Synvisc-One Bacteria Contaminate Revealed
Last December, Sanofi Genzyme recalled 12,380 Synvisc-One syringes from lot number 7RSL021 sold nationwide in 36 states from October 25, 2017, through November 7, 2017, due to microbial contamination. Now, through a Class 2 recall, the company has revealed the Synvisc-One bacterium that has caused thousands of people to experience pain so intense that they are immobile.
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, however, patients experience harmful and dangerous side effects.
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. The company allegedly distributed a second notice on December 19, 2017, with this information, yet it didn’t reach all individuals who were adversely affected by the contaminated lot. This bacteria usually originates from environmental sources, such as water, soil, and sewage, however, studies have seen Methylobacterium species in healthcare-associated infections. The most troubling characteristics of this bacterium are that it is a gram-negative bacillus, which studies show it to be opportunistic pathogens in immunocompromised patients. Additionally, the Methylobacterium species can form a biofilm, which allows it to stick to many surfaces. Also, it is resistant to the majority of sanitation practices. Therefore, a traditional attempt at keeping a sterilized environment, such as using chlorine as a disinfecting agent would fail. Plus, this bacteria is slow growing. Therefore, it could have been present and infecting syringes for weeks or months before detection.
Synvisc-One Bacteria Contamination Theories
Without knowing Sanofi Genzyme’s manufacturing process, we cannot say for sure how the contamination occurred. However, it is possible that the bacteria came from a water source, possibly during the manufacturing process, and infected the syringes. This bacterium is chlorine-resistant. Therefore, even if the plant attempted to clean using traditional cleaning agents, it would not have worked. The bacteria would have remained.
Also, this bacterium isn’t one that people internally come in contact with. Therefore, it can send a horrific chain of reactions throughout one’s body after a medical professional injects it. One of these side effects is a pain so intense that the victim cannot walk. Some have reported to swelling so severe that doctors had to drain numerous vials of off-colored fluid from the knee.
Additionally, this Synvisc-One bacteria is very resistant to traditional antibiotic measures. Doctors have attempted to use dangerous fluoroquinolone antibiotics like Cipro. These antibiotics carry a black box warning for disabling and potentially permanent damage to tendons, muscles, and even the central nervous system. Additionally, studies link fluoroquinolones to causing aortic aneurysms and death. In fact, the FDA only recommends fluoroquinolones for extreme circumstances.
Many people after receiving the contaminated syringes from lot number 7RSL021 sold in 36 U.S. states from October 25, 2017, through November 7, 2017, are still in pain today, months later. They are still in excruciating pain after being infected by an antibiotic-resistant bacteria and Sanofi Genzyme is responsible. We are determined to ensure they give compensation to those affected by this Synvisc-One bacteria.
If you or someone you love received the Synvisc-One from the contaminated lot distributed between October and November 2017 and experienced a painful side effect, contact us today for a free, no obligation case review.