Vaginal Mesh Lawsuits Guide

American Medical Systems

1,264 pending lawsuits

21,180 total lawsuits

Boston Scientific

8,603 pending lawsuits

24,334 total lawsuits

Coloplast

145 pending lawsuits

2,620 total lawsuits

Cook Medical

186 pending lawsuits

635 total lawsuits

C.R. Bard

3,621 pending lawsuits

15,568 total lawsuits

Ethicon

26,393 pending lawsuits

39,442 total lawsuits

ObTape

A total of 867 lawsuits were filed in this action between 2008 and 2017, though the judge asked the JPML to stop adding cases.

He stated that too many cases did not have enough evidence or that they were barred by the statute of limitations (the filing window). However, the MDL has not been closed, and six cases are pending. Women can also choose to file claims against ObTape in state court.

Boston Scientific

ProteGen Sling

This is the big one, the mother of them all - the mesh monster from which all other mesh monsters were spawned. This product was cleared for sale in 1996 for stress urinary incontinence (SUI) surgeries.

It only took months before patients began reporting serious post-surgical complications. The product was voluntarily recalled in 1999, only three years after it was introduced.

The ProteGen Sling was the model for a number of similar products, and because there was a "substantially similar" product already on the market, they were approved without premarket testing. That led to hundreds of thousands of additional lawsuits against various companies, many of which still have products available.

Mentor

ObTape vaginal sling

Discontinued in 2007, though they did not pull devices that were still available on the market. They continued to be used in pelvic surgeries.

C.R. Bard

Avaulta Plus, Pelvilace, Uretex

Withdrew a few of their products after there were calls for more clinical testing.

Ethicon

Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secur, Gynecare Prosima , Pelvic Floor Repair System Kit

This division of Johnson & Johnson took 4 of its Gynecare products off the market, though they claimed it was not because of safety concerns.

They actually still sell some Gynecare devices, though they changed the labels so they are indicated for transabdominal insertion, not transvaginal.

The Gynecare TVT Secur was only tested on sheep and 31 human women for five weeks before mass distribution.

Endo and subsidiary American Medical System (AMS)

Apogee Vaginal Vault Prolapse Repair System, Perigee Transobturator Anterior Prolapse Repair System, Elevate

This medical device manufacturer closed their Astora Women's Health division in 2016, which made their transvaginal mesh products. This was because the company had to devote billions of dollars to transvaginal mesh lawsuits. It also sold its subsidiary AMS, which produced transvaginal mesh products that were the subject of 22,000+ lawsuits, to Boston Scientific.

January 6, 2017

Surgical tools are reclassified to Class 2, which means that device manufacturers must provide premarket notification to the FDA before selling the instruments.

February 26, 2016

The FDA convenes a panel to discuss the reclassification of surgical tools used in mesh surgeries.

January 5, 2016

Transvaginal mesh devices are placed in Class 3 and now require premarket approval.

May 1, 2014

The FDA proposed changing the device from Class 2 to Class 3, along with reclassifying the accompanying surgical tools from Class 1 to Class 2.

July 13, 2011

The FDA issued an update to their 2008 notification. This stated that "complications associated with transvaginal repair of POP are not rare." They also said that these implants are a greater risk for POP patients than non-mesh surgeries. They could not even say whether mesh surgeries were more effective.

October 20, 2008

The FDA issues a Public Health Notification to doctors regarding the potential risks of transvaginal mesh when used in pelvic surgeries. In two years, they received more than 1,000 reports of complication in POP and SUI patients.