Lawsuits Continue Against Manufacturers of Vaginal Mesh Implants

Legal troubles for manufacturers of vaginal mesh implant systems continue to mount as an Ohio woman files yet another civil action against manufacturers with the U.S. District Court in Philadelphia, Pennsylvania. The lawsuit, filed in early August, states that the victim sustained a variety of personal injuries and seeks to recover compensatory and punitive damages from the device manufacturers.

The action has been taken against Endo Pharmaceuticals, based in Pennsylvania, and American Medical Systems (AMS) out of Minnesota and claims that the manufacturers withheld important information about the potential negative effects of the product from the public, doctors and patients.

In addition, the defendants are accused of failing to perform adequate research and testing, and of under-reporting and withholding information from the Food and Drug Administration (FDA) (www.fda.org) regarding the problems associated with the vaginal mesh implants.

The plaintiff was implanted with the Elevate Prolapse Repair System which was manufactured by American Medical Systems. In June 2011, AMS became a subsidiary of Endo Pharmaceuticals, complicating the legal issue of manufacturer accountability.

From Innovative to Dangerous

Vaginal mesh implants are facing many medical and legal issues. Used to treat urinary incontinence and to support weakened pelvic muscles, the implants now seem to be responsible for other problems, including infections, internal organ damage as well as other health complications.

Some women experience weakened pelvic muscles and urinary issues after childbirth, a hysterectomy or menopause, and the introduction of the vaginal mesh implant products was hailed as an innovative and effective treatment option for these women. However, as reports of complications are gathered, there is mounting evidence that the devices can cause bladder and yeast infections, bleeding, bowel problems and even return of the original bladder leakage problem.

FDA Continues to Address the Problems

FDAThe FDA stated in a report last year that there has been an alarming increase in the number of malfunctions, injuries and deaths linked to vaginal mesh implant devices. FDA data includes numerous reports of adverse events leading an advisory panel to strongly suggest that the devices be reclassified as “high-risk” devices. The reclassification would require additional clinical trials.

In July 2011, the FDA issued a safety communication highlighting the risks of vaginal mesh implant devices, stating that complications, including mesh erosion and vaginal damage, were not uncommon. In addition, earlier this year the FDA requested that all vaginal mesh manufacturers perform further after-market safety studies on their products in order to determine the extent of the problems.

Johnson & Johnson Pulls Their Products from the Market

Last month, vaginal mesh manufacturer Johnson & Johnson made the decision to discontinue sales and pull its Ethicon line of vaginal mesh implants from the market as they face more than 1,400 lawsuits related to the products. Currently, Johnson & Johnson is also attempting to be released from the after-market safety studies requested by the FDA.

According to FDA data in 2010, approximately 275,000 women received vaginal mesh implants for urinary incontinence and pelvic organ prolapse. The FDA continues to monitor event reports for these devices.

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