A Female Surgical Nightmare

[Blackpool]

June 13, 2012

How a problematic medical device has escaped FDA regulation.

BY Lindsay Beyerstein

Years of activism have made women’s health a topic of everyday conversation. The mechanics of mammograms and the pros and cons of cervical cancer vaccines are familiar, but one common health problem that affects millions of women remains virtually unknown.

Time, gravity and childbirth can weaken a woman’s pelvic floor muscles and stretch out the ligaments that hold up her uterus, bladder and/or bowel, causing the organs to sag and bulge into the vagina—or even protrude from it—a disorder known as pelvic organ prolapse (POP). Up to half of all women will develop some degree of prolapse, and the diagnosis will become more common as the Baby Boomers age. One in 10 women suffering from prolapse will eventually need surgery to correct it, and every year about 300,000 women undergo prolapse surgery.

The symptoms depend on which organs are bulging and how much. A bladder bulging through the front wall of the vagina can cause incontinence, or difficulty voiding. A prolapsed rectum or small intestine can interfere with defecation. Women with prolapse may report pain during sex, a visible bulge, or a feeling like something is about to fall out of the vagina.

The condition can be debilitating and demoralizing—though rarely life-threatening. But for some patients, the cure can be worse than the disease...

...In medical and regulatory circles a controversy is raging over the use of non-absorbable mesh for the transvaginal repair of pelvic organ prolapse...

...But since the early aughts, mesh for transvaginal prolapse repair has been increasingly sold in kits, which typically contain pre-cut pieces of mesh and long needles to push the mesh deep into the pelvis and anchor it to the pelvic floor. These kits have opened up POP surgery to much less experienced surgeons.

Kits are also profitable for device manufacturers. In 2010, 79,500 mesh kits were sold in the United States. A single kit of sterile mesh and disposable instruments—cheap raw materials—yields a healthy profit margin when sold for $2,000 apiece. About 20 POP mesh products are cleared for sale and actively marketed in the United States.

Unfortunately, the boom in transvaginal mesh kits may be based on a defective surgical theory...

http://www.inthesetimes.com/article/1335...nightmare/

[tonysam]

The "golden years" my ass. Much of this stuff is age-related.

[Arg U Mentor]

Y'know, I know there's like a four paragraph limit, but it doesn't have to be the first four. Try putting the one's that are important, fcs.

'Unfortunately, the boom in transvaginal mesh kits may be based on a defective surgical theory. Tom Margolis, a Bay Area pelvic surgeon who specializes in removing mesh, paid his own way to testify before an FDA meeting last September. He testified that the use of synthetic mesh for transvaginal repair of pelvic organ prolapse contradicts core principles of surgery. The vagina is a clean-contaminated surgical field, which means that unlike the skin of the abdomen, it can’t be fully disinfected before surgery. Infection is a risk for any type of implantable device. Passing a porous mesh through a contaminated field is an invitation to infection. Margolis says transvaginal mesh violates the Golden Rule of Surgery: “You shall never implant a synthetic object into anyone’s body, anywhere, if it’s contaminated.”

All surgery for pelvic organ prolapse has risks. However, mesh has a unique risk of complications due to a phenomenon known as “erosion.” Within a year, in about 10 percent of patients, the mesh can work its way to the surface of the vagina, or '

Now I see that this article is WAY important, not about how some of us are lazy and forget to attend the strength of our abdominal and genital muscles and have surgery instead, but about the DANGERS of some of those surgeries that put the surgical support through the impossible-to-sterilize-vagina.

[Blackpool]

(06-15-2012 11:28 AM)Arg U Mentor Wrote:  Y'know, I know there's like a four paragraph limit, but it doesn't have to be the first four. Try putting the one's that are important, fcs.

'Unfortunately, the boom in transvaginal mesh kits may be based on a defective surgical theory. Tom Margolis, a Bay Area pelvic surgeon who specializes in removing mesh, paid his own way to testify before an FDA meeting last September. He testified that the use of synthetic mesh for transvaginal repair of pelvic organ prolapse contradicts core principles of surgery. The vagina is a clean-contaminated surgical field, which means that unlike the skin of the abdomen, it can’t be fully disinfected before surgery. Infection is a risk for any type of implantable device. Passing a porous mesh through a contaminated field is an invitation to infection. Margolis says transvaginal mesh violates the Golden Rule of Surgery: “You shall never implant a synthetic object into anyone’s body, anywhere, if it’s contaminated.”

All surgery for pelvic organ prolapse has risks. However, mesh has a unique risk of complications due to a phenomenon known as “erosion.” Within a year, in about 10 percent of patients, the mesh can work its way to the surface of the vagina, or '

Now I see that this article is WAY important, not about how some of us are lazy and forget to attend the strength of our abdominal and genital muscles and have surgery instead, but about the DANGERS of some of those surgeries that put the surgical support through the impossible-to-sterilize-vagina.

Wow, what a shitty remark.

[Arg U Mentor]

Appropriate though for a shittily prepared OP.

[Blackpool]

(06-15-2012 11:23 PM)Arg U Mentor Wrote:  Appropriate though for a shittily prepared OP.

You know, I came here to get away from DU arrogance. Apparently, you can't.

Congratulations. I'm doing something I never thought I'd do on OET, your're going on ignore.

Don't bother to respond. Unless your ego can't stop you...