Speeding Up the Recall Process : Health: From leaking breast implants to faulty heart valves, the government moves to offer quicker, stronger aid when patients call for help.

By GORDON MONSON

March 2, 1992 12 AM PT

SPECIAL TO THE TIMES

Lucille Rinaudo says she has been in pain since 1986, when her jaw implant proved faulty.

Rinaudo, 36, of Rochester, N.Y., says the device--installed to help ease problems caused by temporomandibular joint dysfunction, which hinders jaw movement--worsened her condition and caused serious side effects.

“At times I feel like I’m on fire inside my head,” she says.

In 1989, the Food and Drug Administration investigated consumer complaints about jaw implants manufactured by Vitek Inc. of Houston from 1973 to 1988. Later that year, the agency told Vitek to stop distributing the implants because their coating was breaking up under pressure. The loose particles cause bone degeneration in many instances, the agency said.

In 1990, the FDA told Vitek to send a voluntary safety alert to doctors. The company, facing several hundred lawsuits, filed for bankruptcy protection. In 1991, the FDA recalled the unused devices among 26,000 implants that had been distributed and, unsatisfied with Vitek’s efforts to inform patients, took over notification.

That November, the bankruptcy court set up a $20-million fund from liability insurers to handle nearly 3,000 consumer claims. However, none of the money has been awarded.

Rinaudo, who is among those who filed a claim against Vitek, says she has been left with increasing medical woes and bills.

When something goes wrong with an implant, seeking help sometimes has been a plodding, circuitous process. Faulty jaw devices, unsound heart valves, pacemakers with bad wiring, leaky silicone breast implants--all are examples of implant inefficacy that continue to draw national attention.

An estimated 12 million Americans have at least one medical implant; another million or so join them each year.

As the number of implant users grows, the government--including the FDA--is moving to streamline the corrective process.

“(Commissioner David) Kessler has made medical device safety a particular emphasis,” says an agency official, who declined to be identified.

The FDA is acting under 1990 legislation that enables it to get faulty implants off the market more quickly and to penalize uncooperative manufacturers and distributors.

In addition, after scrutinizing the risks of silicone breast implants, the FDA is making studies of older devices a priority. A 1976 law governing federal approval of new devices also required reviews of more than 30 devices already on the market but set no schedule.

One FDA official says the agency also will take aim at devices that have since received approval without strict examination.

Kessler and the FDA, after hearing recommendations to restrict use of silicone breast implants, are expected to make a ruling by the end of April. The agency is reportedly setting deadlines for reviews of other implants as well.

“If a consumer is having a problem associated with an implant, we take a report and send it to FDA (headquarters), the manufacturer or both,” says Rosario Vior of the agency’s Los Angeles office. “If the FDA gets a lot of reports from consumers and physicians, we begin to investigate the problem.”

After reviewing the manufacturer’s safety data, the FDA makes a recommendation on how to remedy the problem.

“Usually, the manufacturers are helpful. They want to maintain the reputation of their company. Of course, there are always exceptions.”

Until recently, FDA officials could request but not demand a recall of flawed devices. If the manufacturer did not cooperate, the agency might issue a warning, then initiate a seizure or injunction by filing a complaint in federal court. Finally, these steps could, at least on paper, be followed by criminal prosecution.

“That required a lot of legal effort,” says Gerald Kuester, a medical device researcher for the Public Citizen Health Research Group in Washington, D.C. “They had to get the Justice Department to go along with it, and they really had to have a good case.”

Many observers, including Kuester, say the Safe Medical Devices Act of 1990, parts of which have yet to be implemented, has strengthened the FDA’s hand in dealing with bad devices and the companies that make them.

“No doubt, it has made a difference,” Kuester says. “FDA now has authority to initiate a recall. They can recall a device--if the problem is a serious one--within 48 hours.”

Indeed, provisions in the new law allow the FDA to order an immediate halt on distribution of devices if there is a reasonable probability of serious health consequences. The agency can also order manufacturers to tell doctors to stop using the device. Within 10 days, a hearing is held to determine whether the product should be kept off the market.

Other provisions, most of which are expected to be in force by year’s end, enable the FDA to fine violators of specific regulations up to $1 million, to require hospitals and surgical facilities to report device failure when it causes or contributes to death or serious injury or illness and to require manufacturers to track certain implants.

“That means device manufacturers will have to keep databanks on patients who receive implants,” Kuester says.

When heart valves manufactured by Shiley Inc. of Irvine--a product on the market before 1976--started breaking down during the 1980s, the FDA wanted the company to notify affected patients. With only sketchy records, however, tracking the implants became a complicated proposition.

“They’ve had a horrible problem getting to everyone,” says Jonathan S. Kahan, an attorney for Washington, D.C.-based Hogan & Hartson, one of the largest law firms representing medical device companies. “They are still trying to locate people.”

In past recalls, getting the word out has been a mix of trickle-down and word of mouth, from manufacturers to hospitals to surgeons to, if all went well, the patients.

“We don’t feel notification through physicians is the best way,” says Public Citizen’s Kuester. “Doctors may not want to be bothered with that. They might be afraid they’ll get sued.

“Anxiety from (direct notification) could cause some problems with patients, but it’s most important that everyone is notified.”

Kahan disagrees: “You don’t want someone with a defective heart valve to get a letter in the mail saying, ‘Something’s wrong, you may die tomorrow.’ You have to be extremely careful in how that notification is worded. It’s better to have a doctor deliver that message.”

Not surprisingly, Kahan says the medical implant industry has been effective in providing quality devices and has reacted responsibly when problems have arisen:

“Overall, with the number of implants performed, reports of failures have been rare. Implant manufacturers have done a good job. It’s the doctors’ responsibility to advise patients of potential complications. . . . There are always going to be device failures.”

One FDA official says she agrees that the majority of implant manufacturers comply with the law but quickly adds that improvement is needed.

Kuester continues to argue for an active FDA and a strong implant recall process:

“Based on past experience, you can’t rely on implant manufacturers to respond quickly to recall their own devices. The FDA needs the authority to mandate recalls. That’s to the benefit of all.”