For some women a pelvic transvaginal mesh product has been a god sent. To be able to resume a full active life, without the worry of a leaky bladder, is a true miracle for some women. And, this only became possible with the help of pelvic mesh.
The mesh is most commonly used after pelvic organ prolapse, or when muscles in the area weaken, causing organs to bulge or slip down into the vagina. It can happen because of age, childbirth or other reasons and can cause pain and bladder leakage. It is also used to treat stress urinary incontinence.
But, for others the mesh itself has caused more pain and trouble than the pelvic organ prolapse that they started with. Many women allege they sustained serious, painful and life-changing injuries following implantation of the vaginal mesh.
With pelvic mesh lawsuits on the rise, who is truly at fault- the product, manufacturer, or surgeon implanting device?
When pelvic mesh products were introduced, they were seen as a high-tech improvement over traditional surgery using stitches and a woman’s own body tissue, which also can have complications. Since similar mesh was already used in other types of surgery, including for repairing hernias as far back as the 1950s, the products received fast-track approval from the FDA without the tests that the agency requires for first-of-a-kind devices.
The FDA cleared the mesh — often a soft, lightweight porous plastic — for pelvic organ prolapse in 2002, and the agency said in a 2008 public notice that problems were “rare.” In July 2011, however, the agency said it erred in its initial assessment and estimated the most common problems occur in 10 percent of women within a year of surgery.
The mesh can be inserted through the vagina or through an incision in the abdomen, though the latter is less common and has significantly fewer complications, the FDA said. The problems involve shifting and erosion of the mesh, as well as infections.
A year ago, the FDA ordered several dozen manufacturers to conduct rigorous studies to track the complication rates with their surgical mesh products over time. Some companies have undertaken those studies, while others chose to stop producing certain products.
Dr. Cheryl Iglesia, a surgeon in Washington who was on the FDA panel, said things have come a long way over the last year. A national registry to track pelvic prolapse surgeries should help identify problems more quickly — whether they’re caused by patient complications, surgeons with inadequate experience or the mesh itself, she said.
Some doctors have also been reconsidering when to use the implantation, and the mesh products have become smaller and lighter, she said. She uses the newer, smaller mesh products on some of her patients.
“To some degree, the marketing of the mesh may have been ahead of the science,” she said.
Dr. Vincent Lucente, a Pennsylvania doctor who specializes in female reconstructive pelvic surgery, is among a group of doctors who have spoken out against the FDA’s warnings. The main problems with the mesh products are caused by surgeons who don’t have enough training, he said. Publicity from the lawsuits scares women into refusing treatment with the mesh even though they could benefit from it, he said.
“It is a tragic moment in our field where there’s public sentiment and perception being developed by lawyers and not by physicians,” he said. “The innovation — and the skill sets to use the innovation — is outpacing the skill sets that the surgeons have, and no one is trying to close that gap.”
Lucente believes there should be a credentialing process to ensure expertise, as there is for other surgical procedures.