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$830M Settlement Announced in 20,000 Transvaginal Mesh Cases

Endo International, the parent company of American Medical Systems (AMS), has agreed to an $830 million settlement of some 20,000 lawsuits over its transvaginal mesh products.

The products in question include the Perigee, Apogee and Elevate implants. The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston).

Endo and AMS are just two of a number of large transvaginal mesh device makers that are facing what The New York Times described as tens of thousands of lawsuits over mesh devices. The devices are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina.

The injuries that women are suffering from this mesh implant are severe and debilitating. The edges of the mesh/sling cut through the skin after implantation causing infection and cutting into nearby structures sometimes puncturing the bladder, bowel and uterus.

Additionally, petroleum based synthetic material is particularly capable of causing infection because the material itself is a "breeding ground" for bacteria.  Complications from these infections include incontinence, extreme pain during intercourse, UTI, back pain, inability to walk, etc.  Some of these infections spread through the whole body and lead to death.

In 2013, Endo agreed to pay $54.5 million to settle an undisclosed number of similar cases, according to The New York Times and, at least 5,000 more claims against AMS remain open; some have been consolidated for pretrial proceedings in West Virginia, court records indicate. (MDL 2325 American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation, United States District Court, Southern District of West Virginia)

FDA increases safety mandates

Endo’s settlement announcement came just after the U.S. Food and Drug Administration (FDA) announced that the vaginal mesh devices should have increased safety mandates given that they are considered, but have not yet been classified, as high-risk medical devices.

“This is only the first step in what we hope will provide closure to thousands of women who are experiencing lifelong, debilitating pain and suffering including, but not limited to, recurrent bladder and/or urinary tract infections; severe pelvic pain; and, in some instances, urinary incontinence, as a result of being implanted with these devices,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP.

“We continue to represent many women who have filed lawsuits over alleged injuries associated with Endo, AMS, and other transvaginal mesh manufacturers and continue to provide free legal advice for anyone who seeks more information about their rights.”

Parker Waichman is a national law firm dedicated to protecting the rights of victims injured by defective medical devices has filed a number of lawsuits. These include:

  • American Medical Systems (In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325)
  • Boston Scientific (In Re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation, MDL No. 2326)
  • Johnson & Johnson (In Re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2327).

Judge Joseph Goodwin is overseeing these MDLs in the U.S. District Court for the Southern District of West Virginia.

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