Transvaginal Mesh Revision Surgery
As the unwanted and often inevitable consequence of transvaginal mesh (TVM) surgery, revision surgery occurs in a majority of mesh-implant cases. Once implanted through the vagina, TVM is known to erode or disintegrate, causing pain, bleeding and the risk of dangerous infections. Typically within weeks or month of implantation, TVM must be surgically removed. However, it’s not a simple process. It often takes even the most skilled surgeons several procedures to removed all of the mesh. In the meantime, women must suffered the pain and discomfort of having sharp shards of plastic in the vaginal area.
Researchers have found that TVM inserted to treat a pelvic organ prolapse (POP) or stress urinary incontinence (SUI) erodes once inside the vagina. Because TVM is typically constructed with polypropylene plastic coated with bovine collagen, it is attacked by the human immune system as a foreign body. This causes a inflammatory response that erodes the mesh into the surrounding tissue. Since this process takes weeks to months, the surrounding tissue grows through and interlaces with the fine mesh. This makes it impossible to remove in one piece.
Revision Surgery Alternatives
Many gynecologists try to use alternative procedures to alleviate mesh-erosion symptoms before recommending revision surgery. These alternatives include observation, estrogen-cream treatment and office excision.
If a patient does not have severe symptoms and is not sexually active, doctors often just observe the symptoms at three- to six-month intervals to ensure they do not get worse. For most patients, however, this is not a viable option. As a second-line defense, doctors prescribe estrogen cream as a mean to help alleviate symptoms.
The idea is that estrogen will plump the surrounding tissue and absorb the eroded mesh. However, there is little evidence to suggest this treatment works.
If estrogen offers no relief, doctors try to excise the eroded mesh in an office setting. Using a local anesthetic and a clamp, the pieces of mesh are yanked from the tissue and trimmed. And finally, if this is not successful, patients are referred to gynecological surgeons. However most will readily admit that revision surgery is painful and time consuming. It often takes two or three, or sometimes more, surgical procedures to remove all of the eroded mesh.
Transvaginal Mesh Federal Regulations
For this reason and others, many are hoping that federal regulators will crack down on TVM. All of the current TVM products being used across the United States are based on one faulty design that was voluntarily recalled in 1999. That’s because the U.S. Food and Drug Administration’s (FDAs) rules allow devices that are similar in nature to bypass FDA-mandated clinical trials and human testing. Seeing the error in this, the FDA is considering changing its medical-device clearance procedure and upgrading TVM to a high-risk device.
Transvaginal Mesh Legal Options
Today, scores of women have filed legal action in federal courts nationwide after TVM injuries. There are six multidistrict litigations (MDLs) involving the medical device manufacturers C.R. Bard, American Medical Systems, Boston Scientific, Mentor Corp., Johnson & Johnson’s Ethicon division and Coloplast Corp.
The federal court proceedings allow patients to band together for the purposes of discovery and pretrial proceeding, saving money and time. Each case, however, is heard individually, allowing injured patients to collect financial settlements based on the distinct circumstances of the case.
Already, one case involving C.R. Bard resulted in a $5.5 million award for the injured patient. A jury found that Bard’s Avaulta mesh product severely injured a 53-year-old woman.