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.

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.

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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.

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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.