The Food and Drug Administration has expressed serious concern about the high number of transvaginal mesh complications reported by women. At this time the FDA has not announced a vaginal mesh recall covering the many different mesh products currently being used. Sometimes called a bladder sling, pelvic mesh is implanted through an incision made into the vaginal wall. The device is designed to help correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI). There are several manufacturers, many of which have attracted severe criticism due to side effects caused by their devices after surgery.
Over the last several years, the FDA has received thousands of reports that detail complications ranging from vaginal bleeding and infection to urinary problems and mesh erosion. The pace at which such incidents have been reported has accelerated. Moreover, hundreds of transvaginal mesh lawsuit claims have been filed since 2011. In an effort to evaluate the problem, the FDA recently ordered 33 mesh manufacturers to prepare postmarketing studies of their devices’ safety and effectiveness. Many experts feel this demand may be a precursor to tighter restrictions down the road.
The Scope Of Vaginal Mesh Failure Complications
The FDA has reported that 300,000 women underwent vaginal placement of mesh for POP and SUI repair in 2010. Many patients prefer this option over abdominal surgery because it is less invasive, results in fewer visible scars, and is accompanied by a shorter recovery period. The downside is that transvaginal placement of the device has been linked to several serious problems, which prompted the FDA’s letter to manufacturers.
In addition to vaginal bleeding and infection, women have reported experiencing pain during sexual intercourse, vaginal shrinkage, and urine leaks. More serious complications include recurrent prolapse, organ perforation during placement, and neuromuscular disorders (disruptions in the communication between the nerves and voluntary muscles).
One of the most common problems reported is mesh erosion. The device begins to migrate through the body’s tissue. Most cases of erosion (sometimes called extrusion) involve migration through the vaginal wall. The surgical mesh may even move into the vaginal canal, causing severe pain and making sexual intercourse uncomfortable, or even impossible. On rare occasions, the device may migrate through the tissue of the bladder or rectum. Both circumstances are serious and warrant immediate medical attention.
The Goal Of The FDA’s Demand To Mesh Manufacturers
In July 2011, the FDA issued an update regarding the risk of vaginal mesh complications. They had previously reported receiving over 1,000 complaints of adverse events between 2005 and 2007. The number of complaints between 2008 and 2010 had nearly tripled. On January 3, 2012, the agency sent letters to 33 mesh manufacturers, ordering them to collect data related to the safety and efficacy of their devices. They were instructed to do so for three years.
The goal of the FDA’s letter seems to be to protect the public’s safety. The agency has expressed the desire to further evaluate the effects of transvaginal placement of mesh for POP and SUI repair. Given the high number of complications that have been reported – and likely an even higher number that have gone unreported – more scrutiny is needed.
Another factor that likely played a role in the FDA’s mandate is that most of the mesh kits sold today were approved through the agency’s 510(k) approval process. They evaded rigorous clinical trials for safety, and instead were approved based on a demonstration of “substantial equivalence” to previously-approved devices. Some pelvic mesh products were approved based on their equivalency to Boston Scientific’s ProteGen device, a product that was recalled years ago due to safety concerns.
Is A Vaginal Mesh Recall On The Horizon?
There is speculation that the FDA’s letter to mesh manufacturers represents a first step toward announcing a vaginal mesh recall. The agency has already considered categorizing the products as Class III medical devices, a designation reserved for products that pose a safety risk. With thousands of women already suffering from surgery mesh complications, and many others likely to develop problems in the months forward, this could be a step in the right direction.
If you received a vaginal mesh implant and have suffered any of the problems described earlier, you may be eligible to file a claim for compensation. Contact a transvaginal mesh lawsuit lawyer to discuss your options and the latest bladder sling recall news updates.
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