Two New Jersey-based companies are among the more than 30 businesses that must conduct studies and clinical trials on the safety and effectiveness of vaginal mesh implants, according to recent media reports. The U.S. Food and Drug Administration ordered the studies after receiving multiple reports of injuries and fatalities caused by the defective products, an agency spokesman said.
Approximately 30,000 women in Bergen County and throughout the U.S. received vaginal mesh implants in 2010 for treatment of incontinence or to support weak pelvic muscles. After receiving hundreds of reports or injury and death, the FDA ordered 31 manufacturers to study the rates of organ damage and other complications that result from vaginal mesh implantation. To date, more than 600 product liability lawsuits have been filed against Johnson & Johnson, C.R. Bard Inc., and other vaginal mesh manufacturers.
The FDA has also come under fire for clearing vaginal meshes for sale without conducting human testing. The mesh products were approved through the FDA’s 510(k) process, which permits products to be sold without any testing if they are similar to products already on the market.
According to media reports, the vaginal meshes that were approved by the FDA can be traced back to a mesh manufactured by Boston Scientific Corp. in the late 1990s. That product was ultimately recalled for safety concerns.
In a vaginal mesh implant, the hammock-like mesh is threaded in place through an incision in the vagina. Many women who have undergone the procedure have reported painful and potentially deadly complications arising from the edge of the mesh fibers cutting into or constricting their internal organs.
If you or a loved one has been injured as a result of vaginal mesh or another dangerous or defective product, please contact Breslin & Breslin for a free consultation.
Source: Bloomberg, “FDA Orders Safety Studies for Vaginal Implants Made By J&J and C.R. Bard,” Alex Nussbaum and David Voreacos, Jan. 5, 2012