Severe Complications Prompt New Transvaginal Mesh Lawsuit

A transvaginal mesh lawsuit was just moved from the Court of Common Pleas of Philadelphia County to the United States District Court for the Eastern District of Pennsylvania.

On or about May 15, 2012, the plaintiff was implanted with one or more of Boston Scientific’s pelvic mesh products and/or Secant Medical mesh components. These are mesh devices used in surgical pelvic floor repair and are packaged as Advantage Fit. On or about November 2012, the plaintiff in this transvaginal mesh lawsuit underwent corrective surgery to remove one or more of the pelvic mesh products and components in an attempt to resolve at least one transvaginal mesh complication.

The plaintiff was originally implanted with the Boston Scientific and/or Secant Medical mesh devices to treat pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI), which are U.S. Food and Drug Administration (FDA) – approved uses.

Transvaginal mesh lawsuit alleges severe injury

The complaint alleges that the plaintiff sustained permanent injury; underwent corrective surgery; and experienced, and will continue to experience, significant mental and physical pain and suffering and financial or economic loss, including, but not limited to, obligations for medical services and expenses. The case also alleges that the transvaginal mesh devices and components are associated with high failure, injury, and complications rates; that the devices fail to perform as intended; and that patients implanted with the devices require frequent and, often, debilitation revision surgeries. Allegations also include severe and irreversible transvaginal mesh complications and damage that has affected a significant number of women, including the plaintiff in this complaint.

The defendants named in this lawsuit are:

• Boston Scientific Corp.
• Secant Medical Inc.
• Secant Medical, LLC
• Prodesco, Inc.

Transvaginal mesh complication reports lead to litigation

Tens of thousands of lawsuits alleging injuries associated with transvaginal mesh devices have been filed throughout the nation. The lawsuits contain allegations of manufacturing and design defects that have led to serious health complications, including:

• Mesh eroding in the vagina, bladder, intestines, and uterus
• Infection and pain, including neuropathic pain
• Dyspareunia (painful intercourse)
• Fistulas
• Prolapse recurrence
• Incontinence recurrence and other urinary problems, including urinary retention
• Scarring
• Perforation of the bowel, bladder, and blood vessels
• Vaginal scarring

Several multidistrict litigations (MDL) were established in the U.S. District Court for the Southern District of West Virginia to handle the growing number of vaginal mesh lawsuits against various manufacturers including Ethicon, Cotoplast, Boston Scientific and C.R. Bard. MDLs are organized when a number of complaints are filed that allege similar injuries associated with the same product(s). An MDL is a federal process under which the plaintiffs share in pre-trial processes, such as discovery, and is initiated to minimize duplicative efforts as well as to avoid conflicting judicial rulings.

FDA warns of serious vaginal mesh complications

Most transvaginal mesh implants receive FDA clearance through the 510(k) process. The 510(k) enables manufacturers to bypass stringent safety trials as long as the product is substantially similar to another which is already on the market. Since transvaginal mesh has been available to patients, thousands of adverse event reports have been logged with the FDA.

In October 2008, the FDA issued an alert concerning complications with transvaginal mesh when used in POP and SUI procedures indicating  that in the prior three years it received over 1,000 complication reports from nine surgical mesh makers. In 2011, the agency issued another notice concerning risk of “serious complications associated with transvaginal placement of surgical mesh for POP repair.” The most frequently cited complications were mesh erosion through the vagina, in addition to pain, bleeding and organ perforation.