Years of activism have made women’s health a top­ic of every­day con­ver­sa­tion. The mechan­ics of mam­mo­grams and the pros and cons of cer­vi­cal can­cer vac­cines are famil­iar, but one com­mon health prob­lem that affects mil­lions of women remains vir­tu­al­ly unknown.

When mesh works its way out through the vaginal wall and extrudes into the vagina, the woman experiences excruciating pain. During intercourse, mesh can lacerate her partner's penis.

Time, grav­i­ty and child­birth can weak­en a woman’s pelvic floor mus­cles and stretch out the lig­a­ments that hold up her uterus, blad­der and/​or bow­el, caus­ing the organs to sag and bulge into the vagi­na — or even pro­trude from it — a dis­or­der known as pelvic organ pro­lapse (POP). Up to half of all women will devel­op some degree of pro­lapse, and the diag­no­sis will become more com­mon as the Baby Boomers age. One in 10 women suf­fer­ing from pro­lapse will even­tu­al­ly need surgery to cor­rect it, and every year about 300,000 women under­go pro­lapse surgery.

The symp­toms depend on which organs are bulging and how much. A blad­der bulging through the front wall of the vagi­na can cause incon­ti­nence, or dif­fi­cul­ty void­ing. A pro­lapsed rec­tum or small intes­tine can inter­fere with defe­ca­tion. Women with pro­lapse may report pain dur­ing sex, a vis­i­ble bulge, or a feel­ing like some­thing is about to fall out of the vagina.

The con­di­tion can be debil­i­tat­ing and demor­al­iz­ing — though rarely life-threat­en­ing. But for some patients, the cure can be worse than the disease.

Pro­lapse repair kits

In med­ical and reg­u­la­to­ry cir­cles a con­tro­ver­sy is rag­ing over the use of non-absorbable mesh for the trans­vagi­nal repair of pelvic organ pro­lapse. Use of the mesh has been linked to per­ma­nent and dis­abling com­pli­ca­tions, includ­ing chron­ic pain, nerve dam­age and infec­tion. To many health activists, syn­thet­ic trans­vagi­nal mesh is a poster child for the flaws of our med­ical device reg­u­la­tion system.

One com­mon way to repair pelvic organ pro­lapse is to shore up the sag­ging tis­sue through an inci­sion in the vagi­nal wall, a kind of surgery that has long been the pre­serve of high­ly trained pelvic recon­struc­tive sur­geons. But since the ear­ly aughts, mesh for trans­vagi­nal pro­lapse repair has been increas­ing­ly sold in kits, which typ­i­cal­ly con­tain pre-cut pieces of mesh and long nee­dles to push the mesh deep into the pelvis and anchor it to the pelvic floor. These kits have opened up POP surgery to much less expe­ri­enced surgeons.

Kits are also prof­itable for device man­u­fac­tur­ers. In 2010, 79,500 mesh kits were sold in the Unit­ed States. A sin­gle kit of ster­ile mesh and dis­pos­able instru­ments — cheap raw mate­ri­als — yields a healthy prof­it mar­gin when sold for $2,000 apiece. About 20 POP mesh prod­ucts are cleared for sale and active­ly mar­ket­ed in the Unit­ed States.

Unfor­tu­nate­ly, the boom in trans­vagi­nal mesh kits may be based on a defec­tive sur­gi­cal the­o­ry. Tom Mar­go­lis, a Bay Area pelvic sur­geon who spe­cial­izes in remov­ing mesh, paid his own way to tes­ti­fy before an FDA meet­ing last Sep­tem­ber. He tes­ti­fied that the use of syn­thet­ic mesh for trans­vagi­nal repair of pelvic organ pro­lapse con­tra­dicts core prin­ci­ples of surgery. The vagi­na is a clean-con­t­a­m­i­nat­ed sur­gi­cal field, which means that unlike the skin of the abdomen, it can’t be ful­ly dis­in­fect­ed before surgery. Infec­tion is a risk for any type of implantable device. Pass­ing a porous mesh through a con­t­a­m­i­nat­ed field is an invi­ta­tion to infec­tion. Mar­go­lis says trans­vagi­nal mesh vio­lates the Gold­en Rule of Surgery: ​“You shall nev­er implant a syn­thet­ic object into anyone’s body, any­where, if it’s contaminated.”

Daniel Elliott, a uro­log­ic sur­geon at the Mayo Clin­ic in Rochester, Minn., who co-signed a peti­tion by Pub­lic Cit­i­zen call­ing on the FDA to take POP mesh off the mar­ket, wrote in a pub­lic let­ter last August, ​“All too fre­quent­ly, indus­try know­ing­ly tar­gets less expe­ri­enced sur­geons, know­ing these mesh kits have not, and nev­er will be, accept­ed by more expe­ri­enced sur­geons who are ful­ly aware of their inher­ent risk with­out benefit.”

All surgery for pelvic organ pro­lapse has risks. How­ev­er, mesh has a unique risk of com­pli­ca­tions due to a phe­nom­e­non known as ​“ero­sion.” With­in a year, in about 10 per­cent of patients, the mesh can work its way to the sur­face of the vagi­na, or into anoth­er tis­sue plane where it isn’t sup­posed to be. Mar­go­lis argues that most ero­sion is dri­ven by infec­tion. In many cas­es, the mesh is like a giant, fes­ter­ing splin­ter, attempt­ing to work its way out.

Mar­go­lis sees patients with mesh that has become an infect­ed for­eign body ooz­ing foul-smelling dis­charge. Some have done dam­age to adja­cent organs from the mesh itself cut­ting into oth­er organs.

He puts it this way: ​“It’s like a slow death sentence.”

Enmeshed in pain

When mesh works its way out through the vagi­nal wall and extrudes into the vagi­na, a woman can expe­ri­ence excru­ci­at­ing pain. Exposed mesh is also a haz­ard for her male part­ner. Dur­ing inter­course, exposed mesh can lac­er­ate his penis.

“It is more like a cig­a­rette burn that leaves the entire vagi­nal wall red and inflamed, and each step you take rubs the open wound against the oth­er side,” 54-year-old Janet Holt told the FDA meet­ing in 2011. ​“It is com­plete tor­ture.” She described how her mesh shrank by a third, fold­ed in half, and abscessed at the creas­es between her legs and her groin.

An analy­sis for the Sys­tem­at­ic Review Group of the Soci­ety of Gyne­co­log­ic Sur­geons of 110 stud­ies and 11,785 women found that mesh erod­ed in about 10 per­cent of patients. Of the patients with ero­sion, 21 per­cent were suc­cess­ful­ly treat­ed with estro­gen cream, 11 per­cent had pieces of mesh cut out in a doctor’s office, and 56 per­cent had suc­cess­ful removal surg­eries the first time around. The remain­ing 23 per­cent need­ed two or three surg­eries to get the mesh out. Lana Kee­ton, the founder of the patient advo­ca­cy group Truth In Med­i­cine, notes that some women need even more surgeries.

Once in, mesh is very dif­fi­cult to remove. Mar­go­lis has per­formed more than 100 sal­vage surg­eries to remove mesh. He likens the task to get­ting rebar out of set con­crete with­out dam­ag­ing any of the sur­round­ing water mains or elec­tri­cal cables – an almost impos­si­ble task. It is painstak­ing work, and occa­sion­al­ly, he is forced to set­tle for par­tial removal, as some of the mesh is too deeply embed­ded to remove safely.

Even when mesh is suc­cess­ful­ly removed, the chron­ic pain does not nec­es­sar­i­ly go away. And one study found that some patients with mesh repairs are more like­ly to devel­op new uri­nary incontinence.

Many women will have good out­comes with or with­out mesh. Pro­po­nents of mesh say that the grafts cre­ate more durable repairs than non-mesh surg­eries, and that non-mesh repairs have a high fail­ure rate. A large ret­ro­spec­tive study from the pre-mesh-kit era found that 29 per­cent of women who had surgery for pelvic organ pro­lapse or incon­ti­nence had to have at least one re-oper­a­tion. Mesh advo­cates also say that try­ing to rearrange pro­lapsed pelvic organs using only native con­nec­tive tis­sue, which tends to be weak­er in women with pro­lapse to begin with, can be an exer­cise in futil­i­ty. (Skep­tics like Elliott insist skilled sur­geons can treat any can­di­date for surgery with­out mesh, and there­by elim­i­nate the risks of mesh-induced com­pli­ca­tions.) Jeff Secun­da, a vice pres­i­dent at AdvaMed, a trade asso­ci­a­tion rep­re­sent­ing med­ical device man­u­fac­tur­ers, says mesh is an ​“impor­tant treat­ment option” with an ​“estab­lished track record.” He adds that in recent years col­lab­o­ra­tion between the device man­u­fac­tur­ers, doc­tors and reg­u­la­to­ry bod­ies has ​“sup­port­ed and sus­tained patient safe­ty and innovation.”

FDA begins to stir

Mesh repairs are sup­posed to be more durable, but in the last few years, the FDA has become increas­ing­ly con­cerned that may not be the case. In 2011, the FDA ana­lyzed the Medicare data­base and found that of the 212,113 patients who under­went trans­vagi­nal repair for pro­lapse, those who got mesh were 2.26 times more like­ly to need repeat surgery than those who didn’t. How­ev­er, since the study wasn’t ran­dom­ized, it’s pos­si­ble that women already at a greater risk of relapse were more like­ly to get mesh.

In 2008, the FDA warned patients and doc­tors that its post-mar­ket sur­veil­lance was pick­ing up a trou­bling pat­tern of adverse events. By 2011, the agency warned that com­pli­ca­tions from mesh were not rare, and could be seri­ous. In Sep­tem­ber 2011, the FDA held a pub­lic meet­ing to hear opin­ions about mesh reg­u­la­tion. In ear­ly 2012, the FDA ordered mesh man­u­fac­tur­ers to test the safe­ty and effi­ca­cy of their prod­ucts and report back. Mesh prod­ucts that don’t pass the tests could be tak­en off the market.

Reg­u­la­to­ry lapses

So why was mesh approved for use in POP surg­eries in the first place?

The FDA is respon­si­ble for reg­u­lat­ing all med­ical devices on the U.S. mar­ket, from the low-tech tongue depres­sor to the state-of-the-art heart valve. Drugs and med­ical devices are reg­u­lat­ed dif­fer­ent­ly, based on cer­tain assump­tions: Com­pared to drugs, devices tend to have a short­er prod­uct life cycle, may be used by rel­a­tive­ly few peo­ple, and are expect­ed to under­go incre­men­tal changes from one mod­el to the next.

This kind of think­ing makes sense for tra­di­tion­al med­ical devices like pow­er scoot­ers and heart rate mon­i­tors. It’s more prob­lem­at­ic for per­ma­nent­ly implantable devices like pelvic mesh or arti­fi­cial hips — very few of which were on the mar­ket when Con­gress set up the cur­rent reg­u­la­to­ry frame­work for med­ical devices in 1976. A drug might wear off in a few hours, but trans­vagi­nal mesh is sup­posed to last a lifetime.

Mod­er­ate-risk (Class II) and high-risk (Class III) devices must pass an FDA review before they go on the mar­ket, which can be accom­plished by one of two ways: The man­u­fac­tur­er may sub­mit evi­dence that the device is safe and effec­tive, or it may sub­mit evi­dence that the device is sub­stan­tial­ly equiv­a­lent to anoth­er prod­uct (known in the busi­ness as a ​“pred­i­cate”) that is already on the mar­ket. The lat­ter approach, referred to as 510(k), is much quick­er and cheap­er than the for­mer, and accounts for more than 90 per­cent of med­ical devices cleared for market.

The 510(k) process was orig­i­nal­ly intend­ed for low­er-risk prod­ucts like sur­gi­cal gloves and hear­ing aids. It was not designed to eval­u­ate safe­ty and effec­tive­ness because it was sup­posed to be for minor upgrades to low-risk devices that had already been shown to be safe.

Polypropy­lene mesh has been used since the 1950s for her­nia repairs. In the 1970s, gyne­col­o­gists began exper­i­ment­ing with mesh for POP repairs. In 2001, the FDA — with­out review­ing clin­i­cal data or proof of safe­ty and effi­ca­cy – deter­mined that sur­gi­cal mesh intend­ed for POP repair was sub­stan­tial­ly equiv­a­lent to sur­gi­cal mesh for her­nia repair. Two years lat­er, the FDA approved the first syn­thet­ic mesh kit for POP.

“510(k) is an out­ra­geous choice for any kind of implant­ed med­ical device,” says Diana M. Zuck­er­man, pres­i­dent of the Nation­al Research Cen­ter for Women & Fam­i­lies, an advo­ca­cy group that has been urg­ing the FDA to get trans­vagi­nal mesh off the market.

The stan­dard for 510(k) clear­ance is sub­stan­tial equiv­a­lence. The rea­son­ing goes some­thing like this: If Device A is safe and effec­tive, and you can show that Device B is a lot like Device A, then it may be safe to assume that B is safe and effec­tive as well.

That sounds rea­son­able until you con­sid­er that Device A may nev­er have been shown to be safe or effec­tive in the first place. Some devices were on the mar­ket before 1976 and were grand­fa­thered into the new sys­tem of regulation.

A device can even serve as a pred­i­cate even though it has been shown to be unsafe. Under cur­rent law, the FDA must accept Device A as a valid pred­i­cate even after it has been recalled for defects that endan­ger patient health and safe­ty. As long as the intend­ed use and tech­no­log­i­cal char­ac­ter­is­tics are the same, the FDA can’t refuse to grant sub­stan­tial equiv­a­lence to B based on defects in A’s design.

The prob­lems of the sys­tem are obvi­ous. For exam­ple, mesh prod­ucts are on the mar­ket today (such as Ethicon’s Gynecare TVT) that were cleared based on their sub­stan­tial equiv­a­lence to the Pro­te­Gen blad­der sling — which was with­drawn in 1999 after hun­dreds of women report­ed severe pain, life-threat­en­ing infec­tions and neu­ro­log­i­cal com­pli­ca­tions. The Pro­te­Gen sling had orig­i­nal­ly been approved in 1996 when it was deemed sub­stan­tial­ly equiv­a­lent to an ear­li­er mesh prod­uct used for car­dio­vas­cu­lar surgery.

All sur­gi­cal mesh is cat­e­go­rized as Class II (mod­er­ate-risk). Pre-amend­ment devices in Class I (low-risk) and Class II — like her­nia mesh­es — were nev­er com­pre­hen­sive­ly eval­u­at­ed by the FDA for safe­ty and effectiveness.

The FDA is cur­rent­ly con­sid­er­ing whether to reclas­si­fy trans­vagi­nal POP mesh as a Class III device. FDA spokesper­son Michelle Bolek explained that if this mesh is reclas­si­fied, all mesh prod­ucts, includ­ing those already on the mar­ket, will have to apply for pre­mar­ket approval. Pre­dictably, the indus­try is resist­ing the move, insist­ing that the exist­ing con­trols on Class II devices are suf­fi­cient to pro­tect the public.

The Oba­ma FDA deserves praise for tak­ing action on trans­vagi­nal mesh, but the strug­gle illus­trates why the reg­u­la­to­ry frame­work for med­ical devices needs to change. If trans­vagi­nal mesh­es had to demon­strate their safe­ty and effec­tive­ness before going on the mar­ket, the FDA wouldn’t be play­ing catch-up to rein in a prod­uct that has already hurt tens of thou­sands of women.