- Florida Today

08/09/2011 - As the U.S. Food and Drug Administration considers stricter regulations for approving medical devices, whatever the federal agency decides comes too late for several local women.

Damaged, they say, by mesh devices implanted to treat a common pelvic floor disorder, all of them tell similar stories about doctors' assurances the devices might help.

"For six weeks, I was walking around with the equivalent of barbed wire inside me," said Lisa Smith, describing her pain, which never has fully subsided, despite additional surgeries.

At 46, she's the youngest of four women, all from the Melbourne area, who are part of one of dozens of lawsuits against mesh manufacturers, this one involving about 300 women in 34 states.

The women are seeking unspecified damages for injuries received as a result of having these products placed inside them to keep their pelvic organs in place.

The manufacturers maintain surgical mesh products are an important treatment option for patients with pelvic organ prolapse. And although the Food and Drug Administration issued an updated safety communication to patients and providers in early July, the agency agrees, at least for now.

In pelvic organ prolapse, pelvic muscles and tissues, weakened by age, childbirth or obesity, can drop. Sometimes, it's the bladder or the uterus that slips out, other times the top of the vagina loses support and drops through the vaginal opening. The rectum or the small bowel can be compromised as well.

An estimated 30 percent to 50 percent of women older than 50 experience some type of organ slippage, according to federal data. And about 10 percent of them develop severely uncomfortable or embarrassing symptoms, which can destroy their quality of life.

"I always brought an extra set of clothes to work, but it became too much," said Smith, who suffered from incontinence for months before deciding to have a specialist implant a mesh device inside her vagina last year. Instead of relief, she said, the mesh eroded tissue and protruded from her body, the incontinence worsened and she lost her job and her health insurance.

"It's the gift that keeps on giving," said Henry Garrard, the women's attorney, based in Athens, Ga., and the lead attorney for his firm's cases. A federal judge in West Virginia, overseeing the discovery process, can either settle the lawsuits, he said, or send each case back to its original jurisdiction for a jury trial.

On July 13, the FDA issued its updated safety communication about the mesh products' use for pelvic organ prolapse. Four companies are the main manufacturers of these devices: Ethicon, a division of Johnson & Johnson; C.R. Bard; Boston Scientific; and American Medical Systems. The first FDA safety communication was issued in 2008.

Since that time, the agency said, these products have been of "continuing serious concern," and health care providers should recognize that, in most cases of pelvic organ prolapse, the condition can be treated successfully without mesh.

While the FDA plans to convene a panel of experts in September to further discuss the safety and effectiveness of surgical mesh for this condition, however, the products for this use still remain on the market.

"Here's the thing. Some in the clinical community still believe this is the best option for select patients," or those with extreme organ prolapse, said Karen Riley, an FDA spokeswoman. That's one of the reasons the agency has not pulled the mesh devices off the market, she said.

At the September meeting, Riley said, the expert panel will re-evaluate and make recommendations to the agency as to the risks and benefits of surgical mesh in treating this condition through the vagina rather than through the abdomen, which has been done since the 1980s. The experts also will look at the use of surgical mesh in the treatment of stress urinary incontinence, which was not addressed in the agency's safety communication.

Denise Kaigler, Boston Scientific's senior vice president for corporate communication, said the company believes transvaginal placement of mesh to treat pelvic organ prolapse and incontinence "remains an important treatment option for patients."

In an email, she said the company intends to continue working with the federal government to ensure patients and doctors get appropriate information, so "they can make fully informed decisions" about treatment.

Mesh's serious complications
In its updated communication, the FDA described serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse as "not rare." Such wording is highly unusual, according to Garrard, who calls these devices a mechanical mismatch with the body.

Although the mesh products are not identical, he said, they all are made of polypropylene, a type of plastic that is "not inert, as the manufacturers' claim, but sets off an inflammatory process."

And once implanted, they are permanent fixtures.

"Mesh is like a screen door, so cells do grow in and out of the opening," said Dr. Tomas Griebling, vice chairman of the department of urology at the University of Kansas. Because of this, "it's not possible to get the mesh entirely out."

Griebling, a practicing urologist, said there's debate over the best care for pelvic organ prolapse, with treatment often tailored to each person.

"A lot of surgeons use mesh; a lot don't," he said.

He prefers to use natural materials. But mesh may have a place in treating some women with prolapse, he said, indicating he would not comment further because of the litigation.

Discomfort increases
In Dorothy Vogt's case, problems in her pelvic region began shortly after her husband died in 2006, probably as a result of trying to lift him during his battle with Alzheimer's disease, she said. The gynecologist told her about the mesh option. "She said it would be wonderful, and I'd feel like a new person."

Instead, shortly after the procedure in October 2009, the pain got worse, Vogt, 74, said. When she sought relief, a second doctor "cut away some of the mesh on an outpatient basis," which didn't help.

Today, she's no longer able to exercise and suffers with constant bladder infections. But what bothers her most, she said, is she no longer can pick up her grandchildren.

"I always took care of myself my whole life," she said. " I thought this would be a breeze."

Similarly, Charlene Reinhardt of Melbourne Beach and Patti Stalnaker of West Melbourne looked to the mesh device to bring normalcy back to their lives.

Reinhardt said she had a prolapsed bladder, which caused discomfort, "but not a lot of pain." Still, "I thought to myself, 'It's time to get it fixed,' " she said, taking a six-week medical leave from her job to do so.

The further out from the initial surgery she got, she said, the worse it got. The mesh eroded not only her rectum, but also her lower abdomen. Like the other women, doctors snipped out some of the mesh in a repeat surgery, but the pain stayed.

"Some days are worse than others," the 69-year-old said.

Stalnaker, for her part, described her prolapse as puzzling at first, as her bladder began slipping out. But, in retrospect, she said, her life pre-mesh was better than it is now.

"If I laughed very hard or did a jumping jack, I would be incontinent, but otherwise, I was OK," she said. "I never was truly incontinent, although I was on my way."

For months after her 2008 surgery, however, Stalnaker developed numerous infections under the mesh and "then I knew something was not right." With that realization, she said, she switched doctors and had another outpatient surgery to "clean the mesh out."

It didn't work. "I get sharp, shooting pains every day," Stalnaker said.

'Question the mesh'
None of the women asked or received a second opinion before getting their mesh devices.

And none was suitable for a pessary, they said, a plastic or rubber device that can be a nonsurgical option for keeping pelvic organs in place.

Asked what they might do differently today, Reinhardt said, "I would definitely question the mesh, get a second opinion and Google it to find out more," she said. "An expert specialist is supposed to take care of this problem, but in our case, that didn't happen."

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 or fill out the free case evaluation form on this page.

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::