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By: Staff Writers | Published: July 5th, 2011
A Texas woman has filed a lawsuit against American Medical Systems (AMS) over problems with vaginal mesh manufactured by the company, which allegedly caused her to suffer a number of serious injures and complications after pelvic organ prolapse surgery.
The complaint was filed last month in Los Angeles Superior Court by Laura Jones, of El Paso, Texas, against AMS and a number of other unnamed manufacturers.
Jones had an AMS vaginal sling implanted in June 2009 to support her pelvic organs and restore normal vaginal structure. Following the pelvic organ prolapse surgery, Jones subsequently experienced severe pain, urinary problems and had to undergo a number of additional surgeries to have the AMS surgical mesh removed.
According to Jones’ lawsuit, the transvaginal sling eroded, shrunk and part of it extruded into her vagina. The complaint alleges that AMS failed to warn patients about the risk of vaginal mesh side effects, claiming that the manufacturer should be held responsible under theories of strict liability, negligence, breach of implied and express warranty, fraud, misrepresentation and violating California consumer protection laws.
In recent months, several other similar AMS vaginal mesh lawsuits have been filed on behalf of women who experienced problems after receiving pelvic organ prolapse products made by the medical device manufacturer. In March, a complaint was filed by Jeanne Ford of Georgia, and in April, a different lawsuit was filed by Michele and Albert Delorme of North Dakota. Both of those lawsuits were filed in Delaware.
Problems with vaginal mesh have been associated with products made by a number of different manufacturers. The FDA issued a warning about vaginal mesh complications in October 2008, indicating that more than 1,000 people had reported experiencing problems with products made by at least nine different manufacturers. In addition, a study published earlier this year found a high risk of problems with all vaginal mesh implants.
Last year, settlements were reached in a number of Mentor ObTape vaginal mesh lawsuits filed by women who experienced problems after receiving that product, made by a subsidiary of Johnson & Johnson. The complaints alleged that the complication rate associated with Mentor ObTape mesh could be as high as 17% to 18%. The Mentor ObTape was removed from the market in 2006, only three years after it was introduced.
Over the past year, a growing number of Bard Avaulta vaginal mesh lawsuits have also been filed by women who have experienced problems. All of the complaints involve similar allegations that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.
In October 2010, the federal Bard Avaulta litigation was consolidated as part of an MDL for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.