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Johnson & Johnson/Ethicon Gynecare Transvaginal Mesh Injury

j&j/ethicon, transvaginal mesh complications lawsuits, mesh erosion
Melanie H. Muhlstock

Ethicon, a Johnson & Johnson Company, Makes Allegedly Dangerous Transvaginal Mesh Products

Johnson & Johnson's Ethicon division makes a number of transvaginal mesh devices, which are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Women who are implanted with these products are told that they will get relief for their conditions, but many say that the mesh only made their lives worse. One of the most common complaints, for instance, regards mesh erosion; this is when the mesh moves and cuts through the vaginal and pelvic tissues, causing immense pain. Surgery is performed to remove the mesh, but in some cases, scar tissue has already formed around the mesh, making it extremely difficult to remove. Some women needed multiple surgeries and still have not found relief.

Johnson & Johnson's Ethicon Stops Selling Four Transvaginal Mesh Devices

On June 4, 2012, it was revealed that Johnson & Johnson's Ethicon division would stop selling four types of transvaginal mesh implants. In a letter filed with the U.S. District Court for the Southern District of West Virginia, the company said it had asked the FDA for approval to stop selling the following devices:

  • Gynecare TVT Secur system
  • Gynecare Prosima
  • Gynecare Prolift
  • Gynecare Prolift + M

There is overwhelming evidence suggesting that transvaginal mesh devices are unsafe. For example, the FDA has reported a five-fold increase in injury reports related to the implants between 2008 and 2010. Despite the growing evidence, however, Ethicon and Johnson & Johnson claim that the decision to stop selling the mesh products had to do with commercial viability and not safety issues.

Type 2 diabetes drugs associated with adverse reactions Johnson & Johnson/Ethicon Gynecare Transvaginal Mesh Injury Parker | Waichman YouTube Videos

Jury Awards Woman $11.1 Million in Ethicon Vaginal Mesh Case Against Johnson & Johnson

In February 2013, Johnson & Johnson and Ethicon lost the first of some 4,000 Gynecare Prolift cases to go to trial. The jury awarded the plaintiff a total of $11.1 million; $3.35 million in compensation for her injuries, and $7.76 million in punitive damages against J&J.

Thousands of cases have been filed in the U.S. District Court for the Southern District of West Virginia over transvaginal mesh implants. So far, there are five multidistrict litigations (MDLs) pending in that court against Ethicon/Johnson & Johnson, Boston Scientific, C.R. Bard, American Medical Systems and Coloplast. Alleged injuries in these lawsuits include:

  • Additional surgery and multiple revision surgeries
  • Emotional distress
  • Loss of ability to have sexual relations
  • Loss of quality of life
  • Lost wages
  • Out-of-pocket medical, surgical and hospital expenses
  • Pain and suffering
  • Spousal loss of consortium

Safety Issues with Transvaginal Mesh

Studies reviewed by the FDA found that roughly 10 percent of women who undergo surgery with transvaginal mesh will suffer from mesh erosion within 12 months. Other complications linked to the mesh implants include:

  • Chronic vaginal damage, discharge and infections
  • Exposure or extrusion of mesh, where mesh moves through vaginal tissue
  • Feeling a lump in the opening or something protruding from the vagina
  • Painful sexual intercourse
  • Perforation of the bladder, intestines, bowels and blood vessels around the vaginal wall
  • Recurring POP
  • Recurring SUI
  • Urinary problems
  • Vaginal bleeding
  • Vaginal pain
  • Vaginal scarring and shortening

According to an FDA Safety Communication issued July 13, 2011, transvaginal mesh devices in general have been associated with serious complications. An expert advisory group convened by the FDA in September 2011 also expressed some concerns about the safety of transvaginal mesh.

A majority of the Obstetrics and Gynecology Medical Device advisory panel agreed that the safety, effectiveness, and benefits of transvaginal mesh devices in POP repair are not well established and needs to be followed up in the long term. The agency proposed reclassification of mesh devices that were used for POP repair to Class 3 from Class 2. This meant that surgical mesh designed for POP repair could no longer be approved via the FDA's lax 510(k) route, and manufacturers would need to do clinical tests to prove that their devices are safe and effective. This also meant that transvaginal mesh manufactured by Johnson & Johnson and other companies had not been clinically tested before being sold and implanted in thousands of women.

Parker | Waichman Logo Legal Help for Women Suffering from Transvaginal Mesh Complications
Our firm is representing numerous women in lawsuits over transvaginal mesh implants, including Ethicon transvaginal mesh products. To find out more about pursuing a lawsuit or to get free legal advice from one of our attorneys, please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) today.

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Johnson & Johnson/Ethicon Gynecare Transvaginal Mesh InjuryRSS Feed

Bellwether Case in Transvaginal Mesh Multidistrict Litigation Settled

Mar 13, 2015
Johnson & Johnson subsidiary Ethicon Inc. has settled a bellwether case in multidistrict litigation over transvaginal mesh injuries on the fifth day of the trial. Matthew Johnson, a spokesman for Ethicon, said the company and the plaintiff had reached a settlement to resolve her case, but he did not provide any details of the settlement, Law360 reports. In court documents, the woman alleged she suffered inflammation, chronic pain, and other complications because of the Ethicon...

Jury Awards $3.27 Million in Damages in Transvaginal Mesh Case

Sep 12, 2014
A West Virginia jury hit Johnson & Johnson subsidiary Ethicon Inc. with $3.27 million in damages in a product liability suit over Ethicon's transvaginal mesh sling. The jury found that Ethicon did not warn doctors and patients of the device’s potential risks. Law360 reports that the jury found in favor of the plaintiff on all counts, including strict liability, design defect, failure to warn and negligence. The jury did not award punitive damages. The plaintiff, Jo Huskey, sued...

Parker Waichman announces latest transvaginal mesh lawsuit filed

Nov 25, 2012
A Colorado woman is the latest to be represented by the national law firm of Parker Waichman LLP in a fight over the defective transvaginal mesh surgical devices manufactured and marketed by Johnson & Johnson  and Ethicon Inc. According to an announcent from the firm last week, the Plaintiff in Parker Waichman's latest filing to be added to the  In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327), a woman from Colorado was implanted with...

Mississippi Woman's Lawsuit Alleges Serious Injury Due to Transvaginal Mesh Products Manufactured by American Medical Systems, Johnson & Johnson

Aug 30, 2012 | Parker Waichman LLP
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a woman who was allegedly injured by three transvaginal mesh implants. The suit was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case 2:12-cv-03153) where it is one of many cases pending in the multidistrict litigation as part of the In Re: Ethicon, Inc. Pelvic ...

Georgia Womans Lawsuit Alleges J&J Transvaginal Mesh is Defective, Exposes Women to Risk of Mesh Erosion, Embedment

Aug 26, 2012 | Parker Waichman LLP
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a woman who was implanted with two transvaginal mesh products, the Gynecare Prolift Anterior Pelvic Repair System and the Gynecare TVT System. The suit, which was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03122), is one of the many cases that have...

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