Experts Say FDA Should Abandon Approval Process

July 29, 2011 — -- A panel of medical experts said the government should abandon its system for approving most medical devices in the U.S., because it offers patients no assurance of safety.

Right now, the U.S. Food and Drug Administration uses a streamlined review, called 510(k), to approve products that are similar to those it has already approved and are on the market. The streamlined review, used for about 90 percent of medical device applications, including those for knee and hip replacement, takes about 10 months as opposed to the years a more complex review would take.

The Institute of Medicine said in a report released today that the FDA should instead require each device maker to prove the moderate-risk (or Class II) products are safe and effective, and possibly test the devices on actual patients. Last week, the Government Accountability office said that a staggering 83 percent of 700 devices recalled every year are Class II.

Click Here to See if Your Product Was Recalled

"The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one," the institute's report stated. The institute also urged the FDA to invest its resources in developing a new system for ensuring a product's safety.

The FDA said it stands behind the 510(k) approval process because it has helped support a "robust medical device industry in the U.S. and has helped bring lower-risk devices to the market for patients who need them." It will, however, have a public meeting to discuss the institute's recommendations.

The device industry's top lobbying group immediately dismissed the proposal.

"The report's conclusions do not deserve serious consideration from Congress or the administration," said Stephen Ubl, president of the Advanced Medical Technology Association. "It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure."

Artificial hips and knees are now a nearly $7 billion market, with 1 million people getting either knee or hip surgery every year, according to several reports. Many of those patients, however, have had to endure second surgeries, because the devices already inside them were faulty.

Katie Ayers underwent a second surgery in January after she learned that her hip replacement device had been recalled.

"It just really seemed like a joke," she told ABC News in February. "You don't recall parts you put in a person."

But it wasn't a joke -- DePuy Orthopaedics was recalling its medical devices because of a design flaw that could leech chromium and cobalt into her body.

"You put your faith in the doctor and the companies that make these products because they're the experts," Ayers said. "It's just beyond me to think that things can get approved that really don't work. It leaves me speechless."

Doctors themselves say they are always trying to improve the quality of the surgery for patients.

"As a doctor, and as a surgeon, we are always looking for the better apparatus," said Dr. Elton Strauss, chief of adult reconstruction at Mount Sinai Medical Center in New York. "We read what has been tested, we read what we think is going to be an improvement. We read about how this device has been used in other countries."

Diana Zuckerman, president of the National Research Center for Women and Families, found that in 2010 more than 437 million devices were recalled out of fear that they might kill or permanently harm patients.

"It's really a gamble. You hope that the product that you are going to choose or that your doctor is going to choose is safe and is going to last a long time," she said.

Unfortunately, patients don't have a way of knowing for certain that the device being placed inside their bodies is safe. There are, however, some steps that patients can take to protect themselves.

How to Protect Yourself

Demand full disclosureAsk your doctor if he or she is paid by the maker of the implant they're recommending for you. This is a big red flag -- that your doctor may be more interested in promoting the device rather than in doing what's best for you. Check the device maker's website. The device maker must -- by law -- list all the doctorsit gives money to.

Do your homeworkWhat track record does the device maker have? How many recalls? Click here to check.

Click Here to See a List of the FDA's Recalled Products

Newer does not always mean better Is the hip or knee that your doctor recommends new to the market? If yes, ask your doctor to explain why it is better than those that have been tested over time. "If the device has been around for a number of years with a good track record, it probably is quite safe," said Dr. Albert Pearsall, the director of sports medicine at the University of South Alabama. "If you Google the prosthesis or manufacturer and there are no red flags, then probably it's OK."