Attention osteoarthritis injection users: there has been a Synvisc-One recall. In December 2017, Sanofi Genzyme voluntarily recalled Synvisc-One. This is 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.
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.
Synvisc-One Recall Information
Unfortunately, Sanofi Genzyme did not express which side effects or microbe 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 such as 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 are 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 also 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. Therefore, Sanofi Genzyme needs to tell the American public what the non-sterile microbe contaminant is.
Edit: On February 14, 2018, nearly two months after the manufacturer initiated the recall, the recall was updated. The company revealed that the bacterial contaminant in the syringes was Methylbacterium thiocyanatum.
Stop Using Syringes Involved in the Synvisc-One Recall
The FDA and Sanofi Genzyme recommend to Immediately discontinue use of the Synvisc-One lot number 7RSL021. One week before the Synvisc-One recall, Sanofi Genzyme sent an urgent “product hold” notice to doctors, pharmacists, and clinics. This instructed them not to dispense or administer the medication. In fact, they knew before the recall that their injection could bring an increased number of labeled side effects.
A plant in Ridgefield, New Jersey manufactured the contaminated syringes and distributed them to 36 states.
If Your Injection Was Part of the Synvisc-One Recall
Therefore, if your injection was part of the Synvisc-One recall, get justice now! 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 states. Please use the form on this page or call toll-free 24 hours a day at 877-513-9517.