The FDA is reclassifying the surgical mesh implant devices in a higher risk category in order to require manufacturers to conduct clinical trials on people before receiving approval of the devices for sales.
According to the Reuters, the FDA ordered new safety studies for these surgical mesh implant devices which are used to hold pelvic organs in place. The reason for this move comes after a large increase in the number of complications reported by female patients. The complications with surgical mesh implant devices include infections, severe pain and erosion.
More than 1,500 reports flooded in regarding complications related to the repairs with mesh from 2008 to 2010. The reported complications included cases where the mesh eroded into the vagina and/or caused infection and bleeding.
Companies such as Johnson & Johnson and Boston Scientific will now have to conduct clinical trials on people in order to receive approval for the sale of these surgical mesh implant devices. The FDA has requested 35 manufacturers of transvaginal surgical mesh to conduct three year studies of several hundred women to study the side effects as well as the overall quality of life for these women.
There have been about 75,000 women who have received mesh repairs for pelvic organ prolapse in 2010 and about 200,000 women who received transvaginal repairs for stress urinary incontinence. A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
These devices were placed and sold in the market without any type of safety testing. In 2011, the FDA was alerted to the serious and painful complications that are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. The FDA also found the risky surgical mesh treatment of POP to be no more effective than traditional treatment.
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, you are not alone, and you have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, other financial burdens and the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.
Contact us, experienced medical device lawyers, for a free consultation. We will listen to your story and explain your legal rights to help you choose the best course for your claim.