MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE HYLAN GF20; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 04/26/2012

Event Type  Injury  

Event Description

Injection of 48mm synvisc one into my right knee by dr (b)(6), an orthopedic surgeon.With a few hours i was experiencing burning, stinging and pain in the thigh and lower leg muscle of my right leg.This is 24 hrs a day and is only mildly relieved for short periods by nsaids such as ibuprofen and acetaminophen.I have been poisoned.I feel betrayed by my orthopedic surgeon, my medical group, but most of all by the fda.On (b)(6) 2012 i was given a knee injection of synvisc-one by my orthopedic surgeon that was supposed to replace the lack of cartilage in my right knee due to severe osteoporosis.Since that day my life has been pure hell.I am in pain 24 hrs a day.I have burning and stinging and pain in the lower leg and upper thigh of my right leg.It never goes away.I take nsaids to take the edge off of the pain and i am taking too many of them trying to get relief.My primary care doctor prescribed gabapentin, but it really hasn't helped very much with the pain.I called my medical group, care more, and the nurse on the help line talked with their pharmacy dept.They apparently have heard about the side effects of synvisc and said it basically has to wear out of my body which would probably take at least three months.I checked the internet and apparently i am not alone in experiencing synvisc side effects.I printed out 28 pages of testimony of people with the same side effects i have and some even worse that had to be hospitalized.There must be a hundred testimonies in those 28 pages, many by medical doctors.Yet this is still being injected into patients.The only warning is for people allergic to chickens , eggs and poultry.Some of these people are still fighting the side effects after 2 and 3 years.I am also reading that synvisc contains formaldehyde and divinyl sulfone in permissible levels and patients are not informed of this.How could the fda ever approve this drug? it is injected into the body.You can't just stop taking it like a pill.As i said before my life is pure hell now.I have no life.I am an invalid.I don't know how long it will take for this to be flushed out of my system.My primary care doctor recommended a knee replacement, but i feel like i was forced to try this injection first.Were any trials held on this drug? i would like to know how many complaints fda has received about it and why it is still on the market.Send me an acknowledgement.

• Brand Name: SYNVISC ONE HYLAN GF20
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10844181
• MDR Text Key: 216668725
• Report Number: MW5097908
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/02/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 74 YR
• Patient Weight: 69