Gardiner Harris, New York Times: August 31, 2011

WASHINGTON — After two days of discussion and testimony about silicone breast implants, a top government health official said he had heard nothing to shake his faith in the safety of the widely used implants.

The official, Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said silicone breast implants were safe.

“We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days,” Dr. Maisel said.

There are risks to the implants, however, Dr. Maisel said, including ruptures, a hardening of the area around the implants, the need to remove the implants, scarring, pain, infection and asymmetry. “Women should feel assured that the F.D.A. continues to believe that currently marketed silicone breast implants are safe,” he said.

Some patients and women’s groups who testified at the meeting disagreed.

Diana Zuckerman, president of the National Research Center for Women and Families, a research and education group, told an expert panel that the two companies that manufacture silicone breast implants — Johnson & Johnson and Allergan — had done a poor job of studying patients who got the implants, as the F.D.A. required them to do.

“And without proper data, we still don’t know how safe or effective they are and whether there are certain patients at risk for extremely negative outcomes,” Ms. Zuckerman said.

Dr. Maisel agreed that the studies conducted by the two companies had failed to follow as many patients as the agency had hoped.

One purpose of this week’s meeting was to ask the expert panel what the agency and the two companies should do about that poor follow-up. Some suggested that patients should be paid for participating; others mentioned that doctors should get some money, too.

There was some criticism of the 27-page research form that patients who participate in the study are required to complete and whether it could be shortened. Nearly all expressed hope that a registry could be created that would follow all breast implant patients, but such registries are expensive to maintain and complicated to create.

The committee also agreed that patients should no longer be told that they should get a magnetic resonance imaging test three years after getting implants and every two years following.

The reason for telling patients to get M.R.I.’s is that silicone breast implants sometimes rupture without women being aware, and an M.R.I. can reveal this unseen problem.

But many patients ignore the requirements because M.R.I.’s are expensive and it is not clear what they should do when an unseen rupture is discovered; the risks associated with ruptured implants may not be greater than the risks of the operation needed to take them out.

“F.D.A. continues to believe, as does the panel, that M.R.I. is the gold standard for evaluating breast implants for silent rupture,” Dr. Maisel said. “But there was consensus among the panel that the requirements for ongoing M.R.I.’s should be removed.”

Dr. Maisel promised that the F.D.A. would study whether to follow this advice.

Rita Rubin, MSNBC: June 22, 2011

More than one in five women who had silicone breast implants for cosmetic purposes and half of those who got the implants after a mastectomy needed surgery to remove the implants within a decade, according to a Food and Drug Administration report out Wednesday.

“Recognize that breast implants are not lifetime devices,” says the FDA report on the longest studies on the implant to date. “The longer you have your implants, the more likely it will be for you to have them removed.”

In 2010, U.S. surgeons performed nearly 400,000 breast implant procedures. About three-quarters were for breast augmentation, while the rest were for breast reconstruction. About half the surgeries used silicone gel implants; the other half used implants filled with saline.

Silicone implants were pulled off the market in 1992, after concerns were raised about lack of safety data and worries that leaking silicone was linked to immune-system disease.

But the FDA returned the implants to the market in November 2006 after clinical trials didn’t find a link to feared diseases. Plastic surgeons and some women were clamoring for the return of the silicone versions because they say they look and feel more real than saline, which can ripple because it’s essentially a sack of salt water.

The approval required implant makers Allergan and Mentor to conduct large 10-year studies following up on patient experiences, and Wednesday’s report is the first glimpse at how the breast implants held up.

The FDA says 20 to 40 percent of patients who get silicone implants for cosmetic reasons will need another operation to modify or remove them within 10 years. For women with implants for breast reconstruction, the number is even higher, at 40 to 70 percent. The biggest issue was scar tissue hardening around the implant.

Other complications include implant rupture, wrinkling, asymmetry, pain and infection, the report said. Women with breast implants are also slightly more likely to be diagnosed with anaplastic large cell lymphoma, a rare form of cancer.

Despite the risk of complications, the FDA believes that silicone implants are reasonably safe, the report said.

But women in the studies had a high dropout rate and so other complications or long-term safety issues might be missed, the agency’s report says.

Mentor has three-year data for only one out of every five women in its study, while Allergan has two-year data for three out of every five, according to the FDA’s safety update.

“Low follow-up rates and other study limitations may limit interpretation of the data and preclude the detection of very rare complications,” the agency concluded.

Without knowing why patients have dropped out of the studies, it’s impossible to reach any conclusions about implant safety, says Diana Zuckerman, president of the nonprofit National Research Center for Women & Families in Washington, D.C.

“Did they stop going to the doctor because their implants were removed?” Zuckerman says. “Did they stop going because they died or got very sick? Or are they so happy with their implants that they skipped follow-up visits?”

The FDA has been working with the companies to improve patients’ participation in the studies and will convene a meeting of outside experts to discuss the issue later this summer, says William Maisel, deputy director for science and chief scientist at the agency’s Center for Devices and Radiological Health.

Most women who get breast implants are in their 20s and 30s, and may mistakenly consider breast implants a one-time investment.

“They need to understand they’re going to need many removals and replacements for the rest of their lives,” Zuckerman says.

Alicia Mundy and Jon Kamp, Wall Street Journal: February 15, 2011

Most of the medical devices recalled in recent years because of serious or life-threatening hazards were initially cleared for market through an abbreviated approval system that doesn’t require testing on patients, according to a study in the Archives of Internal Medicine.

The study by a Washington health-research group and the Cleveland Clinic’s Steven Nissen comes after the Food and Drug Administration proposed changes to tighten the faster approval system, known as 510(k), but put off some of its toughest proposals for further study under pressure from device makers.

Of 113 medical devices that were subject to recalls between 2005 and 2009, 80 were allowed on the market through the 510(k) program, the study found. About a third of the recalled devices were cardiovascular products, including several brands of external defibrillators.

“These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices,” said the authors. The lead author, Diana Zuckerman, heads the National Research Center for Women & Families, a group that has advocated stiffer approval standards for medical devices.

The 510(k) process is popular with the industry because it can save time and money in regulatory reviews, and industry lobbyists have been campaigning on Capitol Hill against radical revisions to the program.

The process requires that the proposed device be similar to a product already marketed, and is intended for low and moderate-risk devices.

The industry’s lobbying group, the Advanced Medical Technology Association, or AdvaMed, said the study is flawed because it looks at the number of recalls without comparing that to the number of devices that didn’t have problems. AdvaMed-supported studies say that more than 99% of the devices cleared through 510(k) don’t face recalls.

Overall, the 510(k) program has a “remarkable safety record with extremely low recall rates,” AdvaMed said. […]

A 510(k) costs the FDA an average of about $20,000 per application compared to more than $800,000 for a full device review by the agency, according to the report. A full review includes evaluation of safety-and-efficacy clinical trials. […]

Read the original article here.

Read the original article here.

Alan Mozes, U.S. News: February 14, 2011

Most medical devices recently recalled by the U.S. Food and Drug Administration for posing life-threatening or serious safety risks were initially approved for use by that same agency through an expedited approval process, new research reveals.

The findings call out for an overhaul of the regulatory process, to keep unsafe products from reaching the market in the first place, said the study team, led by Diana M. Zuckerman of the National Research Center for Women & Families, based in Washington D.C.

About one-third of the recalled devices were related to cardiovascular concerns, although the speedy approval process is supposedly reserved for products posing only a low or moderate safety risk, the study authors noted.

Their report is published online Feb. 14 in advance of print publication June 14 in the Archives of Internal Medicine.

“The standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life-threatening,” the authors noted in a journal news release. “Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either Congressional action or major changes in regulatory policy.”

The FDA, however, has already taken steps to strengthen its approval process, according to an agency spokeswoman who noted these findings are not new. […]

Read the original article here.

Richard Knox, National Public Radio: February 14, 2011

You’d think medical devices that get implanted in the body or are used to keep someone alive would have gone through studies in actual humans before being allowed on the market.

But that’s usually not the case. A study in the Archives of Internal Medicine notes that many of the most critical medical devices are allowed on the market without their makers being required to submit results of clinical studies before approval.

And, the analysis finds, most of the Food and Drug Administration’s most urgent recalls in recent years have involved “high-risk” devices that had gone to market that way.

“We found to our surprise that the vast majority of devices later recalled as high-risk and potentially deadly had never gone through clinical trials or inspections,” study author Diana Zuckerman tells Shots.

Of the 113 recalls of “high-risk” devices between 2005 and 2009, Zuckerman and her colleagues found that 80 had been approved through a process called 510(k) that doesn’t specifically require any human trials. The largest percentage of these recalls, around a third, involved cardiovascular devices such as defibrillators and stents.

And another eight of the urgently recalled devices went on the market without any FDA oversight at all, because the agency considered them to pose no risk.

The Stabilet Infant Warmer was one of devices cleared for marketing through the 510(k) process without human studies or safety  inspections, Zuckerman says.

It was marketed to “provide a controlled environment for the care and protection of infants.” In 2009, the FDA told the manufacturer to pull back 6,000 such devices under a Class I recall – the most serious kind — because the faulty device could cause serious injury or death. At least one infant was seriously injured after the device caught on fire.

The new study paid particular attention to recalls of Class III devices — those that “support or sustain human life, are of substantial importance in preventing impairment of human health, or…present a potential, unreasonable risk of illness or injury.”

By law, Class III devices are supposed to go through a process called pre-market approval that requires good clinical trials, just as the drug process does. But in the 20 years that the law has been on the books, only one percent of all medical devices has gone through this stringent process, write Dr. Rita Redberg, the journal’s editor, and Dr. Sanket Dhruva of the University of California San Francisco, in an accompanying editorial.

The reason so many devices get waved through the 510(k) process is clear enough. The FDA doesn’t have the staff or budget to do pre-market reviews on the vast majority of new devices submitted each year.

FDA charges companies a “user fee” of just over $200,000 to do a thorough review — less than a quarter of the $870,000 it costs the agency, on average, to do a pre-market approval. By contrast, pharmaceutical companies pay up to $1.4 million for pre-market approval of a drug.

The price tag for a 510(k) review: only $4,007.

The medical device industry trade group AdvaMed got out ahead of Zuckerman’s study last fall with its own evaluation of device recalls. It noted that of nearly 50,000 devices approved under the loose 510(k) process since 1998, only 77 types have been subject to Class I, or highest-risk, recalls.

“It’s hard to imagine any other regulatory process with as good a record as this,” David Nexon of AdvaMed told the Minneapolis Star-Tribune after the group released that report, which it commissioned from the Battelle Memorial Institute.

Asked how she squares her study with AdvaMed’s, Zuckerman says she agrees most devices haven’t been recalled. “But I’m taking the public health perspective,” she says. “How many people have been harmed by these products? We know that 112.6 million devices have been recalled in the last five years. That’s a lot of products. We know thousands of people have died. And those are deaths that did not have to happen.”

The backdrop to this back-and-forth is a big-deal revamping of medical device regulation that the FDA has proposed.

Zuckerman, who heads a nonprofit consumer advocacy group called the National Research Center for Women and Families, applauds some of the FDA’s proposed reforms. But she says they were watered down from the original form last summer.

Meanwhile, the Institute of Medicine is working on a comprehensive report, commissioned by the FDA, on what’s wrong with medical device regulation. That’s due later this year.