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The Trouble With Transvaginal Mesh
Why did the FDA ever approve a product that has injured thousands of women? There's plenty of blame to go around.
Jim Burger
Publish Date: August 3, 2016   |  Tags:   OB-GYN
transvaginal mesh

The controversy surrounding vaginal mesh is a tale of greed and incompetence. That's something people seem to agree on. The question of whose greed and whose incompetence is where they begin to vehemently disagree.

The truth may be somewhat elusive, obscured by accusations flying back and forth among plaintiffs' attorneys, medical device manufacturers, the federal government, physicians and patients. Caught in the crossfire are the women who've become collateral damage — those who had pelvic meshes and slings implanted to treat either stress urinary incontinence or pelvic organ prolapse (POP) and who suffered dire, sometimes irreversible, complications as a result, including urinary dysfunction, loss of sexual function, constipation and severe pain.

The saga, which began in the 1990s, continues in 2016, playing out in boardrooms and courtrooms across the country. Tens of thousands of product liability lawsuits against mesh manufacturers like Johnson & Johnson subsidiary Ethicon, Boston Scientific and Endo International are pushing forward and hundreds of millions, if not billions, of dollars have already changed hands as a result. In 2014, Endo said it would pay about $830 million to settle more than 20,000 personal injury lawsuits that alleged its vaginal mesh implants eroded in some women and left them incontinent and in pain.

What remains to be seen is whether surgeons will continue to implant vaginal mesh.

"What I'm afraid is going to happen is that 5 years from now we won't have any of these (mesh) products around," says urologist Brian A. Feagins, MD, medical director of the Texas Health Women's Specialty Surgery Center in Dallas.

That would be fine with L. Lewis Wall, MD, a professor of obstetrics and gynecology at Washington University School of Medicine in St. Louis, who has petitioned the U.S. Food and Drug Administration to recall all vaginal mesh products and ban further commercial sales. The wide disparity in the 2 physicians' attitudes reflects the different perceptions about what led to this epic problem, and about who's to blame for the mesh mess.

Brian A. Feagins, MD PRODUCT PLACEMENT Urologist Brian A. Feagins, MD, (right) says vaginal mesh isn't to blame — it's doctors who mistakenly place it. "Mesh doesn't erode into the bladder, it doesn't erode into the urethra. It was placed there in the first place and the doctor just didn't know it," he says.

Blame the FDA?
Some see the FDA as culpable, since it let vaginal mesh be brought to market without clinical trials. Its 510(k) process is a pathway for approval based on "predicate" devices — approved products that are deemed to be essentially similar in form and function to new products. The predicate product in this case? The mesh used to repair hernias.

Dr. Wall, who calls the FDA approval process "terribly flawed," says the fact that hernia mesh was viewed as a legitimate predicate is absurd. "They took material used in vascular grafting and said it's already been used in the body, therefore we can use it in the vagina," he says. "As if a vascular graft and a vaginal graft were the same thing, or as if the interior abdomen wall is the same as the vagina. You don't need to be a rocket scientist to appreciate that they're different structures with different functions."

Vaginal mesh is now facing increased federal scrutiny. The FDA has relabeled it from a moderate device to a class III high-risk device. This past January, the FDA took the unusual step of giving manufacturers 30 months to submit documentation "to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP." Are these measures too little, too late?

"FDA-bashing is a fun pastime for a lot of people," says Steve Xu, MD, co-author of a recent study on the FDA's regulation of women's health devices (osmag.net/uhc6tv). "But it's important to remember that it has immense responsibility and limited resources."

Dr. Xu and co-author Jessica Walter, MD, both residents at the Northwestern University Feinberg School of Medicine in Chicago, found "significant weaknesses in pre-approval and post-approval regulation" when they examined the approval process for 18 high-risk obstetrics and gynecology devices approved between 2000 and 2015. While high-risk implant devices require the most scrutiny, the researchers note that the FDA is mandated to take the least burdensome approach.

"When you have a device that's placed permanently in the body, there needs to be assurance that you have sufficient data collected over a reasonable period of time, sufficient post-marketing follow-up and a better, more robust population-tracking system," says Dr. Walter.

Additionally, clinical trials are both extremely expensive and much more challenging for implantable devices than they are for drugs, since, among other things, no placebos are available. The problems, says Dr. Wall, are institutional.

"Corporations didn't want to invest the time and effort into doing clinical trials that would show the mesh implants were safe and effective procedures," he says. "A lot of these medical devices don't have physicians driving the process. They're engineers and marketers, and once the products were developed, it was the marketing arms that ran with them to maximize sales. The calculation at the end of the day is that they'll have more profit than liability and they'll end up ahead of the game."

Thomas L. Lyons, MD, MS, FACOG FOREIGN RELATIONS "Any time you place a foreign material in the body, there could be consequences," says obstetrician-gynecologist Thomas L. Lyons, MD, MS, FACOG, (right).

Poor product or poor placement?
Dr. Feagins thinks poor surgical technique is more to blame than a faulty product. He estimates he's implanted about 5,000 mesh slings to treat incontinence and performed about 550 mesh prolapse repairs. "Overall, these patients do very, very well," he says. But, he acknowledges, other physicians have not been as successful.

"Admittedly, some patients have had big problems, and — full disclosure — I've been involved as an expert for the defense in many of these cases," he says. "But in almost every case I've looked at, it's not a problem with the product. It's a problem with how the product was used. Most cases involved someone not very experienced placing these products, and doing it incorrectly. Mesh doesn't erode into the bladder, it doesn't erode into the urethra. It was placed there in the first place and the doctor just didn't know it."

It comes down to which physicians should be doing these cases, and which shouldn't, says Dr. Feagins, even suggesting that surgical facilities closely regulate who can implant vaginal mesh. "Maybe you should have to demonstrate that you've been proctored for a certain number of cases," he says.

"It looks easy and it is easy to me," he adds. "But to somebody who's not doing the procedure a lot, that may be a recipe for disaster."

Should physicians have been more wary of vaginal mesh at the outset?

"I don't think anybody foresaw what was going to transpire," says Thomas L. Lyons, MD, MS, FACOG, of Advanced Gynecology Associates in Conyers, Ga. "But any time you place a foreign material in the body, there could be consequences." He also notes that clinical data support the use of mesh in suburethral slings. "It is the gold standard," he says. "It delivers as good a result as you're going to get for urinary stress incontinence."

Dr. Feagins agrees. "There's zero question that mesh-based slings are the gold standard for treatment of stress incontinence in 2016 and have been for the last 10 years," he says. "People have short memories about what we did in the past and what kinds of problems there were. They're quick to scold us for using mesh, but in my hands, these products have done very well. Yes, we have complications, but there's not an incontinence operation that's ever been done that doesn't have (the potential for) complications."

There's less confidence overall about the efficacy of treating prolapse with mesh, however. "I have definitely reduced my use of mesh for those purposes," says Dr. Lyons.

"We shouldn't be using mesh for every single patient who has prolapse," says Dr. Feagins. "But when it's used correctly, and appropriate tissue planes are found, and the product is placed where it's supposed to be placed, it's basically a great product, and it helps people who have very, very bad prolapse situations."

A lawyer's delight
Many women have been helped, but many have been hurt, too. And attorneys have picked up the scent of deep-pocketed device manufacturers. (We contacted several mesh manufacturers for this story, but none responded.) From TV ads to cold-calling certain demographics, such as "all the phone numbers in Dallas, Texas, of women over the age of 45," there's now an all-out effort to recruit patients for class-action lawsuits, says Dr. Feagins.

"They're trying to make as much off this as they can," he says, "but I'd argue that the vast majority of patients don't have a problem with the mesh. And no mesh has been recalled by the FDA. Not one piece. Nobody has ever shown that the product is the problem."

The ultimate fallout, Dr. Feagins fears, is that mesh manufacturers will throw in the towel. "The industry will say, forget it, I'm not going to hang my butt out here anymore, because it's just too costly for us. And we'll go back to what we did 20 years ago, and people aren't going to be happy with that either. It kills me to know that I'm not going to have these products because of all this litigation. That's the piece of this that people aren't thinking about."

On this point, too, there's ample disagreement.

"For many conditions, the traditional techniques that were bad-mouthed and trashed by commercial interests for a decade actually stand up a whole lot better, particularly when you remove all the side effects that you avoid by using them," says Dr. Wall. "Some of the re-analysis and clinical data show that. Careful surgical techniques with new suture technologies — there's no substitute for old-world craftsmanship." OSM