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

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 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.


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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.

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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.

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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.


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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.


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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.

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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.

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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?

Warning to the Chemically Sensitive

Synvisc is billed as a viscosupplementation with limited localized adverse events [meaning in the injected joint], and little to no systemic adverse events [meaning on the whole body.] If you read the literature Genzyme, the makers of Synvisc, offers to their physicians and patients, you'd think the only exclusionary criteria would be if you have a known chicken, avian, feather, poultry, egg allergy. Genzyme, with the help of FDA, excludes listing or warning about the chemicals used in the cross-linking process allowed in permissible levels. These chemicals are formaldehyde and divinyl sulfone (DVS). Formaldehyde is a known neurotoxin and carcinogen. DVS is a by-product of mustard gas, and is more toxic.If you are hypersensitive to chemicals, do not let your physician inject this gel into your body.You will likely regret it.

More info will follow.

Take charge of your own health. There are other options.