For too many women, an unending and painful tangle with surgical mesh

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Tens of thousands of women complain that a surgery to implant mesh to bolster weak abdominal tissue, instead has inflicted on them incontinence, chronic pelvic pain as well as pains in the groin, hip, and leg, and with intercourse. Others say they suffer complications as if they had the immune system attacking disease lupus, leaving them with persistent runny noses, muscle pain, fogginess, and lethargy.

The federal Food and Drug Administration in mid-February will convene its expert panel on women’s reproductive surgeries to see advice on next steps in what has become a legal and medical morass over transvaginal mesh operations.

As many as 4 million women globally have undergone mesh surgeries to treat urinary incontinence and weakening of walls in the abdominal area that causes prolapses, the Washington Post reported, quoting a UCLA reconstructive expert as estimating that 5 percent — or 150,000 to 200,000 — of those patients have experienced complications.

Experts told the newspaper that many procedures go fine. Women can be pleased that, after problems related to childbirth, pregnancy, and stresses and strains, they can be active again, including with vigorous exercise, without worry about embarrassments like urine leaks and the need to wear adult diapers. Specialists say the mesh has provided a better way to support and contain organs that might otherwise move or bulge in women’s bodies.

But patients react differently, depending on the mesh material and the surgery, the Washington Post reported. More than 100,000 lawsuits have been filed, asserting that the mesh degrades and can join or almost melt into women’s internal tissues, causing infections, pain, and other major complications. The newspaper quoted experts who said that procedures’ damages can be irreparable, due not only to scarring and destroyed tissue but also because getting out the mesh can be far messier — and a lot more consequential — than removing a wad of chewing gum from the hair. The mesh also can move and become brittle, with patients experiencing painful sex and partners finding the material no longer in or near a wall but “eroding” in and out of the vagina.

Experts say that patients seem to fare better with mesh made up of organic material, including patients’ own tissues, rather than polypropylene. Some specialists argue the mesh works better for incontinence and that issues arise more when it is used in a sling for POP — pelvic organ prolapse.

Multiple makers have put out mesh products. Some already have settled thousands of lawsuits for hundreds of millions of dollars, while the Washington Post reported that others are standing by their items and stockpiling billions of dollars to prepare for possible losses in individual and class-action suits.

The legal cases pit specialists against each other, with the newspaper noting that surgeons and their organizations have ended up on opposing sides, pointing fingers at colleagues and onetime proteges and asserting bad practices and conflicts of interest when experts have taken device-maker money for endorsing, promoting, or using companies’ product.

Separately, the New York Times has detailed how some lawyers have created controversies by funding potential lawsuit clients’ mesh removals. Judges and juries may be more sympathetic and inclined to decide cases in favor and award damages to women whose cases seem more severe, enough so that mesh extraction is required, the paper says. The procedures can be so difficult, invasive, and painful for patients, they may be better off if they forego the follow-up mesh-removal surgery. Lawyers pay for the work and say they do so only if it benefits the health of their clients. They emphasized that they do not get repaid for the surgeries unless they also win their clients’ cases.

As for the FDA, it, too, is taking fire for dawdling in what has become yet another situation in which sizable numbers of women have claimed injury before the agency moved. Regulators received thousands of complaints before they shoved mesh products into an agency classification that will mean any new such items will undergo rigorous scrutiny before it can get on the market.

That, effectively, is closing the proverbial barn door after …. the mesh had won clearance from the FDA under its so-called 510(k) process. The agency has promoted planned changes in this path, in which companies can point to an old and existing product, assert theirs is similar, and get waved ahead to sell the new medical devices. Since the 1970s, when lawmakers gave FDA sway over such devices, the agency has not only grandfathered most products. It also has allowed makers, even now, to cite precedents going back decades to avoid tough oversight, including clinical trials with humans, that prescription drugs must undergo.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damages that can be inflicted on them by defective and dangerous products, notably medical devices. FDA Commissioner Scott Gottlieb has sought unsuccessfully to sell a “transformational” change in the way medical devices get cleared, chiefly by shortening the past which makers can cite as precedents for products to get pushed on to the market. Pro-industry lawmakers and Gottlieb say regulators shouldn’t stand in the way of products that can benefit and even save lives. But journalists and safety advocates have shoved back hard against his claims, showing how the agency seems to be a far stronger advocate for device makers than for patients.

Without leaping ahead of the wisdom of courts across the country, the volume and extent of complaints about mesh and its use in women should be cause not for stalling but action and alarm. FDA regulators can’t nod their heads, maybe roll their eyes, and ignore outcries about injuries caused by products and procedures affecting women’s reproductive health. Did the agency, doctors, and hospitals not shame themselves enough with their slow response to concerns in other situations, including the cancer-spreading morcellator (tissue grinding device) and minimally invasive surgeries for early-stage cervical cancer.

The new Congress, to voters’ credit, has more women than ever in its ranks. Let’s see how Gottlieb and surgeons and hospital administrations respond to a grilling in oversight hearings with excellent, able female lawmakers about what caregivers are up to with and for tens of millions of women.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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