FDA Gears Up for Synthetic Mesh Regulation
SEPTEMBER 10, 2011 – Should synthetic mesh used to treat stress urinary incontinence be upgraded to a Class III high risk device?
The Food and Drug Administration’s (FDA) Obstetrics & Gynecology Devices Advisory Committee met for a second day, Friday, September 9, to consider whether synthetic mesh used to treat stress urinary incontinence (SUI) in women should be upgraded from a moderate risk Class II medical device to a high risk or Class III device.
During Thursday’s session, the first ever FDA critical review of petroleum-based mesh, 13 of the 17-member panel informally decided to reclassifying mesh used for pelvic organ prolapse (POP) to Class III because of the potential for devastating side effects, including mesh erosion, organ perforation, bleeding, debilitating pain and death.
That option would end the fast-track to market that nine mesh manufacturers have enjoyed under the current 510(k) process which allows approval of medical devices for sale with no safety requirements if they are substantially similar to another device already on the market.
Women and Adverse Events
Last July the FDA issued an alert (here) that warned thousands of women have been harmed by mesh used to enforce pelvic organ strength and incontinence or urine leakage, an embarrassing problem that affects an estimated 13 million American women. The FDA data was culled from the agency’s own Manufacturer and User Device Experience (MAUDE) database, a little-known portal offered to injured patients and doctors to report harm. Since it’s so obscure and not user-friendly, it’s thought to represent just a small fraction of actual cases of harm.
And although the SUI mesh is the same petroleum-based mesh used for pelvic repair, the panelists felt the medical device had a better track record with adverse side effects in the 1% to 17% range. That true number is elusive because the current system fails to follow up after surgery and some adverse events don’t show up until many years after surgery.
The panelists asked for more long range data of at least one and up to five years specifically on the mini-sling SUI mesh to get some idea of the extent of injuries.
Adverse Events – Women in Pain
Panelists didn’t need database numbers as women injured by mesh faced the committee to tell their stories on both days. As each woman went to the podium the room grew quiet. Panelists listened intently and some showed a painful expression as the stories unfolded. One man also testified who is disabled following mesh implant for hernia repair.
Amy Gazan, a pretty 43-year-old mother of three from Salt Lake City, Utah, had mesh surgery to treat a pelvic condition. She told the panelists about her long arduous journey in search of meaningful relief, insurmountable medical expenses, referrals, tests, excruciating pain 24-hours a day and no quality of life for months.
“I seriously contemplated suicide to escape the pain,” she told the panel. “Scouring the journals I realize had complications and needed mesh removed. If men had mesh erode through their penis would their complications be dismissed so casually?” she asked the panel.
When it became clear her physician couldn’t help her, Gazan said she went to a physician outside of Utah to have the mesh removed. “Some surgeons blame industry for misleading them women find no solace in this ignorance. I urge the FDA to reclassify mesh, to allow indiscriminate use of mesh for SUI without medical justification is utterly senseless.”
Gazan has written for Yahoo: Pelvic Mesh: A Story of Social Injustice in Public Health (here).
Linda Dodson, a tall attractive woman of 59, had prolapse surgery in 2006 and told the experts she continues to live in pain to this day. Two surgeries followed in 2007 to remove the Ethicon mesh made by Johnson & Johnson. She chastised the FDA for not warning the public in its first safety alert in 2008 and again in July 2011.
Dodson cited the market withdrawal of contaminated dog food after three dogs died, another product regulated by the FDA under the same safety standards that are supposed to be applied to humans.
“Why did the FDA not use the same health standard? The FDA issued dog food recall, is dog’s life more important than humans life?” Dodson asked, her voice shaking. Panelists listened intently. Dodson, who worked in Georgia state government, understands regulations. She said if mesh is not recalled she will charge FDA Commissioner Margaret Hamburg with dereliction of duty.
Deborah Tedford was a journalist overseas with Reuters until as she says she “traded the inconvenience of incontinence for a sling made of transvaginal mesh.”
“It has completely changed every aspect of my body,” she said telling the panelists of unrelenting pelvic floor pain and difficulty urinating.
“Despite the suggestion I had unskilled surgeons or didn’t ask enough questions, that wasn’t the case with me, a long-time journalist with a major media outlet in D.C. I can assure you I asked plenty of questions.”
Tedford, as many other women, assumed the product had gone through pre-market clinical trials and if it didn’t work she could simply have it removed.
But it remains today. Because of the demands of her job, she had to leave the profession she loved. Now, every day is about managing pain. “I know some woman have been helped by these products but I urge you to recommend subjecting it to more study and use it only as a last remedy.”
Diane Massen, an attractive petite woman was in active retirement in Las Vegas in 2005 when she began what she called a “leakage problem”. She had a sling made by American Medical Systems implanted to hold up the bladder because the urologist said it was less invasive than customary bladder surgery.
“The ladies in the video seemed satisfied with the results but the video said nothing about risks,” she told the panel at the podium with her husband standing by her side.
Instead of a three week recovery, Diane said it took her five months to get out of bed. She says her body has tried to reject the sling since day one. She experienced stomach pain, then became incontinent and had numerous urinary tract infections over 4 years. Intercourse has been impossible and she told the panel she goes to the bathroom up to 20 times a day. Most recently a mass the size of a soccer ball was removed from her left kidney along with three liters of fluid.
Mesh for SUI Stay as Class II?
Despite the stories reclassifying surgical mesh to treat incontinence is not warranted. Dr. George Flesh, a pelvic surgeon from Harvard assured the panel, “The benefit versus the risk of this type of surgery exceeds the risk compared to what we did 10 to 12 years ago.”
Panelist concluded more clinical trials for SUI treatments are not needed unless the mesh is different in some way, such as the pore size, composition or structure.
But panel members were concerned about the lack of post operative follow-up on patients, which is not mandated by the agency. For example, when one study showed an active infection in 25% of women five years following SUI surgery, no one within the agency could explain whether that meant a lengthy chronic urinary tract infection or an occasional one.
To answer questions about long term effects, panelists concluded a minimum of a one year follow-up with women up to five years and even longer through a registry that could track patients for decades.
“We need follow-up to the grave if need be,” said Gary Duehring, PhD, the consumer representative on the panel.
Panel member, Barbara Berney, a patient advocate from Rockford, Illinois said, “Part of the problem with finding complications is we’re not looking for them.”
For the second-generation or mini-sling products, panelists called for both pre-market safety and efficacy data as well as post-market surveillance. Invoking the Special Controls of the 510(k) process would allow regulators to create patient registries, issue guidelines for clinical data and labeling as well as submitting data, and creating performance standards. Panel members indicated adding that regulation as part of its final recommendations to the FDA for future action.
New Tougher Training Program Ahead for Device Reviewers
Noticeably absent from the meeting was Jeffrey Shuren, the head of the Center for Devices and Radiological Health that oversees medical devices. Almost on cue, on Thursday, Sept 8, Dr. Shuren was quoted in an article in Cardiovascular Business (here) that the FDA plans to “roll out two new training programs for product reviewers.”
The programs are intended to sharpen the skills of the reviewers including training up to 18 months to handle 510(k) applications. The CDRH has been criticized for being too slow in reviewing the 4,000 510(k) applications that come in every year. Those same employees who have been criticized for not being particularly well-trained, give the 510(k) fast-track approval to about 3,000 medical device applications annually. #