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. […]

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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. […]

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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.

Associated Press: January 26, 2011

WASHINGTON (AP) – Federal health officials said Wednesday they are investigating a possible link between breast implants and a very rare form of cancer, raising new questions about the safety of devices which have been scrutinized for decades.

The cancer, known as anaplastic large cell lymphoma, attacks lymph nodes and the skin and has been reported in the scar tissue which grows around an implant. The Food and Drug Administration is asking doctors to report all cases of the cancer so the agency can better understand the association.

The agency has learned of just 60 cases of the disease worldwide, among the estimated 5 million to 10 million women with breast implants. The agency reviewed the scientific literature going back to 1997 along with information provided by international governments and manufacturers.

Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site. […]

A handful of researchers have published papers on instances of the lymphoma in breast implant patients over the last three years, prompting FDA’s review. Some research suggests bits of silicone can leak into cells around the implant, triggering the cancer. Even saline implants include trace amounts of silicone to help them maintain their shape.

The lymphoma is an aggressive form of cancer though it is often curable, according to experts. Treatments include radiation, chemotherapy and a bone marrow transplant, if the disease returns. […]

The FDA pulled silicone breast implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.

But in 2006 the agency returned the implants to the market after most studies failed to find a link between silicone breast implants and disease.

The approval came with conditions, including a requirement that the companies complete 10-year studies on women who have already received the implants to study leaks, as well conduct new decade-long studies of the safety of the devices in 40,000 women.

The FDA said the companies have continued to pursue those studies, though several of them have enrolled less than half of the patients needed to make them statistically significant.

Dr. Diana Zuckerman said the studies “will be completely useless unless the FDA can convince the companies to do more to keep women in their studies.” Zuckerman’s group, National Research Center for Women & Families, opposed the FDA’s decision to re-approve silicone implants. […]

Andrew Zajac, Los Angeles Times: January 26, 2011

The Food and Drug Administration announced Wednesday that it has begun investigating the possible connection between breast implants and an increased risk of a rare form of cancer.

Though the number of women who may develop the disease is small, there is apparently no way to identify those who are likely to develop it — making it a source of potential concern to all women with the implants.

Among women who do not have implants, the cancer — anaplastic large cell lymphoma, or ALCL — develops in the breast tissue of about 3 out of 100 million women nationwide.

But among women who do have implants, FDA investigators say they have identified as many as 60 women who have developed ALCL worldwide, out of an estimated global population of 5 million to 10 million women with implants.

The FDA did not provide an incidence number for women with implants who developed the disease in the United States alone.

The agency said the number of known cases was too few to draw a conclusion that implants were linked to the disease.

FDA officials emphasized the small risk and said that women with implants don’t need to do anything more than be vigilant.

The FDA advised women not to change their routine medical care, but it said they should consult a physician if they notice swelling, pain or lumps around implants after postsurgical healing.

“Women who are not showing any symptoms or problems require only routine follow-up…. FDA is not recommending the routine removal of breast implants,” said William Maisel, chief scientist and a deputy director of the FDA’s medical device office.

ALCL is a treatable cancer of the immune system, and its occurrence in the breast does not equate to breast cancer, Maisel said.

“I think there’s reason to be concerned about this, but there shouldn’t be reason for panic,” said Phil Haeck, president of the American Society of Plastic Surgeons. Signs of ALCL associated with implants “are pretty dramatic. There’s a lot of swelling and pain. They won’t miss it,” Haeck said.

To better understand the development of ALCL, the plastic surgeons group has agreed to report all cases of ALCL to a national registry established by the FDA.

The FDA also will ask the two U.S. manufacturers of implants, Allergan of Irvine and Mentor Worldwide Santa Barbara, to update product labeling to include information about ALCL.

“We fully support FDA’s efforts to gather additional data and study ALCL in patients with breast implants,” Mentor said in a statement.

An Allergan spokeswoman said in a statement that when ALCL has occurred, “most of the patients have responded to a variety of treatments, including simple removal of the implant and surrounding scar capsule.”

“A woman is more likely to be struck by lightning than get this condition,” the statement said.

But the head of a leading women’s health advocacy group said that the risk, while small for individuals, is still alarming.

“It raises a red flag about what other immune disease could be occurring that are not obvious,” said Diana Zuckerman, president of the National Research Center for Women & Families.

Zuckerman noted that there have been reports that Allergan and Mentor have lagged in meeting benchmarks for 10-year safety studies of implant recipients required by the FDA. […]

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Lyndsey Layton and John Wagner, Washington Post, January 5, 2011

Joshua M. Sharfstein, the second-in-command at the Food and Drug Administration, is leaving that post after less than two years to become Maryland’s top public health official, Gov. Martin O’Malley said Tuesday.

The offer from O’Malley (D) came two weeks ago after John M. Colmers told the governor that he intended to step down after four years as Maryland’s secretary of health and mental hygiene, Sharfstein said.

“It was not that I was looking to leave or was burned out,” Sharfstein said in an interview Tuesday. “I was committed to the FDA. But opportunities like this don’t come along very often. It’s a really great job at a really important moment in time, and with terrific leadership in the state.

“It was impossible to turn it down.”

The new job, which Sharfstein will start next week, touches a broad array of public health issues, including infant mortality, HIV/AIDS, substance abuse, mental health and implementation of health-care reform.

The FDA had no comment on Sharfstein’s departure, according to spokeswoman Karen Riley.

Sharfstein, 41, led the FDA transition team for the Obama administration and aimed to restore the agency’s public health mission. Critics had complained that the FDA grew too cozy with the industries it regulates during the George W. Bush administration.

Once Obama tapped him to help lead the agency, Sharfstein reviewed the FDA’s approval process for medical devices and drugs. He led an investigation into the controversial approval of a knee surgery device, which resulted in the unusual finding that the FDA had incorrectly approved the device because of political pressure.

Under Sharfstein and FDA Commissioner Margaret A. Hamburg, the FDA has stepped up enforcement, cracking down on deceptive claims by foodmakers, quality problems with over-the-counter pediatric medicines, and producers of caffeinated alcoholic beverages.

Sharfstein also tried to get the agency to do a better job of explaining its actions to the public.

Diana Zuckerman, president of the National Research Center for Women & Families, said Sharfstein “inherited a dysfunctional agency, and he made substantial progress on many fronts. His efforts have saved lives, but there’s a lot more work to be done.” […]

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