Two manufacturers, Boston Scientific Corp. and American Medical Systems Holdings Inc., are at the center of a lawsuit, which alleges the companies sold defective transvaginal mesh products, causing severe harm to a patient.
In a complaint filed against Boston Scientific Corp. (NYSE: BSX) and American Medical Systems Holdings Inc. (NSDQ: AMMD), a patient is alleging mesh complications caused body tissue erosion, infection and a tendency to migrate from the original implant site.
This lawsuit is the latest incident in a string of events tying transvaginal mesh to surgical complications in over 3,874 patients. Reports of complications occurring after transvaginal mesh implants has forced the FDA to issue a Safety Communication, warning risks of complication are not rare and other forms of pelvic organ prolapse treatment may place patients at a lower risk.
Transvaginal mesh is used in surgeries to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when muscles and tissues around the pelvic organs become weakened or stretched, causing pelvic organs to bulge into the vaginal wall. SUI is characterized by a leakage of urine during moments of physical activity. Surgical mesh is inserted vaginally to strengthen the vaginal wall in POP and to support the urethra in SUI.
During POP and SUI treatments, the mesh implantations are implanted transvaginally, or through the vaginal wall.
However, recent FDA reports have linked transvaginal mesh implants to approximately 3,874 reports of injury death or malfunction. Most commonly, patients who have received transvaginal mesh implants experience mesh erosion through the vaginal wall, which may cause pain and decrease a patient’s quality of life.
Due to the recent reports of transvaginal mesh failure, the FDA is convening a public advisory committee on September 8-9, 2011. The panel will discuss scientific evidence in order to make recommendations regarding the safety and effectiveness of transvaginal mesh implants for POP and SUI repair. The panel may suggest placing additional restrictions or regulations on the transvaginal mesh devices.
While Boston Scientific Corp. and American Medical Systems Holdings Inc. find themselves in this current lawsuit, a 2008 report by the FDA stated that there are at least nine manufacturers who have made transvaginal mesh linked to complications in patients.
Other manufacturers who make transvaginal mesh implants include:
- Johnson & Johnson
- Boston Scientific Corp.
- American Medical Systems Holdings, Inc.
- CR Bard
- General Medical Devices
- Caldera Medical
Boston Scientific Corporation is a worldwide developer and manufacturer of medical products. It was founded in 1979 by John Abele and Peter Nicholas. It is listed as one of Forbes’ 100 most innovative companies. American Medical Systems Holdings Inc. was founded by Robert Buuck, William Bradley, Gerald Timm and Brantley Scott in 1972.
Do I Have a Transvaginal Mesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting transvaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by transvaginal mesh, you should contact our firm immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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