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Boston Scientific Wins Second Transvaginal Mesh Case in Massachusetts

Courthouse Steps

Boston Scientific has now won two transvaginal mesh lawsuits in Massachusetts state court.

On August 29, following two days of deliberation, a Massachusetts jury returned a Obtryx product liability verdict in favor of the defendant.

The state court judge presiding over the proceedings previously excluded both testimony from the doctor of the plaintiff and key evidence supposedly revealing the defendant knowingly used materials in the transvaginal mesh product that were unsuitable for use by humans. Her physician had agreed to testify that he would not have used the Obtryx sling if he had been aware of the polypropene used in the manufacturing of the product.

A supplier issued a material datasheet warning to the medical industry that the polypropene material was dangerous for human usage. The plaintiff originally planned to argue that Boston Scientific blatantly disregarded these warnings and tried to prevent the supplier from finding out that polypropene would be used to create its vaginal mesh products. However, the judge banned the jury from listening to any of these arguments.

The plaintiff has indicated she plans to file an appeal.

Transvaginal mesh lawsuits

Approximately 1,700 transvaginal mesh cases are currently pending in Massachusetts state court. Additionally, more than 60,000 lawsuits are pending against Boston Scientific and a number of other transvaginal mesh manufacturers. Plaintiffs originally sought the assistance of these products to repair pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), but now share common complaints that the products are defective and dangerous.

Trials held in state and federal courts across the country encompassing a number of vaginal mesh and bladder sling manufacturers have resulted in major wins for plaintiffs, with many receiving multi-million dollar settlements.

The Boston Scientific Obtryx sling will be the subject of litigation again in November, as a total of 11 Obtryx lawsuits have been consolidated in a West Virginia court. Additionally, Ethicon, a subsidiary of Johnson & Johnson, is currently involved in ongoing vaginal mesh litigation in the U.S. District Court for the Southern District of West Virginia.

In October, a bellwether trial is scheduled to begin in a Florida federal court, involving five plaintiffs who suffered as a result of the Pinnacle Pelvic Support System, made by Boston Scientific.

FDA warns of transvaginal mesh risks

On July 13, 2011 the FDA issued an update to an October 20, 2008 warning on vaginal mesh complications. The FDA cited surgical mesh used to repair POP “as an area of continuing serious concern,” based on a recent review of adverse events reported to the Agency and complications noted in scientific literature.

In 2008, the FDA noted that “Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.”

While the FDA had previously cited serious complications with surgical mesh for transvaginal repair of POP as “rare” in 2008, the updated statement was released to warn patients that these incidents are indeed “not rare.”

Additionally, the FDA warned that transvaginal mesh may pose a greater risk to women suffering from POP than standard non-mesh procedures. The statement noted that the Agency continues to monitor the impact of surgical mesh to repair SUI and will share findings in the future.

  1. Lexis Nexus, Jurors Return Defense Verdict In Massachusetts’ 2nd Pelvic Mesh Bellwether Trial

  2. U.S. Food and Drug Administration, UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication

  3. U.S. Food and Drug Administration, FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence