J&J Meshes May Need Post-Market Study on New FDA Rules

Makers of vaginally implanted surgical meshes, led by Johnson & Johnson, may have to conduct studies of three years or more on the products if the Food and Drug Administration follows an advisory panel’s lead.

Thirteen panel members told the FDA yesterday the devices should be reclassified as “high-risk” products, requiring more data to stay on the market. Another four said they worried about slowing medical innovation yet agreed the safety and effectiveness of the meshes required more study.

Manufacturers led by New Brunswick, New Jersey-based J&J, and C.R. Bard Inc. of Murray Hill, New Jersey, face about 500 lawsuits from patients who say they were harmed by a transvaginal mesh. The implants were cleared under an FDA process known as 510(k) based on their similarity to existing products, without clinical trials.

“We need to change how we do our premarket evaluations of these products,” said Colin Pollard, director of the FDA’s obstetrics and gynecology devices branch. “We think the current 510(k) paradigm doesn’t work for these products because we don’t think we know enough about the safety and effectiveness.”

Doctors implanted more than 70,000 of the devices in U.S. women last year, threading them through incisions in the vagina to fortify pelvic muscles that fail to support internal organs, a condition known as pelvic organ prolapse.

No Decision Date

The FDA hasn’t decided when it will make a final decision on reclassification, Karen Riley, an agency spokeswoman, said in an interview. If the FDA takes the panel’s advice, it may be three years before final rules are issued, Pollard said. Existing meshes will stay on the market at least until then, he said.

J&J, the world’s second-biggest maker of health products, after Pfizer Inc., fell $1.31, or 2 percent, to $63.64 at 4 p.m. in New York Stock Exchange composite trading. C.R. Bard slipped $3.95, or 4.2 percent, to $89.62.

While the devices’ worth may be proven over time, they should be reclassified “given the paucity of data” on their effects, said Donald Mattison, a captain in the U.S. Public Health Service and a member of the FDA’s advisory panel.

The panel yesterday opened two days of hearings in Gaithersburg, Maryland, to review whether the agency should impose stricter requirements for the devices. The hearing continued today, focusing on meshes used in patients with stress urinary incontinence.


Manufacturers’ representatives yesterday said FDA can require trials and labeling changes for the products while leaving them as “moderate-risk” devices under the 510(k) system. That would provide more scrutiny while allowing companies to avoid some of the added cost and regulatory delays imposed for high-risk devices, said Ginger Glaser, a senior director of regulatory affairs for American Medical Systems. The device maker is a subsidiary of Endo Pharmaceuticals Holding Inc., based in Chadds Ford, Pennsylvania.

Existing studies have shown the devices safe, Piet Hinoul, a director of medical affairs for J&J’s Ethicon unit, told the panel.

“Serious adverse events that are mesh-specific are very low,” he said.

The FDA is weighing a July report from the U.S. Institute of Medicine urging the agency to scrap the 510(k) process for moderate-risk products. The system allows devices such as mesh implants to enter the market if companies show they are “substantially equivalent” to others already for sale.

FDA Control

Reclassifying the products would give the FDA control over trials the companies must conduct, Julia Corrado, a clinical reviewer for the agency, told the panel. Keeping the devices under 510(k) “would mean a new device only needs to be as good as a device currently on the market and we are concerned that is not good enough,” she said.

While the mesh has been used for more than three decades, mainly for hernias, its use “has evolved over the past few years” as manufacturers expanded into other conditions, said Herbert Lerner, acting director of the FDA’s division of reproductive, gastro-renal and urological devices. “As industry modified surgical mesh for these indications, none of the mesh has been evaluated for clinical data.”

If the FDA reclassifies the implants, it will require data on risks and effectiveness before new models can go on sale. The panel also recommended post-marketing studies to gather long-term data on products already on the market.

Three-Year Trials

Clinical trials to test the devices should last at least three years, said Denise Elser, a Chicago-area physician speaking for the American Congress of Obstetricians and Gynecologists, echoing the advice of some panel members. The Washington, D.C.-based group, with 56,000 members, also wants a registry created to follow patients who already have implants, she said at the hearing.

The added regulation for high-risk devices may harm patients by slowing development of better implants, said panelist George Flesh, a pelvic surgeon and clinical faculty member at Harvard Medical School in Boston.

“Meshes have gotten better every couple of years,” he said. He said he worried that “improvements are going to slow down to a crawl.”

The devices work well for some patients, said panel member Cheryl Iglesia, a pelvic surgeon and associate professor at Georgetown University School of Medicine.

“In general, in appropriate hands with appropriate physicians, it’s safe,” she said. “But I just don’t feel it’s ready for prime time. There’s not enough data.”

Recall Urged

The FDA should go beyond new studies and recall mesh implants on the market now, said Beverly Pennington, a wedding consultant from Carrollton, Georgia. Pennington told panelists she’s suffered through five follow-up surgeries since receiving her implant two years ago.

“We were left permanently injured, robbed of our lives as we previously knew them,” said Pennington, 63. “We the injured became your guinea pigs and your post-market trials.”

At today’s hearing, surgeons representing three medical societies said clinical trials have shown mesh works well for treating with incontinence. New devices should nonetheless undergo premarket testing to get FDA approval, said Deborah Myers, president of the American Urogynecologic Society, a Washington-based group representing 1,300 physicians.

Doctors from the American Urological Association and Society for Urodynamics and Female Urology concurred, and said better training for surgeons was key to reducing complications from the products.

Patients who said they’d been harmed by urinary meshes said the problem lies with the design of the devices themselves, and not their surgeons. Amy Gezon, a 43-year-old mother of three from Salt Lake City, said she “seriously considered suicide to escape the excruciating pain” from her implant.