In mid-December 2017, pharmaceutical manufacturer Sanofi Genzyme voluntarily recalled 18,000 to 20,000 of its Synvisc-One knee injection syringes due to microbial contamination.
The contaminated syringes (lot number 7RSL021) were distributed to doctors and healthcare providers in the United States from October 25, 2017, through November 7, 2017. The Synvisc-One knee injections that were recalled have been linked to an increase in negative side-effects and adverse events reported to the Food and Drug Administration (FDA). The medication has been a huge financial success for the manufacturer; Sanofi Genzyme reported sales of the syringes amounted to almost $410 million in 2016.
The Synvisc-One was approved by the FDA in 2009 to alleviate pain from knee osteoarthritis. Doctors began using these injections to specifically relieve arthritis pain in the knee, but over time, they used it to ease symptoms of arthritis in other joints as well.
Synvisc-One injections use gels which are composed from a mixture of hyaluronan and a saline solution. Hyaluronan is a natural chemical found in healthy joints. It acts as a shock absorber and lubricant. An ongoing regimen of Synvisic-One injections is necessary to relieve pain since it dissipates over time.
When investigators found microbes in the above-mentioned lot of Synvisc-One, Sanofi Genzyme was forced to issue a voluntary recall. The microbe – a common airborne organism, which causes serious infections – can also lead to certain negative side effects. Microbial contamination generally refers to infectious material like bacteria, yeast, mold, fungi, or some sort of bacterial virus. But Sanofi Genzyme has not disclosed which specific microbe(s) caused the Synvisc-One recall.
Patients suffering from contaminated syringes reported suffering from one of or a combination of the following symptoms:
- Knee pain and discomfort
- Knee swelling
- Difficulty walking
- Heat and/or redness in or around the knee
- Fluid build-up in or around the knee.
Many who have reported suffering these painful side effects required hospitalization or had to visit an Emergency Room or Urgent Care facility. This medical care has produced mounting hospital bills and other expenses associated with Synvisc-One contaminated injection including lost income due to their hospital stay and, often, acute pain and suffering. A legal claim to recover expenses arising from this defective medication could help those affected to defray these costs.
If you or a family member has been treated with a defective Synvisc-One injection from the contaminated lot number 7RSL021 that was distributed to healthcare providers from October or December 2017 and experienced any of the above painful side effects, you should speak with a seasoned defective drug injury lawyer as soon as possible to learn the full measure of your compensation rights.
Filing a defective Synvisc-One lawsuit empowers you to potentially receive full and fair compensation for your hospital bills, associated medical costs, and other damages which may be owed to you.
Contact Terry Bryant Accident & Injury Law for a free Synvisc-One consultation by filling out our simple online contact form or by calling (800) 444-5000. You pay nothing unless we win satisfactory compensation for your injuries.