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Mentor ObTape The Focus Of Growing Number of Lawsuits

Posted by Jane Akre
Wednesday, January 07, 2009 12:01 PM EST
Category: Major Medical
Tags: Women's Health, Medical Devices, FDA and Prescription Drugs, Mentor Corp., urinary Incontinence, vaginal sling, ObTape, surgical mesh

Mentor ObTape the focus of a growing number of lawsuits.


IMAGE SOURCE: ©iStockphoto/ woman suffering pain/ author: Peepo

So far 32 lawsuits have been filed against the Mentor Corporation of Santa Barbara, California, with more in the pipeline over its withdrawn medical device ObTape.

ObTape was used to treat urinary incontinence that occurs after childbirth, which causes urine to leak when the woman coughs, sneezes, laughs, or exercises. Mentor stopped making ObTape in 2006.

Surgical mesh devices in general have been linked to infection, pain, erosion of pelvic organs, and scarring by the Food and Drug Administration, which issued a Public Health Notification in October.

The FDA reports that over the past three years it has received over 1,000 reports from manufacturers of the device about complications.

The Mentor sling was introduced in 2003, but pulled from the market in three years. It’s estimated 35,000 women were treated with the Mentor sling before it was withdrawn.

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.

Mentor was removed from the market after a Journal of Urology study documented widespread injuries suffered by women with the Mentor ObTape, while no complications were experienced by a sling from another manufacturer.

Mentor is enjoying a recent court verdict in California where a jury ruled against a plaintiff’s claims.

In that case, Lisa Ann Seeno sued Mentor charging the company was negligent in designing the product and that the company failed to warn about its dangers.

Jurors decided that the doctors knew about the surgical mesh risks.

So far 22 of the cases have been consolidated in multidistrict litigation (MDL) in the Middle District of Georgia. Gary Blasingame, an attorney from Athens, Georgia, is handling the bulk of the ObTape cases which cover plaintiffs in California, Florida, Georgia, Louisiana, Missouri, New Jersey, New York, Ohio and Oklahoma.

He predicts more cases will come, despite the loss of the first case.

The Mentor Company is known for its “body aesthetics” line of breast implants.

Last month, Johnson & Johnson agreed to acquire Mentor for $1.07 billion in a cash tender offer. It will report to ETHICO Inc, a J & J company which produces sutures and mesh for surgical procedures. #

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