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.
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
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
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
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
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.
The U.S. Food and Drug Administration is proposing tougher regulations for vaginally implanted surgical mesh to treat women with prolapse, The Wall Street Journal reports.
In a document posted to FDA’s website Thursday the agency said, the “rate and severity of mesh-specific adverse events following vaginal POP [pelvic organ prolapse] repair with mesh calls into question the safety of these devices.” Many side effects were caused by the mesh protruding out of the vaginal tissue, which in turn caused pain, infection and bleeding.
The agency said is proposing new mesh products undergo a premarket review process, which requires companies to conduct studies looking at a product’s safety and effectiveness prior to approval. The mesh products are currently reviewed under the less stringent review known as the 510(k) process. The agency is also proposing that studies involving current products be conducted but said it would consider a grace period for companies to submit a premarket approval applications.
An FDA advisory panel is being called on to discuss the mesh products next week. The meeting [Sept.8-9] is expected to mostly focus on mesh when used to treat organ prolapse, but the panel will be asked to discuss the use in treating a condition known as stress urinary incontinence. The consumer group Public Citizen petitioned the FDA last week to recall existing mesh products and require new products to undergo a premarket review process.
In a piece yesterday, I wrote about a group of pelvic surgeons who are challenging some of the FDA’s safety warnings.
Medical Device (Adverse Event) Reports
The debate over a controversial medical device used for women is heating up.
A nationwide coalition of pelvic surgeons is challenging a recent U.S. Food and Drug Administration safety advisory that warns of serious risks, complications and questionable benefits of surgical mesh implanted vaginally to treat women for a condition known as prolapse. The procedure is used to strengthen vaginal tissue that has grown weak or stretched, often after childbirth.
In advance of an FDA advisory panel meeting Sept 8-9 to discuss the safety and effectiveness of the mesh — and as attorneys across the country intensify their efforts targeting the device through litigation — pelvic surgeons say they e-mailed a response letter to the FDA outlining their concerns. A copy of the letter was obtained by CommonHealth.
“We have some significant disagreement with the conclusions reached [by The FDA] and concerns regarding the message that it is sending to our patients, the healthcare community, and unfortunately to the legal community as well,” says the Aug. 25 letter, which is signed by more than 600 pelvic surgeons, according to one of the organizers, Dr. Miles Murphy, associate medical director at the Institute for Female Pelvic Medicine & Reconstructive Surgery and Director of the Division of urogynecology at Abington Memorial Hospital in Pennsylvania. Continue reading