Limited Synvisc-One Recall Issued Due To Microbial Contamination
Synvisc-One is an injectable prescription gel used to treat patients who suffer from osteoarthritis of the knee. Manufactured by Sanofi Genzyme, the Massachusetts-based biotech subsidiary of French multinational pharmaceutical company Sanofi S.A., Synvisc-One injections have increased in popularity recently. In 2016 alone, the injectable drug generated nearly $410 million in sales for Sanofi Genzyme, according to an industry news site, Fierce Pharma.
In late 2017, Sanofi Genzyme initiated a voluntary recall of more than 12,000 pre-filled Synvisc-One syringes after an ongoing internal investigation revealed microbial contamination in one particular lot of syringes. The contaminated syringes are linked to a number of adverse event reports.
If you suffered side effects or complications after being injected with a contaminated Synvisc-One syringe, you may be entitled to compensation. Here's what you need to know if you're considering taking legal action.
About Synvisc-One Injections
Synvisc-One (hylan G-F 20) is an injectable hyaluronic acid gel used to relieve knee joint pain associated with knee osteoarthritis.
Typically administered by rheumatologists or orthopedic specialists, the injected gel acts as both a lubricant and a shock-absorbing cushion. A single injection can provide up to six months of osteoarthritis knee pain relief, according to Sanofi Genzyme.
The U.S. Food and Drug Administration (FDA) granted Synvisc-One approval for use as a treatment for osteoarthritis knee pain in 2009. The injectable gel is made from hyaluronan (also known as hyaluronic acid): a viscous, slippery substance that lubricates human body joints and is also found in chicken combs, which are the fleshy crests on the top of chickens' heads.
Synvisc-One's active ingredient is hyaluronan extracted from chicken combs; it also contains inactive ingredients, such as saltwater.
Sinvisc-One Syringe Recall
In December 2017, Sanofi Genzyme initiated a voluntary Synvisc One recall, asking doctors and pharmacies to return 12,380 pre-filled syringes from a lot that tested positive for harmful microbial contaminants. The affected lot contained 18,000 gel-filled Synvisc-One syringes, which were manufactured at a Sanofi Genzyme facility in Ridgefield, New Jersey and bear the identification code “7RSL021.”
Sanofi Genzyme distributed 12,380 of the 18,000 syringes to doctors and pharmacies in 36 states between October 25 and November 7 of 2017 before an unexpected surge of related adverse event reports tipped them off to a possible contamination issue with the lot in question. Before recalling the lot, the company put a hold on it while conducting extensive testing to confirm the presence of a bacterial contaminant.
Symptoms Associated With Contaminated Synvisc-One Syringes
According to Sanofi Genzyme, the adverse events reported in connection with the contaminated lot of Synvisc-One syringes are consistent with those discussed on the drug's label. At this time, there are not any related deaths.
Patients injected with one of the contaminated syringes face an increased risk of infection and other health risks that may require hospitalization. Symptoms can include:
- Knee pain
- Swollen knee joint
- Heat in the knee joint
- Redness of the skin at the injection site
- Fluid buildup in or around the knee joint
- Decreased mobility
Not the First Sign of Trouble
Unfortunately, this contamination and recall incident wasn't the first sign that there may have been problems at Genzyme's Ridgefield, New Jersey facility. In 2001, the FDA warned Genzyme to resolve documentation issues and manufacturing deficiencies at the plant related to an earlier version of the drug, known simply as Synvisc—or face the consequences.
The FDA's concerns about the facility included medical incident reviews not coordinated with other quality control systems; inadequate investigations into product complaints; and a lack of research into potential problems caused by making the drug pre-loaded in syringes.
Sanofi S.A acquired Genzyme in 2011.
Consult an Experienced Personal Injury Attorney
McGartland Law Firm's award-winning team of personal injury attorneys is interested in speaking to patients who experienced painful side effects and complications after receiving Synvisc-One injections for knee osteoarthritis pain.
Our attorneys can investigate your case to determine if you were injected with a needle from the contaminated lot and if so, help you explore your legal options. Contact McGartland Law Firm today to schedule an appointment for a free initial review of your case.