vaginal mesh


Vaginal Mesh Study: Complications More Likely With Lower-Volume Surgeons

How do you minimize risk when undergoing surgery, an inherently risky endeavor?

If you happen to be one of the thousands of women facing surgery to treat stress urinary incontinence (SUI) — that uncontrollable leakiness due to weakened pelvic muscles, and yet another injustice of middle-age — there’s one pretty clear path to lower risk: Find a surgeon who performs many, many of these operations.

In a new analysis, Canadian researchers reviewed 10 years of data from nearly 60,000 patients who had vaginal mesh surgically implanted to treat stress urinary incontinence. The study concludes: “Ten years after SUI mesh surgery, 1 of every 30 women may require a second procedure for mesh removal or revision. Patients of lower-volume surgeons have a 37% increased likelihood of having a complication.”

The findings, published in the journal JAMA Surgery, “support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” the researchers write.

In case you’ve missed it, vaginal mesh implants have been in the news lately — and the news isn’t good. In May, a Delaware jury awarded $100 million to a woman who sued Boston Scientific, one of the manufacturers of vaginal mesh devices, for negligence, breach of warranty and fraud. Many more cases are pending and regulators continue to scrutinize the devices.

Patients and advocacy groups have also raised major concerns about the safety of vaginal mesh, the study authors note, citing complications ranging from chronic pain (and specifically, pain during sex) and fistula to erosion of the mesh into the vagina, which can require multiple followup surgeries and, needless to say, emotional and physical distress. More than 50,000 women have joined class action lawsuits related to vaginal mesh complications after SUI and prolapse procedures, the study says.

In an editorial accompanying the new analysis, Quoc-Dien Trinh, MD, a urologic surgeon at Boston’s Brigham and Women’s Hospital and assistant professor of surgery at Harvard Medical School, writes: “Although the lay press has focused on the judicial aspect and the potential financial fallout for manufacturers, little attention has been paid to understanding the factors associated with adverse events after vaginal mesh-based procedures. ”

In an interview, Trinh, who also studies health outcomes and patient safety, said the relationship between surgical volume and outcome is well established; that is, the more you do. the better you are. But while patients tend to shop around for high-volume surgeons when considering very complex procedures, like for cancer or heart surgery, that scrutiny doesn’t always carry over for simpler surgeries. “It’s something that people often don’t think about,” Trinh said, “but the same relationship [high volume equals better outcomes] applies to the less complex, same day procedures. Though the complications from vaginal mesh surgery may not be life threatening, erosions and fistulas, these things can make your recovery and quality of life miserable.”

Of course, Trinh said, it’s sometimes unrealistic for people to demand the very best, most experienced surgeon for every procedure. Continue reading

Lawsuits Move Forward, Brought By Women Hurt By Vaginal Mesh

With all of the complications related to vaginal mesh — which we reported on several years ago — the influential doctors group the American College of Obstetricians and Gynecologists recently issued an article, “What Is New in the Use of Mesh in Vaginal Surgery?” offering data published in the past year on the topic.

One notable point about the implants, used to lift sagging pelvic organs back into place, is that removing a vaginal mesh implant that has been causing problems doesn’t always fix the problems. The article, by John R. Fischer, M.D. of the Department of Obstetrics and Gynecology at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, says:

Complications from placement of permanent synthetic mesh for vaginal prolapse repair are well-documented, but there is little to guide physicians regarding outcomes after surgical removal of trans-vaginal mesh. This is a retrospective review of patients who underwent excision of trans-vaginal mesh owing to complications. The most common issues were pelvic and vaginal pain, mesh exposure, and a bulge sensation…After removal, 51% of patients reported complete resolution of their symptoms, with mesh exposure mostly likely to respond to treatment. Of those who presented with pain, 51% reported persistent pain after excision.

Fischer concludes: “…of the many symptoms that are treated with mesh excision, persistent pain may be the most difficult. Patients with a history of chronic pain may not be ideal candidates for the use of synthetic mesh.”

Dr. Peter Rosenblatt, Director of Urogynecology at Mount Auburn Hospital in Cambridge, Mass., says that use of the mesh implants has, indeed, gone down. In an email, he writes:

There has certainly been a decline in the use of transvaginal mesh to treat prolapse, although many pelvic reconstructive surgeons still offer this treatment to patients who are at high risk of failure from traditional surgical repair of pelvic organ prolapse. The FDA safety update in 2011 raised concerns that some of the complications that are unique to these procedures, especially erosion (or more accurately “exposure”) of the mesh through the vaginal wall, are “not rare” and that physicians needed to counsel their patients about the potential risks of using mesh. Surgeons and their patients should weigh these risks versus the potential benefits of transvaginal mesh, which includes improved anatomic success rates. There is also no question that the ubiquitous and never-ending television ads by law firms have instilled a real sense of fear and apprehension among women who are suffering with these problems.

Meanwhile, myriad lawsuits brought by women who say they were harmed by the mesh implants, made by a Ethicon, a subsidiary of the drug giant Johnson & Johnson, continue.

Earlier this month, a California jury returned a $5.7 million verdict in favor of the plaintiff in a vaginal mesh case, according to a local TV news report.

And a West Virginia jury last year awarded $3.27 million to a woman who underwent surgery to remove a vaginal mesh device, reports the National Law Journal. Continue reading

Consumer Advocates: FDA’s Action On Vaginal Mesh ‘Too Little Too Late’

Public Citizen, the consumer advocacy group that years ago called for tighter restrictions on a type of surgical mesh used to treat pelvic organ prolapse, called the FDA’s latest proposal to increase oversight on the products “troubling both in its scope and timing.”

The group said in a statement that the government agency waited too long to act and that its recommendations may still put women at risk.

Here’s the full statement from Public Citizen’s Health Research Group Director Michael Carome on the FDA’s latest proposal:

Public Citizen welcomes…[the] long-overdue issuance of a proposed order by the U.S. Food and Drug Administration (FDA) that, if finalized, would reclassify surgical mesh for transvaginal pelvic repair organ prolapse (POP) from a moderate-risk device (class II) to a high-risk device (class III). This would subject these devices to a more rigorous approval process that would require manufacturers to submit to the agency premarket approval applications with evidence from clinical trials that the devices are safe and effective. Such an order would implement one of three actions requested in Public Citizen’s August 25, 2011, petition to the FDA, which also requested an immediate ban and recall of all such devices currently on the market.

(wikimedia commons)

(wikimedia commons)

However, the FDA’s action today is troubling both in its scope and timing. First, the agency acknowledged that the safety and effectiveness of surgical mesh for transvaginal repair of POP has not been established and that these devices frequently cause serious adverse events. But the agency has taken no action to immediately remove currently available products from the market, as we requested in our petition, or to warn physicians and patients to stop using these devices.

Second, it is disturbing that the agency has taken so long to begin the regulatory process to reclassify surgical mesh for transvaginal repair of POP Continue reading

FDA Proposes New Restrictions To Address ‘Health Risks’ Of Vaginal Mesh

The U.S. Food and Drug Administration today proposed strict new regulations to address the “clear risks” associated with surgical mesh used to treat vaginal prolapse in women.

Specifically, federal regulators want to reclassify surgical mesh as a “high-risk” medical device (it’s now in the “moderate-risk” category) and also impose more requirements on manufacturers in which they must demonstrate that the device is safe and effective.

The risks and health problems related to this type of surgical mesh, which we’ve detailed here, include infections and nerve damage that can occur when the material erodes through the vaginal lining, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and an end to a women’s sex life.

Here’s the full FDA news release:

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” Continue reading

Study: Common Surgery For Prolapse Fails Nearly 1 Out of 3 Women

We’ve written a lot about the scary complications associated with vaginal mesh, synthetic devices that are surgically implanted to treat women suffering from prolapse. This condition, which afflicts millions of women after childbirth or as they age, occurs when stretched or weakened pelvic-area tissues give way, allowing the bladder or other organs to sag or bulge into the vagina.

Now, adding to the mounting data on the potential risks of prolapse surgery in general, a new study in the Journal of the American Medical Association finds that a common surgical treatment for prolapse — one considered the “gold standard” involving abdominal surgery — fails nearly 1 out of 3 women.

So why does prolapse surgery matter? As the JAMA study authors note, nearly 1 in 4 woman have at least one pelvic floor condition and “more than 225,000 surgeries are performed annually in the United States for pelvic organ prolapse.” So, any woman considering this surgery should be aware of the “long-term risks of mesh or suture erosion.” Continue reading

Report: J&J To Stop Selling Controversial Vaginal Mesh Implants

Pharmalot reports that drug maker Johnson & Johnson will halt sales of several vaginal mesh implants that have been the subject of lawsuits in which women charge that the devices led to painful and debilitating long-term complications. Ed Silverman writes:

In an unexpected move, Johnson & Johnson’s Ethicon unit will halt marketing of four vaginal mesh implants that have been the subject of lawsuits filed by approximately 1,000 women who claim the products have caused serious internal injuries. The devices treat incontinence and pelvic organ prolapse in which internal organs slump into the vagina.
The decision involves four Gynecare products – TVT Secur; Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and the Proflit MTM Pelvic Floor Repair System – and was disclosed in a pair of letters sent late Monday to judges overseeing different batches of lawsuits – a federal judge presiding over multi-district litigation in federal court in West Virginia and a state judge in New Jersey.

“Ethicon has no present intention to commercialize these products in the future, but it has requested that FDA allow it 120 days to cease commercialization. This time period would permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” the J&J unit wrote the judges.

Silverman got hold of J&J’s letters to the judges, which you can read here and here.

We’ve written about the ordeals of mesh victims like Amy Gezon, here. Continue reading

Fresh Disclosures On Vaginal Mesh Implants

More revelations about the problems with vaginal mesh implants, which we’ve written about here and here.

Bloomberg reports that Johnson & Johnson sold one early version of the vaginal mesh product before U.S. regulators approved it:

Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The U.S. Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
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Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in a March 16 e-mail. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

FDA Orders New Testing On Vaginal Mesh Products, Cites Safety Concerns

The Wall Street Journal reports that the FDA has ordered the makers of vaginal mesh to conduct clinical studies to further track potential side effects and determine whether the products — which have been used in hundreds of thousands of women — are safe.

The Food and Drug Administration is ordering manufacturers of surgical mesh to conduct new studies of the products when used to treat two conditions affecting millions of women—pelvic organ prolapse and stress urinary incontinence— amid concerns about the products’ safety.

The move is the first step toward tighter regulation of the mesh when inserted through the vagina to repair pelvic organs, a less-invasive procedure than traditional surgery. Surgical mesh was initially developed to repair hernias in the 1950s but doctors later adapted the mesh for other uses. Continue reading

What Went Wrong With Vaginal Mesh: The Podcast

Radio Boston ran a short piece on the problems with vaginal mesh earlier this week, but a key voice didn’t make the final cut: Dr. Anne Weber, a urogynecologist, formerly with the NIH, was the lead author of a clinical practice bulletin on pelvic organ prolapse published by the influential professional group, the American College of Obstetricians and Gynecologists.

In the bulletin, published back in 2007 Dr. Weber used the word “experimental” to describe a type of surgery in which synthetic mesh is implanted vaginally to repair prolapse, a condition many women face after childbirth and as they age in which tissues become stretched and weakened and pelvic organs, such as the bladder, can sag or bulge into the vagina. Seven months after the original bulletin was published, it was pulled, and replaced with another bulletin on prolapse, this one with the word “experimental” gone.

Dr. Weber says the revision, which she opposed, was based on some doctors’ fear that insurers would not cover a procedure deemed experimental. “I think ACOG was choosing to protect its clinicians’ insurance incomes over patients’ well being,” she told me in an interview.

You can read more about the controversy, and about why vaginal mesh surgery is now under scrutiny, here.

So, for the record, here’s the full Radio Boston segment, with Dr. Weber’s comments included.

Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh

On a rainy night in early September, six women gathered for dinner at a Macaroni Grill restaurant in Gaithersburg, Maryland. They had come from around the country: Utah, Georgia, Florida, New York, Texas. But their mood wasn’t festive. All six were in town to speak publicly about their personal medical traumas in front of an advisory panel for the U.S. Food and Drug Administration.

Between them, the women figured they had undergone 45 surgical procedures to try to undo the damage resulting from vaginal surgery using synthetic mesh devices. The mesh implants were supposed to free them from the intimate discomforts that millions of women face after childbirth and as they age: pelvic organ prolapse, in which stretched, weakened tissues can allow the bladder or other organs to sag or bulge into the vagina, and stress urinary incontinence, which can lead to involuntary leakage with every laugh or cough. Once implanted, the hammock-like mesh was meant to shore up the supportive pelvic tissues and help keep sagging organs in place.

But rather than fix their problems, the mesh led to a range of far more awful complications. For some, the material eroded through the vaginal lining, causing infections and nerve damage, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and a halt to their sex lives.

“I was in the most horrendous pain I’ve ever experienced,” said Amy Gezon, a 43-year-old mother of three and one of the women who testified before the FDA advisory panel. “I finally ended up in the ER after expressing a desire to end my life just to escape the pain. If I knew one-tenth of the information out there in the literature…I would have never consented to this surgery.”

A Higher-Risk Device

The FDA, which has already detailed the serious complications linked to vaginal mesh surgery in a series of public health alerts – one in 2008 and an update this summer – is now considering reclassifying some of the devices into a higher-risk category that would require more evidence of safety and effectiveness, including clinical studies. Continue reading