- Post-Gazzette

07/26/2011 - The FDA earlier this month renewed safety warnings on the use of mesh through the vagina to repair pelvic organ prolapse, saying the procedure could pose greater risks than other remedies for the condition that strikes thousands of older women every year.

While two local surgeons said the FDA update provided good advice for patients to seek information on all treatments and to be vigilant on addressing complications, they feared the warning could cause unnecessary anxiety among patients and prompt some surgeons to stop doing the procedure.

Halina Zyczynski, director of the Division of Urogynecology and Pelvic Reconstructive Surgery at Magee-Womens Hospital of UPMC, said the "vast majority" of women do not experience complications.

"The estimate is about 10 percent, and of those 10 percent, although some have very debilitating complications, most do not," she said.

That was one of the reasons she has concerns that the warning will create "a very high level of anxiety for women."

"But I believe the anxiety can be addressed in a thoughtful informed consent process," she added, "so overall I really do applaud the FDA for giving this area higher consideration."

As women age, many experience a weakening of the pelvic muscles and ligaments that support organs like the bladder and uterus, causing them to slip out of place, or prolapse. Childbirth, menopause, hysterectomy and other issues can lead to this condition.

Surgery to repair the condition can be performed through the abdomen or through the vagina, using stitches or with a surgical mesh to reinforce the repair and correct the anatomy.

In 2010, there were at least 100,000 pelvic organ repairs made using mesh, of which 75,000 involved placing mesh through the vagina, or transvaginally, according to the FDA.

Michael Pelekanos, vice chairman of Obstetrics and Gynecology at the Western Pennsylvania Hospital Forbes Regional Campus, said the transvaginal approach is less invasive. The mesh he employs allows the use of the patient's tissue to reinforce the repair.

The FDA first issued a safety notice over the procedure in 2008 due to increasing problems, and complications have continued to climb. It received more than 1,500 reports of mesh-related complications between Jan. 1, 2008, and Dec. 31, 2010 -- five times as many as the agency received from 2005-07 -- and said there appeared to be lower rates of complications for mesh placed through the abdomen, rather than through the vagina.

The caution that serious complications "are not rare" provides good advice on questions patients should ask their surgeons, including experience level, Dr. Pelekanos said.

Also good is a recommendation that post-surgical patients continue to have screenings for potential complications, Dr. Zyczynski said.

At Magee's Women's Center for Bladder and Pelvic Health, an estimated 25 percent to 30 percent of those who seek treatment will have mesh-augmented prolapse repair, she said. She personally has done more than 2,000 prolapse procedures with mesh, of which 300 were done transvaginally.

Dr. Pelekanos has done more than 150 mesh-augmented repairs but also does the repair without mesh if there is appropriate tissue support.

He said he believes the problems that led to the FDA advisory were prompted by gynecologists doing the repairs without the proper training or the right technique.

He believes the surgeons should be proctored for at least 10 cases before doing the procedure. "It's unfortunate the pharmaceutical manufacturers believe a surgeon can observe one or two cases and do one on their own," he said.

"The pharmaceutical companies should foot the bill for proctoring 10 cases and if they did that I strongly believe the complication rates would mimic other procedures."

Dr. Pelekanos said that the FDA advisory and a statement from the American College of Obstetricians and Gynecologists applauding the agency's concerns about mesh placement for prolapse could affect its availability.

"With this kind of thing, doctors are going to stop doing them. It's a shame because it offers benefits to patients troubled by this. ... Standard repairs just don't work," he said.

"I truly believe having done [the repair both ways], mesh offers the superior result."

If you or a loved one have suffered or been injured from a defective transvaginal mesh sling you may be entitled to compensation. Contact the vaginal mesh sling attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding your transvaginal mesh sling injury a possible class action lawsuit, or any other type of vaginal mesh litigation. Call us toll-free at: 1.800.856.6405.

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