Woman continue to report injuries allegedly suffered as a result of being implanted with transvaginal mesh.
Transvaginal mesh (TVM) implants are medical devices approved to treat pelvic organ prolapse (POP), a condition in which weakened pelvic muscles cause organs to slide out of place. The device is also approved to treat stress urinary incontinence (SUI) and is meant to strengthen pelvic walls. Mounting litigation and growing adverse health reports question the devices’ safety and efficacy; many question if TVM devices pose more risks than benefits and TVM has been associated with very serious reactions, and not all are physical.
In one case, a number of infections following TVM led to intense pain, weakness, discomfort, and fatigue, said the Huffington Post. The woman had the majority of the TVM removed in October 2011, but said she continues to suffer from weakness and bladder leakage that causes her to have to take extra precautions when she leaves her home, said the Huffington Post. In another case, a woman says she experienced bleeding and severe pain immediately following her 2008 TVM surgery. The incision adjacent to her vagina never completely healed, she says she can feel the mesh, and she says she continued bleeding for two years. She ultimately had the mesh removed in 2010, although she says she continues to suffer from shooting pain and constant ache, among other issues, she said, according to the Huffington Post.
As we’ve previously written, the U.S. Food and Drug Administration (FDA) has warned that complications associated with TVM implants are “not rare.” The agency also stated that no clear evidence exists that TVM is better than non-mesh methods for treating POP and SUI and has asked 33 manufacturers to conduct post market studies evaluating the dangers of TVM. According to an agency Safety Communication issued last summer, the most common reported adverse events related to TVM include:
· Mesh erosion through the vagina (exposure, extrusion, protrusion)
· Pain during sexual intercourse (dyapareunia)
· Organ perforation
· Urinary problems
The Huffington Post pointed out that some physicians feel the mounting litigation and FDA’s warnings are misguided, blaming inexperienced surgeons for the more than 6,000 federal lawsuits against some key TVM manufacturers. The cases have been consolidated in a federal court in West Virginia; some trials are expected to begin this year, said the Huffington Post.
As we’ve explained, thousands of women were recipients of TVM devices, which have come under increased scrutiny since many recipients of these devices began experiencing complications related to their defects, including severe pain, erosion of the devices through the skin or tissue, serious infections, and the need for constant revision surgeries to either correct or remove the devices. TVM allegedly has a risk of erosion, in which it travels through the body’s tissues. In some cases, the device can become embedded in inappropriate areas and multiple surgeries are required to remove the TVMt. Sadly, in many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed.
Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety. The devices were approved through a fast-track process known as the 510(k), which means that a formal review for safety and efficacy was neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, such as metal-on-metal hip implants, the process has drawn increasing criticism.