Recent FDA warning on mesh surgery for pelvic prolapse ---- support that women need to make informed decisions

"Thank you for helping women get better care. This was the second mesh warning to come from the FDA; we saw little change after the first warning was issued in Oct 2008. The influence of industry on patient care continues to amaze. Thanks again."

-- Peggy Norton, M.D.
University of Utah Health Care
University Hospital

July 2011-- From Winnifred Cutler, Ph.D.
“This month I received an update from the American College of Obstetrics and Gynecology (ACOG) announcing their shared concern with the FDA's recent study reporting complications in the transvaginal placement of surgical mesh for pelvic organ prolapse. ACOG applauded the FDA efforts to 'protect women's health and educate providers' regarding the safety and effectiveness of this procedure and encouraged their Fellows to be prepared for questions from their patients.

I also appreciate their efforts and public announcement and certainly agree with the concerns; back in 2007 when I attended an ACOG meeting lecture on the topic many of the physicians had experienced problems with their patients' surgical devices -- more seemingly than had reported the problem. Many questions that women have are addressed in the chapter on pelvic problems in my latest book, Hormones and Your Health (click for details) which I hope will inform women and their physicians about the options they have to make the best personal choice."

Declining Pelvic Muscle Tone:
Pelvic Prolapse and Urinary Incontinence

Excerpts from Chapter 6;

What You Should Know about Surgical Devices and Therapies

FDA approval doesn’t mean risk free. The FDA does not generally require that clinical trials be conducted before surgical devices for incontinence, such as the implantable meshes and vaginal tapes, are marketed. The complex “Premarket Approval Application” of devices, once it is completed with studies and approved, does assure the public that the devices are safe and effective if used the intended way. Most legally marketed devices, however, bypass this rigorous screening. “The Premarket Notification 510(k)” is a shortcut: a submission process to the FDA that demonstrates that a new device is “substantially equivalent” to a legally marketed device. If the new medical device is so approved, it may be legally marketed and distributed in the United States.

Unfortunately, this shortcut exposes consumers to certain risks. For example, hernia-repair surgeons have made great strides through innovations in the type and the design of mesh products, which were inserted during surgery to hold tissue in place. This led to government approval for these mesh products for hernia repairs.565

The mesh products were then approved as devices for vaginal slings using the 510(k) shortcut. According to experts,87, 562 this usage, and its FDA approval, was a mistake. Unlike the sterile field of hernia repair surgery, vaginal surgeries are not sterile. Instead, they involve a clean but not sterile region that potentially introduces bacterial infection where the sling is placed.

In 1996, the ProteGen sling, made from mesh used in cardiac surgery, received FDA approval through a 510(k) Premarket Notification. Other slings, including the TVT, rapidly followed.

Long-term safety studies are not required.
Although manufacturers are not required to demonstrate long-term safety before bringing these devices to market, the FDA does have a Web site where people can report adverse reactions. Called MAUDE (Manufacturers and Users Device Experience: www.fda.gov/cdrc/maude/html), it is voluntary for physicians but required for manufacturers, and it’s not being used as it was intended.

In 1995, there were 9,000 new devices and then in 2000 13,000 devices introduced in the marketplace, and these outpaced the FDA’s ability to inspect them (3,602 inspections were performed in 1995 and 1,841 in 2000). This is very dangerous for the woman who is considering surgery using a new device. One such UI device yielded a 30 percent erosion rate in that sling after five months.568 The erosion of inserted material causes major health problems as the tape breaks apart, embeds into human vaginal tissue, and produces scars, internal bleeding, pain, and infections.

You can’t assume that the lack of reported adverse effects means there aren’t any. Even if you do a background check on the technique or the device you’re considering for UI, you may not run across any adverse effects. Don’t assume this means that the device or the technique has a high rate of success. Dr. Peggy Norton, a gynecological surgeon whose main practice involves surgical repair of these mesh erosions, published shocking conclusions about problems with these tapes. She presented a lecture to about 150 doctors at a recent continuing medical education seminar held at the annual clinical meeting of ACOG (American College of Obstetrics and Gynecology). –87, 562 She described her personal three-hour ordeal to remove one set of eroded tapes and said that many women have come to her with such problems. She related how these distressed women had been stonewalled by the original surgeon, who falsely claimed that each was the only patient in whom this unfortunate circumstance had occurred.Dr. Norton knew that these were lies because she was treating multiple patients with the same problems from the same set of surgeons.

As perhaps the only biologist in her audience, I was amazed to see the show of hands from surgeons who said yes, they too had experienced adverse reactions in their patients’ mesh erosion repairs, requiring additional surgery after other surgeons had inserted these tapes. I counted about 50 of the 120 attendees who raised hands; only 1 surgeon raised a hand to the second question, acknowledging that he had also reported it to MAUDE.

Dr. Norton explained that filing the report is tedious, time-consuming, and not obligatory for surgeons. Doctors can tell the manufacturer’s sales representatives, who should report them on MAUDE, but Dr. Norton found that they don’t “get around to reporting” what is conveyed to them. She likened this to asking the fox to protect the hens in the henhouse.

It is a dangerous world for consumers who seek pelvic surgery. Case reports of problems (bladder erosions, dyspareunia, dysuria, bacterial infection) with the tape procedures have also recently been published.15, 589, 626, 757– Unfortunately, unlike the MAUDE Internet site, these are even more difficult for the consumer to find.

***

(More about prolapse from chapter) With age, inactivity, and sometimes disease, muscles throughout your body may become flabby, weak, and unable to support your body structures. The muscles of your pelvic floor are no exception. Pelvic muscle weakness can result in incontinence (an inability to control your bladder or bowels) and/or prolapse (the dropping of the uterus, the bladder, and/or the rectum within the vagina or past the vaginal opening). Vaginal vault prolapse is the descent of the top of the vagina, which typically occurs after a woman has had a hysterectomy.156 Prolapse may be caused by inadequate muscle tone. This usually results from childbirth, but there may be other causes.

Pelvic organ prolapse generates between 200,000 and 300,000 inpatient surgical procedures annually in the United States.106, 165, 566

...If you’re assessed with one stage, though, it may not get worse. According to Dr. Anne Weber, prolapse is dynamic, rather than progressive. In fact, it often regresses.823 In other words, you can have the condition one year and not the next.92 Obesity is one of the few modifiable risk factors that have been identified as a cause. As usual, it helps to watch your weight.

Prolapse: Fairly Common, but Not Deadly

No populationwide data have been gathered in the United States, but investigators estimate that 30 to 93 percent of mobile women will experience prolapse.566

Examinations of 270 Iowa participants in the Women’s Health Initiative Study revealed that 65.2 percent were at least at stage II or beyond and 25.6 percent had the leading edge of internal structures protruding outside the vagina. The investigators concluded that pelvic organ prolapse is common and some degree of prolapse is normal, especially in women in their mid 60s.566 Neither hormone therapy, the number of pregnancies, nor vaginal delivery were associated with the occurrence of prolapse. But for women who did have prolapse, those with more than two vaginally delivered babies were more likely to experience further descent over time.92 Those most at risk were in poor health status overall.652

What is the Cause of Prolapse?

... The majority of women who undergo pelvic floor reconstructive surgeries have previously had hysterectomies in each of the studies that list prior surgeries.709 Possibly, surgical removal of the uterus further weakens the supporting structures that are needed to hold the pelvic anatomy in place.
Do you need to do anything about prolapse? It really depends on you. Although some authors state that women with prolapse suffer from chronic pelvic pain and pressure, urinary and fecal incontinence, sexual dysfunction and social isolation,526 other experts assert that pelvic pain is not associated with prolapse and, frequently, prolapse is not a problem that requires surgery.823 A stage IV prolapse with internal structures protruding outside the body will obviously be a problem, as well as a medical emergency if the woman is unable to urinate. Fortunately, this is relatively rare,823 occurring in less than 7 percent of women.652 Moreover, the actions you take with stage II or III prolapse may prevent the further descent of the prolapse.

There is no inevitability that the problem will worsen, and prolapse does not demand treatment (or surgery) unless you are currently suffering.

Nonsurgical Approaches

Kegels
For women suffering from significant effects of prolapse, pelvic floor rehabilitation through Kegel exercises—pelvic floor muscle training—may be helpful.823 (It certainly can’t hurt!) The American Physical Therapy Association (www.apta.org) can help you locate local practitioners.

Exercise Modifications
Apparently, no studies have addressed the questions I asked my mentor, Dr. Garcia, more than thirty years ago. I wondered whether aging bodies could safely endure jumping-type sports. If ligaments were losing their elasticity, was it sensible to play tennis or volleyball or run? Wouldn’t low-impact fitness regimens such as swimming, dancing, walking, and weight lifting better serve the woman? Dr. Garcia agreed that the idea was rational. I feel that women can use their own wisdom to guide their choices.

A Support Device
A pessary is a plastic device, such as a ring, placed in the upper vagina to keep the uterus in position when ligaments are too weak to support it. According to Dr. Anne Weber, if a pessary is properly fitted and placed, a woman should be unaware of it and unrestricted in her activity. Pessaries can be removed, cleaned, and reinserted as needed. Vaginal ulceration and irritation can result when routine hygiene is ignored. A properly fitted pessary can help a woman delay or avoid surgery.

Hormones
Vaginal estrogens are often prescribed, because they are beneficial in restoring atrophic tissue and reducing the likelihood of ulceration, especially in conjunction with pessaries.

Surgical Repair
Take your time when making a decision about surgery. Unfortunately, the surgery itself can predispose women to future prolapse, painful intercourse, incontinence,709, 823 and adhesions.

Do the surgeries that are available actually work? According to 80 published studies, the recurrence rates of prolapse ranged from 9 percent (a good result) to 55 percent, with more recurrence likely as longer amounts of time have elapsed since the surgery.824

 

Hormones and Your Health