In December 2017, an urgent Synvisc-One recall was issued that affects nearly 13,000 syringes used to treat osteoarthritis, due to a lot that tested positive for microbial contamination. Syringe contents must be sterile.
Manufactured by Sanofi Genzyme and FDA approved in 2009, Synvisc-One (Hylan G-F 20) is a hyaluronic acid injection used for the treatment of pain from knee osteoarthritis. However, doctors sometimes use these injections in other joints. These injections are for patients seeking stronger treatment over nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.
Synvisc-One injections use hylan A fluid and hylan B gel, made from a substance called hyaluronan, along with salt water. The syringe uses this gel-like mixture to relieve pain mainly associated with knee osteoarthritis or other joint pain. Hyaluronan, also known as sodium hyaluronate, is naturally present in healthy joints. The substance acts as a shock absorber and lubricant, allowing joints to move smoothly over each other. However, the substance appears to break down in people with osteoarthritis. Injecting it into a joint may lessen pain and inflammation. If non-sterile microbes contaminate the injections, then, patients experience harmful and dangerous side effects.
In December 2017, Sanofi Genzyme voluntarily recalled Synvisc-One, as a result of microbial contamination of lot number 7RSL021 sold in 36 U.S. states from October 25, 2017, through November 7, 2017. This recalled lot equates to 12,380 syringes. Investigators pinpointed that the microbe is a common airborne organism, which causes serious infections.
However, Sanofi Genzyme did not express which side effects prompted the recall. A representative of the pharmaceutical company stated the infected syringes increased the presence of side effects found on the label. The warnings listed on the package insert include pain, swelling, heat, redness, and fluid build-up in and around the knee.
Microbial contamination refers to the non-intended or accidental introduction of infectious material like bacteria, yeast, mold, fungi, virus, prions, protozoa or their toxins and by-products. Sanofi Genzyme has not conveyed which microbe caused the Synvisc-One recall. The company has only disclosed that the bacteria is gram-negative. Gram-negative infections are notoriously hard to treat because they are antibiotic-resistant.
Also, this isn’t the first time a microbe contaminated injections, and the result was catastrophic. Several years ago, plaintiffs secured a $100 million settlement after fungal meningitis contaminated steroid injections. The tainted injections ultimately killed 64 people and injured over 750 in 20 states. It was one of the worst American outbreaks of fungal meningitis.
This, in part, is why it is important to know which microbes are present in Synvisc-One to better treat the thousands suffering from its side effects. An airborne microbe can range from the common cold to the bubonic plague. Sanofi Genzyme needs to tell the American public what the non-sterile microbe contaminant is.
Microbial Contamination Symptoms
Patients suffering from contaminated syringes may experience any of the following symptoms:
- Knee pain
- Trouble walking
- Heat or redness
- Fluid build-up in or around knee
Several patients needed cortisone injections or joint aspirations to rectify the harm from these contaminated injections. However, many others experienced these painful side effects but also required hospitalization. This also means that many have mounting hospital bills all from one seemingly safe injection to help curb their pain. A legal claim could help defray these costs.
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury because of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other women and their families from needless distress.
We Want to Help Victims
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with medications, and it is the responsibility of manufacturers to provide this information. If you or a loved one has suffered any side effects from Synvisc-One, you should demand accountability from Sanofi Genzyme. Why did no one tell you?
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You also may be entitled to compensation for their injuries and damages. The types of losses we can help you recover include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and Pain and suffering
If a person dies from complications from a drug, family members may also be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if a jury finds the conduct of a company to be highly reckless, they may award punitive damages to punish the company and deter similar conduct in the future. If you received a Synvisc-One injection from the contaminated lot distributed between October and November 2017 and experienced a painful side effect, please speak to us to learn more about your rights.
The Michael Brady Lynch Firm is currently accepting cases in all 50 state. Please use the form on this page or call toll-free 24 hours a day at 877-513-9517.