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.