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CBS4 I-Team: Medical Device Disintegrated In Women
MIAMI (CBS4) ―
A device designed to correct an embarrassing medical condition has become a nightmare for some women. An estimated 35,000 women were implanted with the device. Now, some are coming forward claiming it deteriorated inside their bodies and has made their lives miserable.
CBS4 Investigative Reporter Laurie Stein spoke exclusively with Betty Mosher, a woman who has filed a lawsuit against the company that sold the product.
When Mosher was 43, she suffered from an embarrassing medical problem and kept it secret because she didn't want anyone to know about it.
Only now is she able to talk about the problem called "urinary stress incontinence." It means, "I couldn't control the urine flow and that's embarrassing," said Mosher.
It might surprise you to hear that 2 million women in the United States reportedly have this disorder.
For Betty, it all started after delivering two children. By the time they were teenagers, the physical affects were much more severe.
When her doctor said a new product, made by the Mentor Corporation, could help she agreed right away. It was called Obtape, a catchy name for a piece of mesh that sort of acts as a "sling" and tapes up the bladder to stop it from leaking.
"When you heard there might be a solution to your problem, how were you feeling about that idea," asked Stein.
"Ecstatic! I was so excited. I was just like you get to be back to a regular person," said Mosher.
Within months, she says the tape had moved out of place and started to disintegrate inside her. She started to get sick. Doctors removed the sling, piece by piece, and left a huge wound in her leg. T
he CBS4 I-Team learned that Betty isn't the only one with a difficult story to tell about Mentor's Obtape. There's a medical study that examined 67 patients and more than 13 percent had similar complications.
Doctors say many slings are safe, but they must be tested thoroughly.
Dr. Jaime Sepulveda is a national expert in what the medical community calls pelvic floor medicine. He told the I-Team he was always skeptical about Mentor's Obtape, because unlike similar products on the market, it had different dimensions and hole sizes. He said it never should have been approved by the Food and Drug Administration.
In fact, the CBS4 I-Team learned that there are now several lawsuits against the Mentor Corporation as more women come forward claiming that Obtape migrated inside their bodies, disintegrated, and had to be removed surgically.
Laurie Stein spoke with a Mentor attorney who claims Betty's problems had nothing to do with Obtape and that Mentor "stands behind the product".
Attorney Gary Blasingame, who represents Betty and other Obtape patients, thinks Mentor misled the FDA when it applied for what's called 510K status, which means it claimed that its product was so similar to ones already on the market it didn't need complete testing.
"The FDA wasn't watching carefully enough," said Blasingame.
An FDA representative would not comment on Mentor's sling or the lawsuits but did tell the I-Team, "the FDA approval process is the gold standard for the rest of the world and that it makes sure all products are safe and effective before they get approval."
Mentor no longer makes Obtape.
(© MMIX, CBS Broadcasting Inc. All Rights Reserved.)
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