Personal Injury Law

Lawsuit: Mentor Mesh For Urinary Incontinence

By Jane Akre

Mentor Mesh For Urinary Incontinence

Amber Suriani liked what she heard. Turning 40 and suffering the inconvenience of a light case of urinary incontinence, she liked hearing there was a quick fix - a sling would be placed under her urethra and she would be back to practicing karate the same week. 

It sounded good. Too good.

First there was the painful, bloody discharge that began several months later. Today she relies on Motrin to get through the day. Five operations to remove the surgical mesh that had worked its way through her vaginal wall, and it's still not out.

The Food and Drug Administration in a Public Health Notification issued last October, said it had received more than 1,000 reports concerning nine surgical mesh devices, including complications such as bowl and bladder perforations, infection, pain and mesh erosion.

Doctors are told to warn patients that surgical mesh may be permanent.    

An attorney working for Mentor, John Q. Lewis, with Jones Day, tells the New York Times that doctors should warn patients there are risks with any surgical procedure.

"It's very unfortunate when anyone reports a complication," he says, "that being said, these are complications that are well known, that patients are warned about, and are inherent to a surgical procedure that has helped thousands and thousands of people live a better life.   

He tells the Times, "The overall benefits of the procedure and this product outweighed the potential risks."

It's estimated 35,000 women were treated with the Mentor sling during the three years it was on the market. 

The Problem

In January, IB News reported 32 lawsuits have been filed with the Mentor Corporation of Santa Barbara, California over ObTape.

Attorneys argue that the Mentor sling has nonporous fibers that block vital nutrients and oxygen from reaching the tissue and prevent healing. That defect also is alleged to cause the device to push through the vaginal wall.

Lana Keeton, founder of the patient advocacy group, Truth in Medicine, says she compared the ObTape to other synthetic surgical mesh made of prolene, which is also synthetic and petroleum-based.

"It looks like a heavy white athletic sock and prolene looks like a sheer stocking of nylon" she says.   

But the heavier, dense material of the ObTape may have added to its demise.  Too dense to allow tissue and capillaries to incorporate it in the body, instead it became encapsulated and expelled, say the experts, reports the New York Times.  

Mentor was removed from the market after a Journal of Urology study documented widespread injuries suffered by women with the Mentor ObTape.

Its 2005 successor, the Aris Mentor, is also made of synthetic petroleum-based mesh, but is much lighter.   

Mentor, newly acquired by Johnson & Johnson, is known for its "body aesthetics" line of breast implants.

Removed From The Market

Truth in Medicine, an advocacy group, is gathering names of men and women injured by all synthetic surgical mesh used for vaginal slings and hernias. The world-wide registry will be sent to Congress to have the synthetic, petroleum-based slings and mesh removed from the market. 

IBNews explains in Part 3 of Suffering in Silence From A Medical Device - Surgical Mesh, how many  medical devices, including mesh, tape, and slings, are cleared for marketing but do not undergo the more rigorous premarket approval process.

Instead they need only claim "substantially equivalence" to a device already on the market.

Diana Zuckerman, of the nonprofit National Research Center for Women & Families, testified about medical devices before a House Subcommittee on Energy and Commerce in 2007 said every American uses medical devices and all should be concerned about the approval process.

"More than 5,000 medical devices were approved by the FDA last year. Almost all (98%) were cleared through a "quick and easy" process that usually does not require clinical trials to prove that these medical devices are safe or effective. As a result, some of these devices are neither safe nor effective.   Are medical devices "proven safe and effective"? Not usually."  #

Full post as published by InjuryBoard on May 06, 2009 (boomark / email).