Synvisc-One Recall of Contaminated Arthritis Injections

The manufacturer of an arthritis injection medication has voluntarily recalled thousands of potentially contaminated syringes containing an injectable gel indicated to treat people with knee osteoarthritis. The Synvisc-One knee arthritis injection recall is serious because contaminated syringes may infect patients with harmful bacteria, potentially causing significant adverse events such as pain and fluid buildup.
Speak to an Attorney Now

Weitz & Luxenberg Accepting Synvisc-One Lawsuits

For patients with osteoarthritis, any relief from knee pain and other uncomfortable arthritis symptoms may seem like a good thing. However, sometimes something marketed as a remedy can cause a worse problem.

The manufacturer of one type of an injectable knee arthritis gel has voluntarily recalled more than 12,000 potentially contaminated syringes.

We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.

(877) 616-5436

The name of the manufacturer is Sanofi Genzyme. The name of the recalled contaminated knee arthritis syringes is Synvisc-One.

Contamination of any kind can be serious because of possible adverse reactions to the contaminant, in this case a gram-negative bacteria.

Weitz & Luxenberg is currently accepting cases of people who were administered a recalled contaminated Synvisc-One syringe injection for the osteoarthritis in their knee and suffered serious complications.

We are also interested in hearing from you if a loved one received this type of shot and experienced severe complications, or even died.

Synvisc-One Injection Side Effects

A recalled lot of Synvisc-One arthritis syringes were found to be potentially contaminated with gram-negative bacteria.  These bacteria pose unique risks because they can result in infections that are resistant to many types of antibiotics. This means treating a gram-negative bacterial infection can be difficult.(1)

Sanofi Genzyme has notified the public that possible complications from a Synvisc-One syringe injection include:(2)

  • Pain
  • Swelling
  • Heat
  • Redness
  • Fluid buildup in or around the knee

We are interested in hearing from people who suffered serious Synvisc-One injection side effects within one week of receiving an administration of the gel.

We are accepting Synvisc-One lawsuits on behalf of those harmed by contaminated Synvisc-One syringes that were recalled.

Tainted Lot of Arthritis Syringes

The potentially contaminated Synvisc-One arthritis syringes were from one lot: lot identification number 7RSL021. These syringes were distributed from October 25, 2017, through early November. The manufacturer recalled these syringes on December 11, 2017.

These shots are administered directly to the knee joint in an effort to alleviate pain and other symptoms caused by osteoarthritis. Some Synvisc-One shots people received, however, may have been contaminated.

Contaminated shots could inject harmful bacteria directly into the knee joint, potentially resulting in infections and other side effects.

Patient being injected with Synvisc-One syringe

Did You Receive a Contaminated Arthritis Injection?

If you suspect you received a contaminated injection, we advise you to contact your doctor to see what injection you received.

If you are not sure if your injection was part of the recalled lot, reach out to us. Our attorneys are trained to investigate details regarding contaminated pharmaceuticals and medical devices.

We encourage you to contact us now at (877) 616-5436 or by filling out the form available on this page. One of our representatives will be in touch with you shortly.

Our attorneys can advise you of your legal rights and provide guidance regarding a potential Synvisc-One lawsuit. The consultation is free.

You may be eligible for compensation for:

  • Pain and suffering
  • Medical expenses
  • Lost wages or time off from work

Some Synvisc-One Arthritis Syringes Voluntarily Recalled

On December 11, 2017, Sanofi Genzyme voluntarily recalled more than 12,000 distributed syringes of the 18,000 syringes in lot number 7RSL021 due to possible contamination. The syringes contained injectable arthritis gel used in an effort to alleviate pain and other symptoms of knee osteoarthritis.(3)

The syringes in this lot were linked to dozens of adverse events reported in the FDA Manufacturer and User Facility Device (MAUDE) database.(4)

For a free consultation and more information about your legal options, please contact us today.

Get a Free Case Review

In its notice to hospitals, physicians, and clinics, manufacturer Sanofi Genzyme said the syringes affected by the urgent voluntary Synvisc-One recall were distributed between October 25 and November 7, 2017. The company initiated the recall because “investigational testing revealed the presence of microbial contamination.”(5)

At that time, Sanofi Genzyme said its recall was “being conducted with the knowledge of the US Food and Drug Administration” and that is was “working with your distributors to ensure that all product in lot 7RSL021 is returned.”(6)

“Use of this recalled lot may result in a risk of infection and therefore, we are asking that you follow the required actions below to assist us in retrieving any remaining units of this voluntarily recalled lot.”(7)

Stop Using Contaminated Synvisc-One Arthritis Syringes

Sanofi Genzyme asked recipients of its notice to “Immediately discontinue use of the Synvisc-One lot number 7RSL021” and that “Health Care Professionals should treat their patients exposed to lot 7RSL021 in accordance with standard of care, being aware of the potential of a Gram negative infection.”(8)

On December 19, 2017, the recall was posted in the news section of the Sanofi company website. The page included contact numbers for doctors who had received contaminated syringes.(9)

One week before issuing its voluntary Synvisc-One injection recall, Sanofi Genzyme sent an urgent “product hold” notice to doctors, pharmacists, and clinics instructing them not to dispense or administer the medication. The manufacturer said that particular lot of Synvisc-One was linked to “an unexpected increase in the number of labelled adverse events…”(10)

The recalled Synvisc-One syringes were manufactured at Sanofi Genzyme’s plant in Ridgefield, New Jersey. These syringes were distributed in 36 states.(11)

Man holding knee in pain

Synvisc-One Injectable Arthritis Gel

Synvisc-One was approved by the U.S. Food and Drug Administration (FDA) in 2009. Sanofi Genzyme has noted that common Synvisc injection side effects include pain, redness, swelling, heat, and fluid build-up in or around the knee.(12)

The active ingredient in Synvisc-One is hyaluronan. The manufacturer extracts the hyaluronan from chicken combs. A chicken comb is the crest you see on top of a chicken’s head. You can also find hyaluronan in human joints.(13)

As an injected gel, Synvisc-One is used in an effort to lubricate and cushion the knee joint.(14)

Patients may receive this arthritis injection gel in an orthopedic surgeon’s or rheumatologist’s office. A typical injection is supposed to provide pain relief for up to six months.(15) (16)

In 2016, Synvisc-One generated more than $400 million in sales.(17)

FDA Issued Warning to Sanofi Genzyme

According to The Boston Globe, the FDA warned Genzyme in 2001 about manufacturing problems at the company’s plant in Ridgefield. At that time, Genzyme manufactured an earlier version of Synvisc.(18)

The FDA instructed Genzyme to address the problems at its manufacturing facility. Otherwise, it warned, the company could face severe consequences.(19)

The FDA also raised the concern that Genzyme had not demonstrated the company had adequately looked into complaints about its Synvisc gel.(20)

Syringe Icon

A report received by Synvisc-One’s manufacturer on December 8, 2017 describes a patient who required a joint aspiration and then surgery for her infection in an attempt to flush out the knee arthritis gel after receiving an injection from the recalled lot.

Synvisc-One Adverse Events Reported to FDA

Currently, the FDA’s MAUDE database provides descriptions of dozens of reports of adverse events linked to Sanofi Genzyme’s Synvisc-One recalled lot of contaminated injectable arthritis syringes.(21)

Some of the cases describe patients requiring outpatient treatment as a result of receiving a contaminated injection. Such treatments included fluid aspiration, cortisone injections, and corticosteroid or pain medication prescriptions. According to other reports, some patients visited an emergency room, required hospitalization, or both.(22)

A report received by Synvisc-One’s manufacturer on December 8, 2017 describes a patient who required a joint aspiration and then surgery for her infection in an attempt to flush out the knee arthritis gel after receiving an injection from the recalled lot.(23)

Another report describes a woman who received an injection from the recalled lot of Synvisc-One who was diagnosed with “pseudo-sepsis” requiring several days of treatment in the hospital.(24)

Common concerns include a patient’s inability to walk or bear weight. Other adverse events include:(25)

  • Severe pain
  • Swelling
  • Decreased mobility
  • Immobility
  • Infection
  • Redness

Weitz & Luxenberg Accepting Cases of Contaminated Synvisc-One Arthritis Syringes

You may be entitled to pursue compensation from the manufacturer if you or a loved one received a contaminated injection of a Synvisc-One recalled syringe knee arthritis gel.

Please contact us if you received a contaminated Synvisc-One injection between October 25 and December 11, 2017, and suffered an adverse reaction within one week of receiving this injection. Your physician can inform you the name of the injection and lot number you received.

Weitz & Luxenberg is taking cases from people who developed an infection, required a trip to the emergency room, required intervention from their orthopedist or another physician, such as a joint aspiration or cortisone injection, were hospitalized, or died after receiving a contaminated injection of a recalled syringe knee arthritis gel Synvisc-One.

“The manufacturers made the right decision to recall the contaminated syringes in their Synvisc-One injected gel,” said Weitz & Luxenberg’s Drug & Medical Device Litigation Unit Practice Group Co-Chair Ellen Relkin. “However, they also have a responsibility to compensate victims of the contaminated knee arthritis syringes. I hope they will step up and do the right thing.”

Experienced Defective Medical Device Lawyers

If you believe you received a Synvisc-One knee injection from the recalled lot, we encourage you to contact us right away. We offer a free initial consultation and can advise you of your legal options.

Our attorneys have the knowledge and training to initiate Synvisc-One lawsuits on behalf of people who have received a potentially contaminated injection. Weitz & Luxenberg has more than 30 years of experience handling complex defective drug and medical device lawsuits.

We are also a national firm with a solid history of winning. We have secured billions of dollars in verdicts and settlements on behalf of clients who have been harmed by defective products.

Please call (877) 616-5436 or fill out the form on this web page for more information. Our representatives are available to discuss your case with you.

Although a past record does not guarantee future success, Weitz & Luxenberg has the experience and resources necessary to stand up to the manufacturers who sell defective medical products.

  1. Centers for Disease Control and Prevention. (2011, January 17). Healthcare-associated Infections. Gram-negative Bacteria Infections in Healthcare Settings. Retrieved from https://www.cdc.gov/hai/organisms/gram-negative-bacteria.html
  2. Saltzman, J. (2017, December 12). Sanofi Genzyme issues recall for contaminated arthritis gel. Retrieved from https://www.bostonglobe.com/business/2017/12/11/sanofi-genzyme-issues-recall-for-contaminated-arthritis-gel/ruFBNfmYSyJdMy9i7qwF8N/story.html
  3. Ibid.
  4. U.S. Food & Drug Administration. (2017, December 31). MAUDE – Manufacturer and User Facility Device. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm
  5. Sanofi Genzyme. (2017, December 11). Urgent: Voluntary Device Recall. Synvisc-One. Retrieved from https://www.aapmr.org/docs/default-source/news-and-publications/synvisc-one-customer-recall-lot-7rsl021-notification---hospital-and-physician-%283%29.pdf?sfvrsn=0
  6. Ibid.
  7. Ibid.
  8. Ibid.
  9. Sanofi. (2017, December 19). Voluntary Recall of Synvisc-One Lot 7RSL021. Retrieved from http://www.news.sanofi.us/Voluntary-Recall-of-Synvisc-One-Lot-7RSL021
  10. Saltzman, J. (2017, December 8). Sanofi Genzyme puts hold on arthritis medicine following surge in side effects. Retrieved from https://www.bostonglobe.com/business/2017/12/08/sanofi-genzyme-recalls-arthritis-medicine-following-surge-side-effects/JDKQI2zMEHobUXna7qoyUN/story.html
  11. Saltzman, J. (2017, December 12). Sanofi Genzyme issues recall for contaminated arthritis gel. Retrieved from https://www.bostonglobe.com/business/2017/12/11/sanofi-genzyme-issues-recall-for-contaminated-arthritis-gel/ruFBNfmYSyJdMy9i7qwF8N/story.html
  12. Ibid.
  13. Ibid.
  14. Ibid.
  15. Ibid.
  16. Palmer, E. (2017, December 12). Sanofi recalls arthritis injection that is tied to microbial contamination. Retrieved from https://www.fiercepharma.com/manufacturing/sanofi-recalls-arthritis-injection-u-s-tied-to-microbial-contamination
  17. Palmer, E. (2017, December 12). Sanofi recalls arthritis injection that is tied to microbial contamination. Retrieved from https://www.fiercepharma.com/manufacturing/sanofi-recalls-arthritis-injection-u-s-tied-to-microbial-contamination
  18. Saltzman, J. (2017, December 8). Sanofi Genzyme puts hold on arthritis medicine following surge in side effects. Retrieved from https://www.bostonglobe.com/business/2017/12/08/sanofi-genzyme-recalls-arthritis-medicine-following-surge-side-effects/JDKQI2zMEHobUXna7qoyUN/story.html
  19. Ibid.
  20. Ibid.
  21. U.S. Food & Drug Administration. (2017, December 31). MAUDE – Manufacturer and User Facility Device. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm
  22. U.S. Food & Drug Administration. (2017, December 31). MAUDE – Manufacturer and User Facility Device. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm
  23. U.S. Food & Drug Administration. (2017, December 8). MAUDE Adverse Event Report: Genzyme Biosurgery (Ridgefield) Synvisc One Intra-Articular Hyaluronic Acid. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=7156224&pc=MOZ
  24. U.S. Food & Drug Administration. (2017, December 7). MAUDE Adverse Event Report: Genzyme Biosurgery (Ridgefield) Synvisc One Intra-Articular Hyaluronic Acid. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=7156223&pc=MOZ
  25. U.S. Food & Drug Administration. (2017, December 31). MAUDE – Manufacturer and User Facility Device. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm

Get the Help You Need Today

Free Case Review