er where they received solu-medrol by injection, benadryl by injection, prednisone and zyrtec. At the time of this report, the hives and swelling resolved. Additional information was received in june 2005 from a pt's family member who reported that the pt had a history of hypothyroidism, asthma and allergies. Family member stated that the pt's reaction was worsening, as they broke out in hives again that morning. She stated that the pt experienced bruising at times, after the rash and subsided. She noted that the allergist/hcps have hypothesized that the bruising occurs due to increased capillary perfusion subsequent to the rash. Family member stated that the pt was on prednisone and an antihistamine and was still experiencing the reactions. The pt was going to see an allergist the day of the call, but on previous attempts to taper the steroid/antihistoamine the reactions had reappeared and the allergy testing could not continue. The allergist was of the opinion that the reactions, because they were delayed, were not likely caused by synvisc. The allergist was checking to determine other possible causes. Additional information was also received in june 2005 from the pt. The pt confirmed they had a history of allergy to feathers, but they could eat eggs. The pt stated they had to go to er in 2005 because their lips were so swollen that they cracked and started to bleed, their face swelled, their eyes swelled and they had welts over their body with bruising. They stated that the reactions were getting worse over time.

FDA No Longer Includes Description of Adverse Event / Side-effects

Since I started to post the FDA Adverse Events relating to Synvisc reported to the FDA via patient and/or physician, they have since removed the ACTUAL DETAILS and DESCRIPTIONS of the events!!! They simply say "injury" or "hospitilized" or "intervention required."

Patients have the right to know what COULD happen to them if they take Synvisc or ANY OTHER drug or medical device. The FDA SHOULD be working for the people and that would mean full disclosure and description of adverse events.

I'll let you know if the FDA formate changes for the MAUDE search site and see if this changes with the "technical difficulty" declaration. I'll let you know when and if it does change.

Share your Synvisc story

Feel free to share your experience with Synvisc. If you had an adverse experience with this viscosupplementation, YOU are NOT alone.

FDA Adverse Event / Side-Effect Report 5 -- Synvisc (H-G 20)

Event Date 01/27/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Lack of muscle strength [muscular weakness]. Unable to roll over or get out of bed (mobility decreased) [mobility decreased]. Unable to ambulate [abasia]. Whole body locked up like an allergic reaction [hypersensitivity]. Case description: a spontaneous report received on 06-feb-2009 from the designee of a female patient with a history of arthritis, who experienced lack of muscle strength, decreased mobility, inability to ambulate, or her "whole body locked up like an allergic reaction" after starting synvisc. The patient received an injection of synvisc into the left knee the month prior. On the next day, the patient experienced a lack of muscle strength, she was unable to roll over or get out of bed, and unable to walk. The reporter commented that the patient's "whole body locked up like an allergic reaction". The patient stayed in bed the remainder of the week. On the following month, she was admitted to the hospital by her primary care physician. At the time of this report the outcome of the patient was unknown.

***

Event Date 02/05/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Pt is a woman who had synvisc placed in knee in office in late 2008. He started to feel gradually worse, and ended up hospitalized in serious condition with bilateral pleural effusions and pericardial effusion with essentially whole body reaction and inflammation. Pt responded quickly to large dose prednisone, and over the course of 6 weeks was gradually weaned off, and currently feels well. Three injections to right knee over 3 weeks of synvisc. Dates of use: 2008, 3 weeks - 3 injections. Diagnosis or reason for use: arthritis right knee. Event abated after use stopped or dose reduced? yes.

***

Lot Number NOT PROVIDED
Event Date 08/31/2008
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Event verbatim [preffered term] (related symptoms if any separated by commas). Arthroscopic surgery of right knee [arthroscopic surgery]; could barely walk [gait disturbance]; swollen right knee [joint swelling]; fluid in right knee [joint effusion]; pain in right knee/worse than before synvisc [arthralgia]. Case description: spontaneous report received on 20-nov-2008 from a female patient, initials t-h, who had a relevant medical history of arthritis of the knee and right knee pain. The patient received a series of synvisc injections in her right knee four months earlier. There were 2 weeks in between her first and second injections (the same month) and 1 week in between her second and third injections, with her last injection received in the same month. After she received her third injection, the patient rested for a few days as advised by her physician. The third injection given, her right knee became swollen and full of fluid. She experienced "severe" pain in the right knee and she could barely walk. She contacted her physician that same sunday, and he had her see him in the office. The physician drained the fluid in her right knee and had the fluid "tested". The patient saw the physician again for follow-up the following month, and he had to drain the right knee again. The physician then admitted the patient into the hospital on that thursday (same day). The next day, the patient had arthroscopic surgery in the right knee and stayed in the hospital for 5 days. She started physical therapy while in the hospital and was discharged with follow-up at her home by a visiting nurse and further physical therapy. She had to use a walker to get around at home. About 3-4 days after going home, her right knee had to be drained again. The right knee was drained about every 4-5 days after that for about 4 times total. She continued to have to use a cane to get around at home. She also continued to have pain, which was "more severe" than the pain she had before receiving synvisc. She said that she experienced "every side effect listed in the synvisc information" (she declined to clarify), so she felt that there was "something wrong with synvisc". She claimed that her life was "ruined". As of the date of receipt of this report the patient outcome was not yet recovered.

The Medical Device Safety Act & Physicians Payment Sunshine Act

The Medical Device Safety Act -- Track the progress at http://www.govtrack.us/congress/bill.xpd?bill=s111-540 Check out who supports and opposes this bill, and contact your representatives.

Synvisc is classified as a class III “medical device.” It received FDA approval through the Pre-market Approval process. This classification and means of approval by the FDA means that the pharmaceutical company, Genzyme, is protected from virtually any liability if something goes wrong with the injection. This leaves the door open for recklessness with NO accountability! And this includes ALL medical devices approved through this avenue. Not just Synvisc.

"This bill would overturn Riegel v. Medtronic, which held that the express preemption provision of Section 360k(a) of the Medical Device Amendment to the Food, Drug and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the FDA." [Read more about recent US Supreme Court decisions regarding Medical Devices.] Proposed Changes At FDA And Proposed Legislation Threaten Both Pharmaceutical And Medical Device Companies at http://www.mondaq.com/article.asp?articleid=76834Manufacturers of drugs are also seeking pre-emeptive protection based on "Riegel vs Medtronic." If you think prescription drugs are dangerous now, wait until their is NO legal recourse.


The Physicians Payment Sunshine Act 2009 would require transparency between pharmaceutical companies and physicians. YOU should know who "owns" you physician's decisions and opinions. Track it here http://www.govtrack.us/congress/bill.xpd?bill=s111-301 and contact your representatives to support this Act.

Chemical Injury.net

I encourage you to visit www.chemicalinjury.net for more information on the dangers of too much chemical exposure. This product will add to your load. Be aware.

Divinyl Sulfone is Allowed in Permissible Levels

Divinyl Sulfone

Acute and chronic mammalian toxicity: Sulfur mustard is a vesicant or blistering agent that possesses strong alkylating and consequently demonstrates systemic toxicity in addition to it's effects on skin, eyes and respiratory tract (2). It's also considered a known human carcinogen (59-61). Some HD degradation products retain considerable toxicity including, in some cases, vesicant action. Examples include mustard and hemimustard-TDG aggragates, mustard sulfone and divinyl sulfone. In general compounds that have a 2-chloroethylsulfide moiety are alkylating agents that have vesicant action.

"The Source, Fate and Toxicity of Chemical Warfare Agent Degradation Products Part 2" Article found in Environmental Health Perspectives Vol 107 #12 Dec 1999

Find more information on DVS by googling MSDS Divinyl Sulfone and read the safety sheet.

How is this TOXIC blistering agent "okay" to inject into the human body?

Synvisc Contains Formaldehyde

Synvisc contains formaldehyde in permissible levels, but apparently the FDA does not require Genzyme to disclose that information to the patient. Some may say that formaldehyde's half-life is short, yet before it metabolizes, it can leave a wave of destruction in its wake. And if you are chemically sensitive, even permissible levels of a chemical can be deadly. Don't count on your physician to take your health into consideration before saying, "You're a good candidate for Synvisc injections."

From http://www.chemicalinjury.net/

Formaldhyde activates NMDA. Formaldehyde also stimulates the brain vanilloid receptor. This receptor induces sensitization by activating the NMDA receptor, and increasing nitric oxide, which then increases perioxynitrite, and sets in motion neural sensitization. Vanilloid stimulation also increases the release of immune substance P...which is associated with reactive airway disease.

Explore this site and Chemical Injury.net to find out more. Also read more about permissible levels at http://ciin.org/pages/03-mcs.html

Trust me, the end result is NOT WORTH THE INJECTION.