Transvaginal Mesh Implant Manufacturers Face Lawsuits

More than 100,000 transvaginal mesh lawsuits have been filed, making it one of the largest mass torts in history. Many of these cases remain unresolved, but the multimillion-dollar settlements and verdicts that have been reached to date bode well for those who are currently awaiting the resolution of their cases.

What is Transvaginal Mesh?

Transvaginal Mesh is used to bring relief to women suffering from pelvic prolapse, as well as stress urinary incontinence. The mesh can be implanted through an incision in the abdominal wall or transvaginally. Both methods use the same transvaginal mesh implant.

Unfortunately, the mesh implants have been linked to a number of painful and serious complications. Mesh erosion, the most common complication, occurs when the mesh begins to deteriorate into small sharp pieces that can perforate nearby organs. Deterioration is due to sub par materials that may or may not have been United States Food and Drug Administration (FDA) approved and are used in the manufacturing of the implants.

Common Risks Surrounding the Use of Transvaginal Mesh

Though some countries have banned trasvaginal mesh, the U.S. lags behind and recent studies about complications are difficult to find. In 2011 the FDA conducted a search of the Manufacturer and User Device Experience (MAUDE) for reports on the adverse effects of surgical mesh products. The “search identified 3,979 reports of injury, death, and malfunction. Among the 3,979 reports, 2,874 reports were received in the last 3 years (January 1, 2008 – December 31, 2010).”

It was also in 2011 the FDA issued safety warnings to doctors and consumers about an increase in adverse event reports related to the mesh. The latest available FDA figures show approximately 300,000 women in the United States  undergo surgical procedures for prolapse each year, and approximately 260,000 underwent surgical procedures to repair stress incontinence. According to industry estimates, approximately one out of three prolapse surgeries used the non-FDA approved mesh, and of the incontinence surgeries, over 80% were done transvaginally.

Within the last decade, as the mesh has become widely used, more women suffering complications have come forward and class actions have been brought against manufacturers around the world. In 2012 the FDA reclassified transvaginal mesh implants as high-risk.

Transvaginal Mesh Manufacturer Error

Under product liability law, a product must meet the ordinary expectations of the consumer. Products that have an unexpected defect or danger generally fail this test. Defects typically fall into one of three categories: design defects, manufacturing defects, and marketing defects.

An injured patient bringing a transvaginal mesh lawsuit may argue that the mesh had a design defect since it wasn’t designed to serve its purpose for any length of time without eroding. Alternatively, they may argue a defect in the manufacturing process caused the mesh to erode into dangerous fragments long before its expiration date. Finally, the patient may claim the mesh was subject to defective marketing, in that it lacked proper warnings and was falsely marketed as a long-term solution to a number of conditions.

Johnson & Johnson, a leading mesh manufacturer, faces more vaginal mesh lawsuits than any other manufacturer. Some successful lawsuits brought against the company are as personal cases brought against the manufacturers.

  • December 2017: A Bergen County, NJ jury awarded $15 million to Elizabeth Hrymoc. Ms. Hrymoc said she received a defective Prolift mesh implant in 2008, which left her in such pain that she had to have it removed and replaced.
  • March 2018: A jury in Indiana awarded $35 million to Barbara Kaiser. She and her husband had sued Ethicon (a subsidiary of Johnson & Johnson) after Barbara Kaiser’s Prolift mesh allegedly caused her pelvic pain. She was awarded $10 million in damages and an additional $25 million in punitive damages.

CR Bard, another manufacturer of transvaginal mesh, has been involved in multiple lawsuits as well.

  • August 2015: In a class action suit, involving an estimated 3,000 cases, Bard agreed to pay more than $200 million, roughly $67,000 per case. Legal experts said the payout was made to avoid a string of multi-million dollar verdicts that could have lead to bankruptcy for Bard.
  • April 2018: A New Jersey jury awarded $68 million to Mary McGinnis, a woman who suffered debilitating injuries because of Bard’s pelvic mesh. The jury award included $33 million in compensatory damages and $35 million in punitive damages.

Boston Scientific is one of the top producers of transvaginal mesh devices. Boston Scientific faced significant jury verdicts against the company, which prompted it  to attempt to settle the remaining 20,000 cases against them.

  • October 2015: Boston Scientific announced it had settled around 6,000 mesh lawsuits for a total of $457 million through the 3rd quarter of that year. The news, based on a filing with the SEC, did not provide a breakdown of individual compensation per plaintiff.

Medical Malpractice & Transvaginal Mesh

Medical manufacturers and distributors aren’t the only ones who may be held liable for transvaginal mesh implant injuries and complications. Doctors and medical professionals are responsible for providing the proper information needed for women to make informed decisions regarding risks when undergoing procedures involving the mesh implant, and have a duty to perform surgeries within the standard of care.

Let Us Evaluate Your Case

If you or your loved ones have been injured due to medical negligence, the experienced medical malpractice legal team at Miller & Wagner is prepared to help you build a case. For more information on filing a claim in the State of Oregon, get in touch with one of our medical malpractice lawyers today.