Saturday, September 25, 2010

Vaginal Prolapse for women

Perspectives on surgery for vaginal prolapse: Dr. W. Allen Addison


Reuters news, Mesh Prone to erosion http://www.thedoctorschannel.com/video/3490.html


Readers Digest  http://www.rd.com/living-healthy/medical-devices-that-can-kill/article184371-1.html
Lana Keeton lives in pain because of a different hole in the regulatory safety net. In 2001, she was scheduled for a hysterectomy because fibroids—benign tumors in her uterus—were causing bleeding and cramping. A few days before the surgery, she mentioned to her surgeon that she leaked a small amount of urine when she coughed or sneezed. No problem, the doctor said; he could fix that at the same time. To do so, he'd use a sling made out of synthetic mesh to support her bladder. What the doctor did not tell Keeton (and probably did not know himself) was that the mesh he planned to use had been approved thanks to its similarity to an older product, Boston Scientific's ProtoGen—which was recalled in 1999.


Synthetic surgical mesh is used in thousands of surgeries each year to patch holes in the abdominal wall during a hernia repair, for example, or prop up sagging organs like the uterus or bladder. But it turns out that something about mesh can make it a hospitable environment for germs. Three days after Keeton's operation, she was rushed to the hospital with a life-threatening infection known as necrotizing fasciitis—flesh-eating bacteria.

Keeton needed emergency surgery to cut away infected tissue. She spent 16 harrowing days in the hospital and was bed-bound for another three months. Then, after her wound had closed, the mesh began eroding through the wall of her bladder like a grater through cheese. "The pain was so bad that it woke me up even when I was on a morphine drip," says Keeton, who has had 16 surgeries and procedures to repair the damage. Unable to work and facing a mountain of medical bills, she lost her home and was forced to declare bankruptcy. "Nobody should have to go through what I've had to," she says.




In 2008, the FDA issued an advisory: It had received more than 1,000 reports of infection, erosion, and other problems involving many brands of mesh. But the agency's action came years later than it should have, according to Diana Zuckerman. When ProtoGen mesh was recalled in 1999, Zuckerman says, the agency should have investigated all mesh products based on it, and doctors and patients should have been informed.



The consequences of the FDA's silence have been devastating. Published studies have reported problems that include bowel perforation, bleeding, and even death. Granted, those complications are rare. But, says Donald Ostergard, MD, past president of the American Urogynecologic Society, the FDA approval process for mesh "is inadequate to protect the public from what I consider to be a public health hazard."


Says Zuckerman, "You have all these women who started out with a relatively small problem with stress incontinence when they exercised or sneezed, and now they can't work, can't sit, can't have sex. When mesh goes bad, it's a disaster."

http://www.wellsphere.com/general-medicine-article/serious-complications-with-surgical-mesh-used-in-bladder-suspension-surgery/436950

2 comments:

travelady said...

Kathy what are your plans??? This is scary stuff.... xoxox

Christine Montgomery said...

I read her story and I was shocked to hear about her ordeal. There are also some shocking photos at her blog, which clearly proves how horrible a mesh complication can be. Its clear that the pelvic mesh implants holds serious risks and more then a few FDA warnings are needed for women to be aware of the issue. The problematic products seems to be the mesh implants used for pelvic organ prolapse but the bladder sling devices used for SUI repair can cause excruciating pain.