Johnson & Johnson subsidiary Ethicon Inc. has begun a phased withdrawal of four of its vaginal mesh products for treating pelvic organ prolapse and stress urinary incontinence with the goal of completing the process by the first quarter of 2013.

The action comes after FDA issued requirements in January for manufacturers to conduct post-market studies of such products to reassess their safety and efficacy. (See Also see "Surgical Mesh And Sling Devices Must Undergo Post-Market Studies" - Medtech Insight, 9 January, 2012..) This followed an advisory panel meeting and an FDA safety notification reporting approximately 1,500 adverse events related to vaginal mesh for prolapse repair between 2008-2010. (See Also see "FDA Panel: Transvaginal Mesh For Prolapse Should Be Class III" - Medtech Insight, 12 September, 2011..)

Ethicon informed FDA May 10 that it is stopping sales of the devices over the next three to six months on a region-by-region basis. The firm has also informed regulatory agencies worldwide, Matthew Johnson, an Ethicon spokesperson, told “The Gray Sheet.”

“I would like to stress that this is not a product recall and we continue to have confidence in the safety and efficacy of these products,” Johnson said in a written statement. “Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”

In addition to “competitive and declining worldwide markets,” the firm cited as reasons for the market withdrawal “the complexities of the regulatory environments in which we operate and the availability of other treatment options for women.”

Alternatives to vaginal mesh for prolapse repair include surgical native tissue repair of the vaginal wall (colporrhaphy), and sacral colpopexy, which is surgical repair via incisions in the abdomen.

Over 1,000 suits have been filed against Ethicon related to injuries allegedly caused by the firm’s vaginal mesh products for prolapse repair and stress urinary incontinence, according to plaintiffs’ attorneys.

The discontinued products include Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M pelvic floor repair systems to treat prolapse, as well as Gynecare TVT Secur to treat stress urinary incontinence. The firm is not recommending that patients have the implants removed.

Ethicon will keep its Gynemesh PS on the market, but will pursue FDA approval to change the indication to specify abdominal (open or laparoscopic) use only. Currently, it is indicated for vaginal and abdominal use. The firm says it is still awaiting a response from FDA on its request.

Ethicon is also keeping the remainder of its mesh products for urinary incontinence on the market, including Gynecare TVT Abbrevo and Gynecare TVT Exact, as well as Gynecare TVT systems for both retropubic use and obturator use, Johnson said.

Liability Suits On The Rise

In the past year more than 3,000 product liability lawsuits have been filed in federal and state courts against the primary manufacturers of mesh products, including Ethicon, C.R. Bard, Boston Scientific and Endo Pharmaceuticals/American Medical Systems. Of the total, more than 1,000 have been filed against Ethicon relating to their vaginal mesh products, plaintiffs’ attorneys say.

Approximately 2,000 of the cases have been consolidated into multidistrict litigation in the Southern District of West Virginia federal court. Of those, there are about 400 Ethicon cases, as of the week of June 4, according to Lexi Hazam, a partner at Lieff Cabraser Heimann & Bernstein in San Francisco. There also have been about 850 cases filed against Ethicon in New Jersey State Court as of June 4, the plaintiffs’ attorney said.

Attorneys representing women who have filed the personal injury lawsuits against the firms anticipate that the number of lawsuits will continue to increase.

“Now that some of these products are being withdrawn from the market, that will raise awareness among doctors and patients regarding the problems women are having with vaginal mesh generally, and this may result in additional claims,” said Hazam, who is representing dozens of clients in personal injury lawsuits against Ethicon, as well as the other manufacturers. J&J agrees that more cases likely will be filed.

In an April Q-10 filing with the Securities & Exchange Commission, J&J said that the number of pending product liability lawsuits against the firm relating to pelvic mesh devices for pelvic organ prolapse and stress urinary incontinence “continues to increase, and the company continues to receive information with respect to potential costs and the anticipated number of cases.” The firm notes it has established a “product liability accrual” in response to the litigation.

Responding to J&J’s market withdrawal, Hazam said she is pleased, claiming the devices are unsafe. “We were glad to see that these unsafe products will no longer be sold and that women will no longer be harmed by them in the future,” she said. “Of course, women who have already been harmed by them should receive fair compensation for their injuries from this company that placed unsafe products on the market.”

“Regardless of what J&J has said regarding the withdrawal,” Hazam continued, “we believe that safety reasons also mandate withdrawing this product, based on the FDA report last summer, and based on what we’ve seen with our clients and the evidence obtained to date in the litigation.”

Competitors React

In the wake of the J&J withdrawal, competitors Endo/American Medical Systems and Boston Scientific say that they are keeping their vaginal mesh products for prolapse and urinary incontinence on the market. C.R. Bard did not respond for comment by press time.

“AMS remains committed to its pelvic organ prolapse and stress urinary incontinence lines as safe and effective treatment options for patients suffering from these debilitating conditions,” Endo/AMS said in a June 6 statement. The firm notes it is continuing to work with FDA to conduct Section 522 post-market studies of the devices, as required by FDA earlier this year.

Boston Scientific says it is also working with FDA to “ensure that the appropriate information, including new and additional information, is provided to physicians and patients” relating to their mesh products.

Denmark-based Coloplast also is conducting Section 522 post-market studies for three of its vaginal mesh products for prolapse repair that are sold in the U.S., including Restorelle polypropylene mesh, Novasilk polypropylene mesh and the Exair Prolapse Repair System.

Meanwhile, Ethicon’s Johnson says the company is discussing with FDA whether it will be required to conduct Section 522 post-market studies for the four vaginal mesh products it plans to withdraw. Nevertheless, J&J says it plans to support ongoing randomized trials through to completion for two of the discontinued products, Gynecare Prolift and Gynecare Prolift+M.

J&J/Ethicon Begins Worldwide Withdrawal Of Vaginal Mesh Products

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