— Janet Holt figured she simply had an infection “down there.”
But instead of a prescription, her doctor told her she’d need a procedure. Her bladder had slipped out of place, creating an uncomfortable condition known as pelvic organ prolapse, which affects many women as they age.
Her doctor said he could fix it, building a kind of nest or cradle to prop up her insides. Holt doesn’t remember him ever mentioning that he was going to use something called surgical mesh to do the job. But he was the doctor, so Holt, a 50-year-old from San Antonio, Texas, agreed to the operation.
Four years later, however, the medical device that was supposed to fix Holt’s problem has caused a host of new ones, sparking constant pain and requiring seven more operations as other surgeons tried to remove the mesh, which had eroded into her vagina, bit by bit.
Holt has become a poster child for growing concerns about the government process that allows devices such as surgical mesh — made of the same material as Rubbermaid storage containers — to be used with no testing on patients before they’re allowed on the market.
“I don’t think I’m going to get any better,” says Holt, now 54, who has had to cut back on work at her family’s five restaurants and can no longer ride horses or play baseball with her young grandson.
Unlike prescription drugs, which must be proven safe and effective before they’re marketed, most medical devices have no such requirement. Only about 10 percent of devices, those deemed the riskiest, such as breast implants and implantable pacemakers, fall into that category. Surgical mesh, used to support organs that have slipped over time, does not.
That may soon change.
A growing number of reports of surgical mesh-associated complications in women spurred the FDA this month to issue its second warning about the device in less than three years. In September, the agency will convene a panel of outside experts to advise whether surgical mesh should undergo more rigorous testing.
Report will assess safety, innovation
Even as that action is pending, the Institute of Medicine — an independent nonprofit group that advises policymakers and the public — plans to issue a major report Friday about whether the process of approving devices optimally protects patients and promotes innovation in the name of public health.
And it’s not just surgical mesh that’s under scrutiny.
A recent analysis of recalls raised questions about how the FDA clears thousands of devices for market. Published last month in the journal Archives of Internal Medicine, the study examined 113 recalls from 2005 through 2009 of devices that the FDA determined could cause serious health problems or death.
Of those, only 21 of the devices had been required to be tested on patients before receiving FDA approval, found authors Diana Zuckerman and Paul Brown of the National Research Center for Women & Families in Washington, D. C., and Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic.
Manufacturers of another 80 recalled devices had only to show they were similar to devices already on the market to gain approval through the FDA’s 510(k) approval process. The remaining eight recalled devices didn’t have to go through any kind of FDA review. Of the 113 recalls, 35 were for cardiovascular devices, including automated external defibrillators, or AEDs, and only 12 of them had been required to undergo patient testing.
“Consumers are justifiably upset when their cars, toasters, and baby food bottles are recalled,” wrote Dr. Rita Redberg and Dr. Sanket Dhruva of the University of California, San Francisco, in an editorial accompanying the study. “Recalls make us all question the safety of the products we take for granted. But what about the products permanently implanted inside our bodies?”
Patients assume implantable devices are thoroughly tested before they come on the market, Redberg and Dhruva wrote. “It is sad and troubling to learn that we cannot count on this assurance for some medical devices,” they added.
The FDA’s latest warning called complications linked to surgical mesh in procedures such as Holt’s “an area of continuing serious concern.” “Serious complications,” the FDA emphasized, “are not rare.”
The warning specifically addressed mesh placed through the vagina instead of the abdomen to repair pelvic organ prolapse or stress urinary incontinence, urine leakage during physical activity. Pelvic organ prolapse occurs when the tissues holding the bladder, the uterus, the rectum and the bowel in place become weak or stretched out.
It might affect as many as half of all women during their lifetime, according to the FDA, although only a small fraction experience symptoms.
100,000 mesh patients in 2010
In 2010, the agency says, doctors performed at least 100,000 prolapse repairs using surgical mesh, and about three-quarters of them were transvaginal. From 2005 to 2007, the FDA received more than 1,000 reports of adverse events related to the mesh in women treated for pelvic organ prolapse or stress urinary incontinence. From 2008, when the FDA first revealed its safety concerns, to 2010, the agency received nearly 3,000 more.
“Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” the agency stated.
On top of that, there’s no evidence that transvaginal surgical mesh actually provides any benefit. According to the FDA, a review of scientific articles published over the past 15 years found that use of the mesh didn’t improve symptom relief or quality of life when compared to traditional non-mesh surgery for pelvic organ prolapse.
Don’t expect the agency to pull the device off the market, though.
“We don’t think transvaginal mesh should be routinely used for pelvic organ prolapse repair,” says Dr. William Maisel, deputy director and chief scientist at the FDA’s Center for Devices and Radiological Health, “But we do not regulate the practice of medicine, and we do recognize that some patients really do need mesh.”
Dr. Ingrid Nygaard, a urogynecologist with the University of Utah, says she sees about two new patients a week with mesh complications. Some can’t be successfully treated, Nygaard says, “and that’s a big tradeoff for a procedure that has uncertain effectiveness.”
Surgeons who use mesh generally mean well, because other techniques have a failure rate of about 10 percent to 20 percent, she said.
Problem is not just FDA, expert says
Dr. David Grimes is less sanguine than Nygaard about surgeons’ intentions. The problem is not just the FDA’s approval process, said Grimes, who is board-certified in obstetrics and gynecology and preventive medicine and a distinguished scientist at FHI360, a global development organization based in Research Triangle Park, N.C.
“The problem is the surgeons,” he said. “This is industry-driven technology. We have a long history of accepting things without critical appraisal. What we need are better standards not just within the FDA but within the professional community.”
Conducting adequate clinical trials of devices like surgical mesh can be daunting, expensive and time-consuming, experts acknowledge.
As Grimes says, “it’s easier to do studies of pills than it is to do studies of surgical techniques.”
Dr. Cheryl Iglesia, a urogynecologist at Washington Hospital Center in Washington, D.C., tried but had to cut her study short.
In the journal Obstetrics & Gynecology last year, Iglesia and coauthors published findings from a trial in which they randomly assigned 65 women to transvaginal repair of prolapse with or without surgical mesh.
After only three months of follow-up, the researchers found the mesh had eroded in nearly one in six of the women who’d received it. Meanwhile, cure rates and quality of life didn’t differ between the mesh and no-mesh groups, leading the researchers to question the value of the device in such procedures.
However, a spokesman for mesh manufacturer Ethicon, a Johnson & Johnson company, called its use in treating pelvic organ prolapse and stress urinary incontinence “an important option for many patients.”
“Potential complications and risks are disclosed in our product labeling,” Ethicon spokesman Matthew Johnson says, “and discussed in our professional education and promotional literature.”
Three other mesh manufacturers contacted by msnbc.com did not respond: Boston Scientific, C.R. Bard and American Medical Systems, which Holt is suing.
A registry of transvaginal mesh patients would help inform doctors and the FDA, Maisel, Nygaard and Iglesia agree. To avoid skewing the registry toward patients with complications, Maisel says, women would be entered into it as soon as they received transvaginal mesh.
In other words, neither Janet Holt nor any of the tens of thousands of U.S. women already implanted with the mesh would be counted.