Untested medical devices facing FDA crackdown Lens, knee implants could be restricted


WASHINGTON -- The head of the Food and Drug Administration is making clear to manufacturers of more than 100 untested medical devices already in use that they must present data from rigorous safety tests or face restrictions on their products.

Like breast implants, which were restricted earlier this month, these products were in use before 1976 when a law went into effect governing federal approval of new medical devices. The law also required federal review of the older products but set no timetable for that. Now, FDA Commissioner David A. Kessler is making a priority of such reviews.

Among the products now facing scrutiny are implants for the testes, shoulders and knees, electrical brain stimulators, balloons that open arteries and lens implants for the eye.

A top agency official said yesterday: "We are becoming more rigorous. These untested devices need attention. Drugs may be in your system for a day or a week, but many devices are in for good."

The official said the agency would review not only the devices that came before the 1976 law, but also many that received less than rigorous scrutiny when the agency approved them in the late 1970s and early 1980s.

Untested devices are worrisome because it is widely believed that the reporting of adverse reactions to drugs and devices is poor, making it possible that some devices have caused substantial health problems that have gone unrecorded and unstudied.

That is largely because doctors have not been required to reportsuch instances, although they will be this year when an unrelated regulation goes into effect.

An example is the Bjork-Shiley heart valve, which was taken off the market in 1985. The valve had been on the market for about six years but was voluntarily removed after public reports of problems. Later, investigations by Rep. John Dingell, D-Mich., showed that about 400 people died when the valves failed. After that, government approval was rescinded.

Agency officials said no specific reports of dangers with the products were driving the new move for review of these products.

"Why weren't we looking closely at these devices 30 years ago to see what happens in people's bodies?" Mr. Kessler said yesterday. "We must remember that these device laws are only 15 years old and our sophistication is still evolving. We now can ask and answer questions we could never even pose before."

Rep. Henry A. Waxman, D-Calif., who is the chairman of the House Subcommittee on Health and the Environment, said in an interview:

"The breast-implant controversy is a crossroads for the FDA, because it will establish the testing requirements for potentially dangerous medical devices that have remained on the market since before 1976."

But as the FDA found in the gel implant case, it can be very difficult to remove from the market a device that is liked by both doctors and patients.

But in the case of some of the older products, the problem will be even greater if the device saves lives and its manufacturer refuses to do the necessary tests to see if adverse reactions are occurring.

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