FDA Orders Manufacturers Halt Distribution of Vaginal Mesh Products

 
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Transvaginal Mesh
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Transvaginal Mesh

In April of this year, the United States Food and Drug Administration (FDA) ordered all manufacturers of surgical mesh intended for transvaginal repair to stop selling and distributing their products immediately. The FDA made this decision after giving manufacturers Boston Scientific and Coloplast time to submit evidence that the benefits of these devices outweigh their probable risks. These companies failed to do so.

In 2011, the FDA reported that it received 2,874 reports of injury, death, malfunctions, and other complications related to transvaginal mesh from Jan. 1, 2008 to Dec. 31, 2010.

As of January 31, 2019, the agency said that it received 69,000 adverse events reports to POP mesh products. The adverse event reports included 64,000 injuries and 393 patients died.

However, the FDA’s action came too late for many women across the country. It took eight years for the FDA to issue any kind of definitive action on vaginal mesh. In that time, hundreds of thousands of American women have suffered irreversible damage from vaginal mesh. Many of these women required further surgery to remove the mesh and will live with chronic pain for the rest of their lives.

What is transvaginal mesh?

Transvaginal mesh is a net-like implant used to treat stress urinary incontinence. In addition, it serves as a repair for pelvic organ prolapse. The implant was originally used to repair hernias. Their use as a treatment for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) expanded in the early 2000s. 

However, at the time no tests or clinical trials were done to give doctors and consumers data on the medical device’s long-term consequences.

Notable transvaginal mesh lawsuits

In May 2019, a jury ordered Johnson & Johnson to pay $80 million in damages which included $50 million in punitive damages for a woman who received a mesh implant to treat pelvic organ prolapse.

Months after Patricia “Jill” Mesigian received the Prolift implant, she began experiencing vaginal bleeding. Doctors recommended a second surgery to treat her condition. Doctors found that the vaginal mesh implant sawed into her vagina. While doctors were able to remove the mesh, four years later, she was still experiencing pain during sexual intercourse and vaginal bleeding.

Eventually, doctors had to perform a third surgery on Mesigan to remove bits of mesh that remained in her vagina. Still, between 2013 and 2017, she required three additional surgeries to correct the lasting adverse side effects.

Timeline of notable verdicts and settlements

  • April 24, 2019 – Johnson & Johnson was hit with a $120 million verdict after finding in favor of a plaintiff who suffered incontinence and chronic pain.
  • February 2019 – J&J settles a majority of cases out of court.
  • August 2018 – J&J starts settling cases.
  • April 13, 2018 – A New Jersey jury hit vaginal mesh manufacturer, C.R. Bard with a $68 million verdict. The plaintiff was award $33 million in compensatory damages and $35 million in punitive damages.
  • September 2017 – A Philadelphia jury awarded a woman $57.1 million after it found J&J guilty of negligence because of its mesh product’s defective design.

What is the basis of transvaginal mesh lawsuits?

As mentioned above more than 100,000 vaginal mesh lawsuits have been filed over the years. Many of these lawsuits have resulted in multimillion-dollar settlements. In addition, these cases are still ongoing. The lawsuits are based on the defective design of transvaginal mesh that has led to serious injuries in women.

What are the reported complications from transvaginal mesh?

According to research, transvaginal mesh implants cause serious complication about 15%-25% of the time. Women often need revision surgery to remove the problematic mesh.

  • Bleeding
  • Chronic pain
  • Nerve damage
  • Vaginal scarring
  • Infection
  • Vaginal shrinkage (scar tissue)
  • Painful sexual intercourse
  • Neuro-muscular problems
  • Mesh erosion
  • Organ perforation

Hundreds of products, zero testing

From 2002 to 2013, because of a loophole that is supposed to speed up its  approval process , the FDA approved more than 100 vaginal mesh products. The FDA considered these products “substantially equivalent” to devices on the market, which does not require them to go through safety and effectiveness testing.

Manufacturers have sought out this process for millions of devices. In fact, roughly 60% of all U.S. device submissions seek approval through the “substantial equivalent” process.

 

This blog post was submitted by The Carlson Law Firm.

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