Background on Transvaginal Mesh & Medical Mesh
In September 2011, the FDA issued a recall of transvaginal mesh devices. Boston Scientific Corporation’s Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE were recalled because they may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.
An FDA advisory panel also met to discuss the safety of medical drugs and devices, including transvaginal mesh, and recommended tougher premarket testing of vaginal mesh products and the reclassification of the devices to a Class III—the highest-risk category for medical devices—without recalling existing products.
A 2011 study released by the Journal of Obstetrics and Gynecology Canada (JOGC) on pelvic mesh procedures stated, “Until adequate effectiveness and safety evidence is available, the use of new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials.” Read the full JOGC report.
The FDA warned patients and healthcare providers in July 2011 of the risks associated with the use of transvaginal mesh and recommended they consider alternatives to for treating POP and SUI, conditions that may occur after childbirth and pregnancy. According to the FDA, nearly 40 percent of women between the ages of 35 and 54 suffer from SUI. In 2010, more than 10,000 women underwent vaginal mesh surgery to repair POP alone.
In an article published in an August 2010 issue of the Obstetrics & Gynecology, researchers reported that scientists had to stop a transvaginal mesh clinical trial early because women implanted with the mesh experienced too many complications. In the trial, which began in 2007, 65 women with POP underwent either surgery using the pelvic mesh or a procedure known as colpopexy that uses ligaments to help support the muscles. The trial was cut short in 2009 after researchers found that more than 15 percent of the women implanted with the mesh suffered within a period of only three months from vaginal mesh erosion, a potentially serious complication involving the protrusion of the mesh when the skin splits.
In October 2008, the FDA issued a public health notification alerting healthcare providers and the public about the increasing number of serious health issues associated with the transvaginal mesh. Reported complications include mesh from nine different manufacturers.