The surgical procedure, to correct pelvic organ prolapse, has left thousands of women in pain, injured, and even disabled. If only their doctors warned them.
Lauren Bancroft*, a 41-year-old married mother of three, knew something was wrong almost immediately after her surgery.
Bancroft was one of 300,000 American women a year who had surgery to correct pelvic organ prolapse (POP), a condition that affects about half of all women who have given birth vaginally. Bancroft received transvaginal pelvic mesh, which has been used in these corrective surgeries since 1996, but which was only approved by the U.S. Food and Drug Administration (FDA) in 2002. According to the FDA, at least 2 million women have been implanted with transvaginal mesh products. In addition, 260,000 women have transvaginal mesh for sudden urinary incontinence (SUI), which impacts millions of women and is even more common than POP. The number of women implanted with TVM in other countries is in the hundreds of thousands.
For Bancroft, unexpected complications derailed her life for several years. “It just didn’t feel right,” she explained. “You know when you’re rushing and you put a tampon in at the wrong angle and you know you have to pull it out and start over because it feels stabby? It was like that. Only it felt like a piece of something rough was there. When I moved a certain way or sat down too quickly, it felt sharp. I kept wanting to pull it out. But of course, I couldn’t.”
Bancroft called her gynecologist who assured her there was a period of healing, as with any surgical procedure, and that her discomfort would ameliorate over the next few weeks.
Except it didn’t. Bancroft became one of thousands of women for whom pelvic mesh was life-altering—and not in the helpful way they’d expected when they had the surgery. For her, there wasn’t a waking moment when she wasn’t writhing in pain: Her vagina became a misery-inducing entity that she wanted to either fix or get rid of.
In the 2000s, transvaginal pelvic mesh was promoted as better, safer and faster than previous surgical options for pelvic organ prolapse—a condition that can be triggered by obesity or a family history of POP, but it most frequently is experienced by women who have had vaginal births, as the result of vaginal tearing. As model Chrissy Teigen shared recently on Twitter and Instagram, giving birth can be brutal: “I can confirm postpartum life is 90 percent better when you don’t rip your butthole.”
POP happens because the pelvic floor muscles, tendons, and ligaments, weakened by pregnancy, are unable to hold the bladder, urethra, uterus, vagina and/or rectum in their proper place. When POP occurs, these organs drop down from their normal positions and press against one another, or in more advanced cases, actually push so hard on the vaginal wall that the vagina protrudes from its opening.
The pelvic-mesh implant, which is the size of a playing card, acts as a small sling to correct the POP and lift everything back up to its proper positioning. Transvaginal mesh became popular because surgery takes a mere 30 minutes and patients usually go home within 24 hours. Traditional POP surgery is much longer and more extensive. These surgeries require reinforcing the front and back of the vaginal wall, lifting the organs that have dropped or been displaced—most commonly the bladder, uterus, urethra and rectum—and reinforcing those with the woman’s own tissue.
The pelvic-mesh implant seemed to be a revolutionary treatment for a common condition impacting millions of women. But it has left thousands of patients with a host of complications that include debilitating pain, injury to soft tissue and internal organs, loss of sex drive, and even permanent disability. Bancroft is among the many women in the U.S., U.K., Ireland, and Australia currently pursuing litigation totaling in the millions in compensation.
While many lawsuits have been settled out of court like those in large tort settlements, in one of several 2017 cases in Philadelphia, a jury awarded $57.1 million to Ella Ebaugh in September 2017. Ebaugh testified that she suffered chronic pain and permanent incontinence because of two Ethicon pelvic mesh implants that eroded into her urethra. Ebaugh required three surgeries to remove the mesh. Ethicon vowed to appeal. Ethicon vowed to appeal.
Ebaugh’s case was important for reasons beyond the hefty award, which included $50 million in punitive damages. According to Ebaugh’s attorney, Kila Baldwin, evidence introduced during the trial asserted Johnson & Johnson intentionally manipulated the literature regarding problems with the products and withheld information about complications and injuries from doctors.
Which raises new questions about the FDA’s role in banning the products altogether.
Other cases in the Philadelphia and New Jersey area as well as in the U.K. brought against Ethicon have also resulted in large punitive damage awards, with judges noting that doctors would not have used the mesh had they known the impact and potential problems.
Google “pelvic mesh implants” or “transvaginal mesh” and a plethora of personal injury attorney sites appear, followed by medical sites with a range of information—none seeming to stipulate that TVM is dangerous or can create lifelong problems for the patient. There are dozens of blog and Facebook sites where women write about their experiences with TVM and that is where women are most likely to discover the fact not mentioned in literature on TVM surgery because, as one gynecological surgeon who performs these removal surgeries, Dr. Ralph Zipper, explains, once implanted, it is very difficult to remove pelvic mesh and even more difficult to find a doctor who will perform the surgery. Zipper notes that women were not informed of the difficulty of removal because mesh manufacturers did not inform their doctors. Some blogs by women are devoted specifically to highlighting doctors like Zipper who performed their removal surgeries.
The Department of Urogynecology at the University of Colorado, Aurora, has a small paper about such removal surgeries, noting, “Transvaginal mesh removal is a technically complex surgical procedure in which surgeons attempt to remove as much of the mesh as possible. Complete transvaginal mesh removal is possible for some women, while only part of the mesh can be removed in other women due to complicated issues from the type of mesh that was originally used.”
Because the mesh almost inevitably migrates, fuses to tissue, or otherwise creates a greater hazard to the woman than her previous POP condition posed, the risk of removing all of the mesh is greater than leaving some of it—or all of it—intact, as Zipper explains. Why aren’t women told about this?
That was one of many questions raised in Britain’s Parliament in mid-April when this issue was raised in detail—which has yet to happen in the U.S. Female members of Parliament addressed the breadth of the problem in the U.K. and how one in 15 women getting the procedure required subsequent surgery–a phenomenal failure rate. One Labour MP, Sharon Hodgson, recounted that her mother had suffered for five years with complications of mesh implantation. Another member Emma Hardy was succinct: “During the last nine years, the figures show the number of women having the procedure has fallen by 48 percent, which to me says an awful lot about what the doctors are thinking about this. These women were injured, these women were ignored, these women are the victims of a scandal.”
There have been no such hearings in the U.S., even though the use of pelvic mesh in America has not only been standardized for two decades, but the volume of women having the procedures is vast—a half million per year getting POP or SUI surgery compared with about 50,000 in the U.K.
Yet surgeons—perhaps for fear of lawsuits or because they are already being sued—are loathe to discuss it. Several gynecologists contacted about this story declined to speak on the record about it. Perhaps this is because TVM is everywhere: At least 2 million American women have the implants and no one can predict why some surgeries succeed and others do not. (In the U.K. some women and doctors argued passionately to retain the use of TVM.) Nor is there any means to determine if women are just not coming forward or not being believed by their doctors, as was raised in the Parliamentary debate over the procedure. How many women are simply suffering?
More than a year after her initial surgery, Lauren Bancroft had the pelvic mesh removed as completely as was possible. It was a surgery she had to beg her doctor for, bringing her husband with her to the gynecologist’s office to help plead her case. By the time it was finally out, the mesh had perforated her vaginal wall, leaving her with a small fistula, and had nicked her urethra and bladder. Like the majority of patients seeking mesh removal, Bancroft required reconstructive surgery to repair the fistula and the tears in her urethra and bladder.
The University of Colorado paper on mesh removal notes that “in the past several years, there was an increase in the use of synthetic and biologic mesh for transvaginal prolapse surgery. This was largely driven by the availability and marketing of commercially available pre-packed mesh delivery systems or ‘mesh kits.’” Since studies indicate women who have the POP surgery are likely to need it again after five or more years, these “mesh kits” were attractive to surgeons and incentivized the pharmaceutical industry promoting the product.
The FDA’s response to transvaginal mesh is an example of the agency’s valuation of women’s health. What is likely to become the largest product liability case in U.S. history after asbestos and the Dalkon Shield IUD, has yet to be fully addressed by the FDA. Which begs the question of whether the FDA is working for Americans or with the pharmaceutical industry—or if the lines are a little too blurred to be sure.
In July 2011, the FDA issued an alert regarding the use of transvaginal mesh stating that there were increased risks associated with the device. In January 2018, based on numerous reports as well as scientific studies on adverse events directly related to the use of transvaginal mesh, the FDA updated its alert to read:
“1.) Serious complications associated with surgical mesh for transvaginal repair of POP are not rare; and 2.) it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.”
That was it. Not “thousands of women have experienced life-altering complications,” but simply, “not rare.” Not even an alert in the affirmative, which would have given the message a wholly different tone of direct warning rather than implying these complications were rare and few women experienced them.
If you were to travel back a decade into the archive, you’d discover the alarm bells should have sounded loud and long. In fact, Bancroft might not have had that procedure at all, because POP is a corrective and mostly elective surgery. Discomfort, bleeding, difficulties in urination, complications with penetration during sex—these are the reasons women have the surgery. It rarely involves anything life-threatening.
So if transvaginal mesh is not a life-saving device worthy of the risks, why hasn’t the FDA banned it, as Australia, New Zealand, and the U.K. already have?
“The evidence for long-term efficacy is inadequate in quality and quantity,” read the official statement from the U.K.’s National Institute for Health and Care Excellence. “Therefore, the procedure should only be used in the context of research.” Instead, sales of TVM products by manufacturers such as Boston Scientific and Johnson & Johnson hare surpassed $9 billion.
In a 60 Minutes interview in May, Dr. Michael Margolis, who has removed 350 mesh implants and is one of the few experts in the country willing to discuss how catastrophic this is for women, raised issues the FDA has not, including a point that has been stressed in lawsuits: Where the American Urogynecological Society asserts plastic mesh is “safe and effective,” Margolis, says when he has removed the mesh it has completely altered its physical characteristics.
A huge problem for a device that is implanted in the patient for life.
Transvaginal mesh has been under scrutiny since 1996, when the first prototype was fast-tracked by the FDA. Margolis testified before the FDA’s advisory panel about pelvic mesh in September 2011. At that time Margolis warned that mesh was “untenable” due to the inability to create a sterile environment in the vagina, which naturally has bacteria to maintain its own Ph balance.
There is a Kafkaesque quality to the transvaginal mesh debate and the FDA is at its locus. Why is TVM still being marketed even though there are 100,000 lawsuits–thus far–against manufacturers and doctors from women whose suffering has been, according women like Lauren Bancroft and Ella Ebaugh, life-altering? Margolis testified before the FDA seven years ago. Now he’s removed more than 350 mesh implants from suffering women.
How long will this continue?
Ask women who had the Dalkon Shield IUD. That device caused the largest tort liability case since asbestos up to this point (the transvaginal mesh liability is on target to exceed that case) and prompted Congress to expand FDA approval to cover IUDs. In 1976, Congress passed the Medical Device Amendment, which strengthened the FDA’s control over medical devices.
The Dalkon Shield remains a notorious example of a product marketed to women as a health benefit that did tremendous damage to thousands of women, leaving many sterile or with other permanent injuries. Some women died from infections caused by the device.
The IUD went on the market in 1971 to much hype. It was worn by 2.5 million women in the years it was on the market. But by 1973, the Centers for Disease Control (CDC) had begun to receive reports that women were being injured and hospitalized as a result of the Dalkon Shield. A survey on IUDs by the CDC, estimated that 7,900 women had been hospitalized for adverse events of all kinds from ectopic pregnancies to sepsis in just the first six months of 1973. By 1975 the Dalkon Shield was off the market, hundreds of thousands of women were suing and the company went bankrupt in 1985. What’s more, as Ms. magazine reported in 2012, the stigma attached to IUDs because of the Dalkon Shield was lasting—it’s taken more than 40 years for the “fit it and forget it” method of birth control to become popular again.
Is the FDA any more concerned about how women are treated by drug and device companies than they were in 1970 with the Dalkon Shield? Nearly 50 years after that IUD was aggressively marketed to high school and college girls, there shouldn’t be another equally egregious medical device scandal involving only women.
And yet here we are.
What is the FDA doing wrong? The FDA reviews, approves, and regulates all drugs and medical devices in the U.S. The approval process for drugs is 12 years, but the approval time for devices like pelvic mesh, is much shorter—three to seven years. And the trial process is much less stringent.
And much more expensive.
If there is a place where the lapse in oversight can be found, it is here: with how devices are approved. With all such FDA approvals there is a level of risk. If a device helps a preponderance of people in a given trial, then it receives approval. If some either are not helped or are harmed, it’s considered acceptable risk because the majority receive help from the product.
In 2016, Dr. Gail Van Norman addressed the issue of acceptable risk in a paper for Science Direct, where she discussed the process by which devices are approved. In clinical trials, certain products are held to much less stringent processes than others: Class I and II products—mesh falls into these categories—are not required to sustain life, like products in Class III, such as pacemakers. As a consequence, risk levels are deemed to be low to start.
What is also true of devices like pelvic mesh is the there are few “new” devices. Most are “re-purposed” older devices. In the case of transvaginal pelvic mesh, the product was initially used for hernia repair—a very common surgery—and was approved in 1989 for this function. Repurposing mesh for transvaginal repair and/or to repair stress incontinence seemed a simple enough process and one surgeons were eager for.
According to Norman’s research, this process “Typically takes two to three years and costs between $10 million and $20 million. Largely because of these costs, today most truly new medical devices arise out of venture-backed startup companies rather than academic medical centers.” Think Theranos, which falsely claimed to have found a way to test blood with very small samples.
All of which may be how material used for backyard fencing ended up in the vaginas of millions of women without being tested on them. The FDA’s 501k clearance loophole allows previously approved devices to be used in alternative ways. But abdomens and vaginas have different properties as Margolis reported to the FDA in 2011.
The unholy Venn diagram of Big Pharma, the FDA, and the media haven’t so much actively conspired against women as they have ignored them. Most drugs and devices aren’t tested on women or even female animals in early trials. There are illnesses that impact women much more frequently than men, such as multiple sclerosis, lupus, rheumatoid arthritis, yet even these diseases don’t get majority women in clinical trials.
In 2009, when another death due to blood clots in a woman using Yaz was reported, Dr. David A. Grimes, a professor of obstetrics and gynecology at the University of North Carolina medical school, and a paid consultant to Bayer, said of the up-tick in blood clots from the drug, “My dictum is that a multiple of a rare event is still a rare event.”
Fifty years after the Dalkon Shield, are IUDs any safer? In April, Women’s Health magazine lauded Mirena noting the IUD “is the birth control version of black ankle booties—versatile, durable, and with the added bonus of preventing pregnancy.” The same month, the FDA issued a black box warning for Essure, a non-surgical tubal ligation, and activists like Erin Brockovich are collecting data on women who have experienced adverse effects of Mirena.
More attention must be paid to the pain and suffering of the thousands of women impacted by these under-tested devices. At what point do the multiples of rare events add up to a Dalkon Shield or a transvaginal mesh? At what point does the FDA find it imperative to do more than put bigger warnings on drugs or devices? At what point does 100,000 suffering women and counting seem more than enough to demand that a device be taken off the market entirely?
Every year the companies making these devices make more money while women unknowingly undergo surgery they think will improve the quality of their lives only to discover they have been damaged possibly forever. Attorneys specializing in tort liability make money off medical malpractice cases.
The true bottom line is that women’s bodies are a global money-making industry for Big Pharma and their satellites, while the lives of the women themselves seem less and less valuable.
* Names have been changed to protect the privacy of women
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