Transvaginal Mesh Lawsuit - Pelvic Mesh Complication

Transvaginal Mesh Lawsuit Moved to Federal Court

Laura Woods | August 28th, 2013

Transvaginal Mesh LawsuitA transvaginal mesh lawsuit originally filed in the Court of Common Pleas of Philadelphia has been moved to the United States District Court for the Eastern District of Pennsylvania. Court documents state the reason the case has been moved is due to the diversity of citizenship that exists between the parties and because damages requested exceed $75,000. The claim also reasons that “federal question jurisdiction exists because plaintiffs have alleged substantial issues of federal law that are most properly adjudicated in federal courts.”

The plaintiffs, consisting of the patient and her husband, are suing Boston Scientific Corp. and Secant Medical Inc., after experiencing complications with a surgical pelvic floor repair mesh manufactured by the defendants, implanted in May 2012.

The implant was intended to treat the patient’s pelvic floor prolapse and/or stress urinary incontinence. In November 2012, the patient was forced to undergo corrective surgery to after experiencing severe vaginal mesh complications caused by the device. As a result of the defective implant, the patient claims to have suffered mesh erosion, mesh contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain, and recurrent urinary incontinence.

Transvaginal mesh lawsuit allegations

The plaintiffs are accusing the defendants of manufacturing, marketing, and selling the medical devices inserted in the patient without properly testing the product, despite having knowledge of their high failure and transvaginal mesh complication rates. The plaintiffs are suing the defendants on eleven counts, including:

  • Strict Liability — Defective Manufacture and Design
  • Strict Liability — Failure to Warn
  • Negligence
  • Common Law Fraud
  • Negligent Misrepresentation
  • Negligent Infliction of Emotional Distress
  • Breach of Express Warranty
  • Breach of Implied Warranty
  • Violation of Consumer Protection Law
  • Gross Negligence
  • Loss of Consortium

Vaginal mesh litigation against Boston Scientific

Nearly 5,500 lawsuits are currently pending under Boston Scientific vaginal mesh MDL 2326, in the U.S. District Court for the Southern District of West Virginia. Plaintiffs filed a transvaginal mesh lawsuit after having a device manufactured by the company implanted to treat pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), and consequently suffering alleged complications when the surgical mesh eroded through the vagina, causing them to contract infections and other severe health problems. Bellwether trials for the MDL are scheduled to begin on February 11, June 17, and September 9, 2014.

FDA warns of transvaginal mesh complication rates

The FDA has deemed transvaginal mesh complications are “not rare.”  In July 2011, the FDA issued a warning on vaginal mesh products, based on medical studies and nearly 4,000 reports of patient complications, showcasing the risks associated with transvaginal mesh POP repair. The warning suggested that using vaginal mesh to repair POP may not be the best treatment alternative, as previously believed.

Following the warning, in early 2012, the FDA sent a letter to several manufacturers of vaginal mesh products requiring them to run additional tests to ensure the implants were safe for patients and to determine if they do indeed pose a high risk of injury to women.

U.S. District Court for the Southern District of West Virginia, MDL 2326 Boston Scientific Corp. Pelvic Repair System http://www.wvsd.uscourts.gov/MDL/boston/