By December of 2012, an estimated 8,000 lawsuits had been filed against manufacturers of transvaginal mesh products. These lawsuits have been filed by women suffering severe complications as a result of the use of this surgical mesh in procedures to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The number of women who have experienced severe complications gives rise to an important question: how did these dangerous products ever come on to the marketplace?
The Food and Drug Administration (FDA) regulates drugs and medical devices, approving only those devices that are believed to be safe for use. Unfortunately, much of the information provided to the FDA comes from manufacturers who produce the medical devices, and many of the transvaginal mesh products came onto the market with minimal or no testing because manufacturers took advantage of special 501(K) FDA approval rules. These manufacturers need to be held accountable for the dangerous products they unleashed on the public, and a Boston transvaginal mesh lawyer at the Jeffrey Glassman Injury Lawyers can help.
Transvaginal Mesh TimelineTo better understand the history of transvaginal mesh products and how these products came to market, consider the following timeline of events:
1950s: Surgical mesh was widely used for hernia repair and various products had been approved by the Food and Drug Administration.
1970’s: Surgical mesh began undergoing modification for use in other medical procedures including the treatment of stress urinary incontinence and pelvic organ prolapse (POP).
1996: The Food and Drug Administration approved the first transvaginal mesh product. The product was called ProteGen Vaginal Sling and was produced and marketed by Boston Scientific as a treatment for Stress Urinary Incontinence. The FDA approved the ProteGen Vaginal Sling with minimal testing under 501(K) rules because it was substantially similar to existing approved medical products. This means that the mesh was approved and sold to the public without human trials to prove that it was safe. The evidence provided by Boston Scientific justifying the release of the product was a three-month trial on rats and the similarity of the product to hernia slings and fabric used in cardiac surgery.
19998: The FDA inspected a Boston Scientific manufacturing plant in June of 1998 and determined problems with the device were worse than those being reported. The Star Ledger reported that the FDA learned “the number of [adverse] events being reported is approximately two-thirds of the complaints being made to the firm.” However, in August of 1998, the FDA inspection report indicated there was no reason for Boston Scientific to recall its product.
1998: Johnson & Johnson introduced a Gynecare TVT vaginal mesh sling under 501(K) rules because it was substantially similar to the ProteGen Vaginal Sling.
January 1999: Boston Scientific recalled the ProteGen vaginal mesh product after hundreds of reported complications. Women reported damage to their vaginal tissue, infection and discomfort or pain during sexual intercourse. Boston Scientific stated the device was being recalled because it did not “produce outcomes that are consistent with the company’s standard of performance for its products or customer expectations.” The recall had no impact on the Gynecare TVT nor on any future applications for FDA approval for transvaginal mesh products.
2002: The first surgical mesh product for the treatment of pelvic organ prolapse was approved by the FDA.
2003: Boston Scientific settled 739 lawsuits related to the ProteGen. The cases settled for an undisclosed amount.
October 2008: After receiving more than 1,000 reports of complaints related to transvaginal mesh products made by nine different manufacturers, the FDA released its first public health notification warning about complications associated with the use of TVM to treat POP and SUI. The FDA indicated that complaints from women related to transvaginal mesh included infections, mesh erosion, pain, discomfort during intercourse, vaginal scarring, bladder perforation and bowel perforation. However, the FDA described the complications as potentially serious but rare.
July 13, 2011: The FDA upgraded its warning from October 2008 in response to 2,874 additional complaints of adverse reactions. These complaints also included reports of bleeding, urinary problems, emotional problems, vaginal shrinkage, recurrent POP symptoms and neuromuscular difficulties. The FDA now cautioned that complications were not rare and that there was more risk to the use of transvaginal mesh products than with other surgical options.
September 2011: The FDA initiated an investigation of transvaginal mesh products to be conducted by an advisory panel of pelvic surgeons. The FDA also recommended that the transvaginal mesh product be reclassified until further testing could be performed.
January 4, 2012: The FDA ordered 33 transvaginal mesh manufacturers including C.R. Bard and Johnson & Johnson to conduct comprehensive three-year studies to determine the potential risks and complications associated with their TVM products.
January 2012: More than 650 lawsuits were filed alleging problems and complications from transvaginal mesh products.
February 2012: Three multi-district litigations arising from transvaginal mesh cases were consolidated into one.
2013: Bellwether cases were resolved and settlements begin to occur. Following a $2 million jury verdict against C.R. Bard, the transvaginal mesh manufacturer negotiated a settlement with an additional plaintiff.
Getting Legal HelpMany cases are still pending against transvaginal mesh manufacturers and tragically, more victims begin to experience complications due to transvaginal mesh every day. If you or a loved one was harmed by this dangerous medical product, contact Jeffrey Glassman Injury Lawyers today for help.