gynecology

RECENT POSTS

Consumer Advocates: FDA’s Action On Vaginal Mesh ‘Too Little Too Late’

Public Citizen, the consumer advocacy group that years ago called for tighter restrictions on a type of surgical mesh used to treat pelvic organ prolapse, called the FDA’s latest proposal to increase oversight on the products “troubling both in its scope and timing.”

The group said in a statement that the government agency waited too long to act and that its recommendations may still put women at risk.

Here’s the full statement from Public Citizen’s Health Research Group Director Michael Carome on the FDA’s latest proposal:

Public Citizen welcomes…[the] long-overdue issuance of a proposed order by the U.S. Food and Drug Administration (FDA) that, if finalized, would reclassify surgical mesh for transvaginal pelvic repair organ prolapse (POP) from a moderate-risk device (class II) to a high-risk device (class III). This would subject these devices to a more rigorous approval process that would require manufacturers to submit to the agency premarket approval applications with evidence from clinical trials that the devices are safe and effective. Such an order would implement one of three actions requested in Public Citizen’s August 25, 2011, petition to the FDA, which also requested an immediate ban and recall of all such devices currently on the market.

(wikimedia commons)

(wikimedia commons)

However, the FDA’s action today is troubling both in its scope and timing. First, the agency acknowledged that the safety and effectiveness of surgical mesh for transvaginal repair of POP has not been established and that these devices frequently cause serious adverse events. But the agency has taken no action to immediately remove currently available products from the market, as we requested in our petition, or to warn physicians and patients to stop using these devices.

Second, it is disturbing that the agency has taken so long to begin the regulatory process to reclassify surgical mesh for transvaginal repair of POP Continue reading

FDA Proposes New Restrictions To Address ‘Health Risks’ Of Vaginal Mesh

The U.S. Food and Drug Administration today proposed strict new regulations to address the “clear risks” associated with surgical mesh used to treat vaginal prolapse in women.

Specifically, federal regulators want to reclassify surgical mesh as a “high-risk” medical device (it’s now in the “moderate-risk” category) and also impose more requirements on manufacturers in which they must demonstrate that the device is safe and effective.

The risks and health problems related to this type of surgical mesh, which we’ve detailed here, include infections and nerve damage that can occur when the material erodes through the vaginal lining, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and an end to a women’s sex life.

Here’s the full FDA news release:

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” Continue reading

Why The IUD Is On The Rise (And You Might Want One)

http://www.youtube.com/watch?v=-2oMElDcpdM

(Above: A 7-minute IUD show-and-tell by a leading expert, Dr. Eve Espey)

Full disclosure: I had an intra-uterine device implanted soon after my second child was born, and in my own experience, using an IUD for birth control is something like what Churchill said about democracy: It’s the worst system around — except for all the other ones.

My first few months with a Mirena — an IUD that emits tiny levels of the hormone levonorgestrel — were rife with unpredictable spotting. That certainly got very old very fast. But then the spotting ended, and my periods blessedly all but disappeared, a common Mirena effect. It’s been nearly seven years now, and I’ve been both problem- and pregnancy-free. I even re-upped for a second device when the first one hit its five-year limit.

So that’s my bias when I report that in recent weeks, I’ve noted a striking convergence of signs pointing to a new era of far greater popularity for IUDs. There’s even talk of an IUD “renaissance” — once all but unthinkable after the debacle of a 1970s device called the Dalkon Shield.

The "Mirena" hormone-releasing IUD

In the not-too-distant future, getting an IUD, which costs several hundred dollars, will be universally covered and co-pay-free under new federal insurance rules. The latest numbers suggest IUD use among American women has risen dramatically in the last decade. And the IUD’s safety record is looking so good that recent research finds that the devices can even be implanted right after an abortion or a birth.

“The message is finally getting out there that IUDs are a great option — that they’re highly effective, that they’re long-acting, and they provide reversible, highly effective contraception with just one act,” said Dr. Alisa Goldberg, director of clinical research and training at the Planned Parenthood League of Massachusetts. (That “one act” is having the IUD implanted, a quick office procedure.)

Among the first 2500 women who enrolled in the study, 56% — that’s right, more than half — chose to get IUDs.

“And the message is finally getting out there that the old days — the days of the Dalkon Shield — are long behind us,” Alisa, who’s also director of the division of family planning at Brigham and Women’s Hospital, said. “There are increasing amounts of data showing the safety, the efficacy and the increasing popularity of these methods.”

In a country where nearly half of pregnancies are accidental, “This could have a huge impact on public health,” she said.

No, she’s not in the pay of the IUD makers. She sounds just like many other evidence-based experts on contraception who have been pushing for greater IUD use for years. In fact, it was because I’d read some of their research that I opted for an IUD seven years ago, despite a lingering sense of past disaster.

Now the factors in the IUD’s favor are visibly multiplying. Most recently, new federal rules announced earlier this week, requiring insurers to cover women’s contraception without co-pays, will remove the upfront costs that put many women off IUDs. Continue reading

Special Report: My Quest For Pain-Free Sex, Part II

“Does your pain occur with ‘deep penetration’ or is it more like a ‘ring of fire,’ at the opening?”

This is the kind of question you get upon entering the world of pelvic floor physical therapy. That is, if you’re lucky enough to find out that the therapy even exists.

Recently, I wrote about my experience suffering from pain during sex, and how I found relief from pelvic floor physical therapy, a little-known treatment that is often overlooked by doctors. I got scores of comments from other women with similar problems — some who have lived with their pain for years. Like me, they’d never heard of pelvic floor PT, and they were thrilled to learn that there is an effective alternative to quietly enduring their extreme, often secret, discomfort.

Perhaps pelvic floor therapy might soon gain credibility: last week, a local physical therapist, Jessica McKinney, used my story as part of her Grand Rounds at Massachusetts General Hospital. She spoke to about 16 obstetrician and gynecology residents and medical students. They listened intently to her hour-long talk (edited and posted below) and when it was done, one young man walked over and asked, “What’s a Kegel?”

Pelvic floor PT is far more than Kegel exercises. So, in the spirit of enlightenment, here are a few more details (maybe too many) about my sessions at the Brigham and Women’s Hospital Department of Rehabilitation Services:

The First Visit

After my physical therapist, Rachael Maiocco, talked about the anatomy of the pelvis and relevant organs, she asked many questions about the nature of my pain. Was it deep or superficial? How intense on a 1-10 scale? Continue reading