Phoenix Transvaginal Mesh – What is it?
Surgical mesh is a medical device that is used to repair weakened or damaged tissues. It is made from porous absorbable or non-absorbable synthetic material or absorbable biological material. Surgical mesh was originally developed in the 1950’s to repair abdominal hernias. In the 1990’s surgical mesh began to be used to treatment of women’s urological and gynecological problems including repairs of Pelvic Organ Prolapse (POP) and bladder lifts to treat Stress Urinary Incontinence (SUI). In POP procedures the mesh is permanently implanted to reinforce the weakened vaginal wall. In SUI procedures the mesh is used to support the urethra or bladder neck.
Manufacturers are allowed to market mesh products for transvaginal procedures based on claims that the procedures are “substantially equivalent” to the use of surgical mesh for hernia repairs. Based on these representations, the FDA has allowed manufacturers to market surgical mesh products for urogynecological procedures without conducting clinical testing to establish the safety and efficacy of mesh products for POP and SUI procedures.
Background of Bladder Mesh Slings
In 1996 Boston Scientific introduced the first transvaginal mesh (TVM) kit marketed in the United States. The ProteGen Sling System was developed by Boston Scientific to treat SUI. Based on Boston Scientific’s claim that the ProteGen sling was similar to hernia mesh products, the FDA allowed the ProteGen to be sold in the United States without first undergoing any clinical testing to establish whether it was safe for use.
In the first two years after receiving clearance to market the ProteGen sling, Boston Scientific received numerous reports of problems with the mesh including infections, vaginal bleeding, and erosion (damage to the vaginal wall). Accordingly, in 1999 Boston Scientific recalled all unsold ProteGen mesh products.
After Boston Scientific began selling the ProteGen sling, other companies began marketing TVM products. Like the ProteGen, these other TVM products were cleared by the FDA without undergoing any clinical trials. Even though the ProteGen sling was recalled, nevertheless, other mesh manufacturers referred to the ProteGen in their applications to the FDA. All of the mesh products sold today have been cleared by the FDA based on claims that the mesh is “substantially equivalent” to the ProteGen sling or to another product developed from the ProteGen.
If you are having problems due to a transvaginal mesh implant, contact me, Richard Langerman, to arrange for a free consultation and case evaluation. You will pay no attorney’s fees unless I recover financial compensation in your vaginal mesh case.
Law Office of Richard Langerman
4506 N. 12th Street
Phoenix, AZ 85014
Telephone: (602) 240-5525