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.
Pamela Danek, a 52-year-old teacher from Vestal, N.Y., had surgery in July 2007 to repair a prolapsed uterus and cervix. The doctor didn’t use mesh, and within three weeks the problem returned, she said. After a second surgery to remove her cervix, she was in a lot of pain. She went to Lucente in August 2008 and he implanted the mesh. After that surgery, she was able to exercise again and her life returned to normal, she said.
“I do understand that there are people who have suffered from the mesh, but in my case it’s been very positive and life-changing,” she said. “I’d hate to see the whole product go away. … It’s amazing when it’s done correctly what a positive impact it can have on a woman’s life.”
One of the lead attorneys representing women suing the mesh manufacturers, Athens, Ga.-based lawyer Henry Garrard, said problems may arise because some surgeons don’t know much about mesh, but he said it’s the manufacturers’ responsibility to educate doctors about their products. For the most part, his clients have not sued individual doctors, he said, because he claims the problems are caused by the mesh products themselves.
The cases have been consolidated in West Virginia because that’s where a lot of them were initially filed, Garrard said. Several thousand other lawsuits have been filed in state courts, he said. In what is believed to be the first lawsuit of this type to go to trial, a California jury in July awarded a California woman $5.5 million in her case against C.R. Bard.
A trial for five bellwether federal cases against Bard is set for June and trials for American Medical Systems, Boston Scientific and Johnson & Johnson subsidiary Ethicon are staggered over the next year.