BLOG

FDA Orders Transvaginal Mesh Products Off Market


transvaginal mesh held by doctor

The United States Food and Drug Administration (FDA), on April 16th, 2019, ordered all manufacturers of surgical mesh products intended for transvaginal treatment of pelvic organ prolapse to immediately cease distribution and sales of these products.

The FDA had classified these products as Class III, high risk in 2016, and this meant that the products’ manufacturers, Coloplast and Boston Scientific, needed to reasonably assure the FDA that the products were effective and safe. This assurance never came, leading to the decision to order that distribution and sales of the products be halted.

The announcement is the latest development in a long saga which began in 2008 when the FDA warned of complications related to the transvaginal use of surgical mesh for the treatment of pelvic organ prolapse and stress urinary incontinence. This warning was followed in 2011 with a safety communication and an analysis regarding transvaginal mesh.

The analysis listed vaginal mesh erosion, pain (including during sexual intercourse), urinary issues, infection, organ perforation and bleeding as common problems reported with implantation of transvaginal mesh. Neuromuscular problems, recurrent prolapse, emotional issues and vaginal shrinkage/scarring were also listed as reported problems in the analysis. The analysis identified three deaths associated with the use of transvaginal mesh.

The FDA ordered 34 manufacturers of transvaginal mesh to conduct post-market surveillance studies in September 2011. Most transvaginal mesh manufacturers ceased marketing surgical mesh for the treatment of pelvic organ prolapse after this order.

Many women have been awarded compensation for their transvaginal mesh injuries.

  • R. Bard was ordered to pay a North Carolina woman $68 million in 2018 for damages related to chronic pain caused by her implanted transvaginal mesh.
  • Ethicon Inc. was ordered to pay a Pennsylvania woman $57.1 million in 2017 for damages related to her transvaginal mesh eroding through her urethra three times, necessitating three revision surgeries.
  • Ethicon Inc. was also ordered to pay a Pennsylvania woman $41 million in 2019 for damages related to the nine revision surgeries necessitated by her transvaginal mesh.

The transvaginal mesh lawyers at Nadrich & Cohen, LLP have been pursuing transvaginal mesh claims since 2010 and continue to represent women who have been harmed by the defective transvaginal mesh products.

If you believe that you may have a defective mesh claim, contact Nadrich & Cohen today for a free and confidential case evaluation. Time is of the essence, as many manufacturers have settled or are settling with injured transvaginal mesh patients.

Learn More...


April 16, 2019

FDA Orders Transvaginal Mesh Products Off Market

The United States Food and Drug Administration (FDA), on April 16th, 2019, orde...


June 11, 2019

Ladder Accidents

Ladders may seem fairly simple to use. After all, all you have to do is climb u...


July 11, 2019

2019 Mercedes-Benz Seatback Failure Recall

Mercedes-Benz recalled 22,637 vehicles on February 26, 2019, because improperly...

Do I Have A Case?

We offer free consultation. No office visit required, we will get back to you within 24 hours.

  • This field is for validation purposes and should be left unchanged.

 

What can we do for you?

  • Answer your legal question.
  • Provide a Free Case Evaluation.
  • Schedule an appointment.

 

Why
Choose Us?

  • Available 24/7
  • Trusted Since 1990
  • Local to You
  • Recovered $350,000,000
  • 5 Star Reviews
  • Free Case Evaluation
  • VIP Service
  • No Win, No Fee

Latest Law Post


October 15, 2019

Zantac Recalled In All Markets

GlaxoSmithKline said on October 8, 2019 that it was recalling their popular heartburn medication Zantac in all markets as a precaution. This comes mere days after the U.S. Food and Drug Administration (FDA) found “unacceptable” levels of the carcinogen NDMA in the medicine.


October 2, 2019

Hidden FDA Database Concealed Reports of Surgical Stapler Malfunctions

A hidden FDA database of medical device failures was shut down in June 2019. The database contains medical device reports submitted to the FDA via its Alternative Summary Reporting Program from 1999 to 2019. Reports which were sent to this database were not, until recently, made public. The Alternative Summary Reporting Program is a non-public database, unlike the FDA’s MAUDE database which publicly logs medical device failures or defects for public review.

 

We are Personal Injury Lawyers representing accident victims throughout California.
For 30 years, the law firm of Nadrich & Cohen, LLP has helped injury victims
obtain the compensation they deserve.