Transvaginal Mesh Will Face Stricter Rules From FDA
Posted on behalf of Greg Coleman Law on Jan 05, 2016 in Product Liability
After years of reported complications and lawsuits resulting in multimillion dollar settlements, transvaginal mesh products will be facing stricter regulations from the Food and Drug Administration.
The FDA announced on Monday that the medical devices would be reclassified from moderate-risk to high-risk products and will require companies to submit an application with data from clinical trials before getting approved.
Although surgical mesh has been in use for decades, these new kits were first approved in 2002. The FDA issued a warning in 2008 after receiving over 1,000 complaints from affected patients. An update was again issued in 2012 ordering manufacturers to conduct postmarket surveillance studies to assess the safety concerns.
Vaginal Mesh Lawsuits
Three of the biggest manufacturers of the devices, Boston Scientific Corp., Endo International PLC, and Johnson & Johnson have faced thousands of transvaginal mesh lawsuits. Boston Scientific Corp. has already settled 6,000 claims for $119 million, while Endo International PLC has issued a whopping $830 million to settle 20,000 lawsuits.
In 2012, Johnson & Johnson discontinued sales of its transvaginal mesh products, although they claim it was unrelated to the lawsuits. They have since faced additional lawsuits.
Surgical Mesh for Pelvic Organ Prolapse
Vaginal mesh is used to repair pelvic organ prolapse, a condition where internal organs, such as the bladder or intestines, protrude into the vagina causing pain or discomfort. The condition is common among women after childbirth, where the walls of the vagina are weakened.
Because the surgical mesh is similar to mesh widely used to treat hernias, there was no requirement to report on clinical trial data under the previous moderate-risk classification. Critics have pointed to this as a serious flaw in the FDA's classification system, since the procedure was different and involved a different part of the body than hernia operations.
Complications are Severe
Many women have reported severe pain, bleeding, infection and other complications following procedures involving the mesh. In some cases the mesh can perforate organs or blood vessels.
Correcting the problems caused by transvaginal mesh require additional surgery, blood transfusions and drainage of abscesses. These corrective procedures are often painful, costly and time consuming, impacting the patients work and personal life.
If you or a loved one has suffered due to a faulty vaginal mesh, you may be entitled to compensation. The experienced product liability attorneys at Greg Coleman Law will work to get you justice. Call today for a free consultation.