Synvisc-One Injections Contaminated with Microbes
In December 2017, Sanofi Genzyme voluntarily recalled Synvisc-One, as a result of an airborne microbial contamination of lot number 7RSL021 sold in the United States from October 25, 2017, through November 7, 2017. This recalled lot equates to over 12,000 syringes.
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.
Investigators pinpointed that the microbe is a common airborne organism, which causes serious infections and other side effects found on the label. Therefore, Sanofi Genzyme voluntarily recalled Synvisc-One. However, Sanofi Genzyme did not express which amplified warning on the label prompted the recall. 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, or virus. Sanofi Genzyme has not conveyed which microbe caused the Synvisc-One recall. Hence 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.
The Michael Brady Lynch Firm has over 20 years of experience fighting manufacturers who harm consumers. 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.
Therefore, 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.