Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, May 5, 2014

San Antonio, TX: Women harmed by implanted surgical mesh

by Deborah Knapp / KENS 5

Posted on May 1, 2014 at 9:52 PM
 Follow link above to watch the video.  FiDA highlight

SAN ANTONIO -- More than 20 million women in the United States have urinary incontinence.  Yet, the topic is often taboo.
A device that was supposed to help the condition is now at the center of thousands of lawsuits from women who say it's ruined their lives.
Jennifer Ramirez is one of those women who says she is in constant pain after receiving a mesh implant that was supposed to cure incontinence.
In Ramirez's case, she didn't even have a serious condition, it was used to prevent it from developing further.
"I have pelvic pain, constant pelvic pain," said Ramirez.
 Life is also painful for 64-year-old Linda Batiste.
The condition that brings both women to tears is embarrassing to discuss.
"It actually does feel like a scouring pad in your body.  You can feel in your women parts, what it is.  It's there," said Batiste.
That feeling comes from a product left inside her body to fix urinary incontinence.
In thousands of cases, including Batiste and Ramirez, doctors use a pliable, gauze-like mesh sling to support the bladder and other organs.
But, what the women got was not relief.
"I have never been pain-free, since then," said Batiste.
After the birth of her third child, Ramirez underwent a hysterectomy and then got the mesh sling.
"I had it as a precautionary when I had my hysterectomy because I had some stress incontinence from coughing or sneezing or jumping on a trampoline," said Ramirez.
The pain forced her to have the device removed just months later. 
"Now my life has to revolve around having a restroom right there because when you have to go you have to go or you will have an accident. It's embarrassing and depressing," said Ramirez.
Other complications from mesh implants develop when it becomes embedded in organs and it can make sexual intimacy painful.
"The polypropylene mesh, it degrades, it disintegrates, it extrudes, it frays, it ropes and it has particle loss.  And all of those problems cause other problems. like scarring, chronic pain, for example," said Tim Goss who represented Batiste in a product liability case against the Johnson & Johnson subsidiary Ethicon.
Surgical mesh is a synthetic material. 
It's manufactured by several companies and routinely used for urinary incontinence, pelvic prolapse and hernia operations. 
The American Urogynecologic Society said it's "safe, effective, and has improved the quality of life for millions."
The FDA first issued a "Public Health Notification" in 2008, saying it had received "over 1,000" reports of "adverse events" "for surgical mesh devices"
In 2011, The FDA sent out another warning, saying "serious complications associated with surgical mesh" "are not rare."  and that mesh "may expose patients to greater risk" than traditional procedures.
Since then, women across the country have formed organizations and online support groups, trying to get mesh removed from the market.
Linda Batiste just won a $1.2 million verdict against the maker of her mesh in the first case of its kind in the nation to go before a jury.
"It's significant because there are almost 100,000 other cases pending around the country regarding this type of product," said Goss.
Goss, who represents 9,000 mesh cases himself including Jennifer Ramirez's, says the lawsuits have the potential to become the largest mass-tort in history, bigger - even - than the phen-fen diet drug mess.
Linda Batiste has had several surgeries to try to removed the mesh, which is embedded in her tissue.
And, her original problem of incontinence is back.
"And it's compounded the pain that I normally would have had.  I never wish for any other woman to feel this way or to have it happen to them, " said Batiste.
Tuesday, the FDA announced it wants stricter safety rules for the mesh implants.
It is proposing labeling the female incontinence device as "high risk"  after years of reports of pain among women who have received the implants.
Right now there are more than 100,000 cases in the U.S. pending against the makers of the mesh. 

The attorney we spoke to said since the mesh implants are still being used, he expects that number to increase.

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