FDA Plans Safety Reviews of Several Medical Devices : Health: Action on breast implants was a turning point for the agency. Heart pump and testicular and penile inserts will be under scrutiny.

WASHINGTON — The Food and Drug Administration, having reached a regulatory turning point in its controversial review of silicone gel breast implants, now will focus on a host of other medical devices.

Those highest on the list have been ranked “Class III,” meaning that they are believed to carry the most risk and the greatest need for a safety review. Among them are a heart pump, a brain stimulator, saline breast implants, silicone testicular implants and inflatable penile implants.

“We’re going to go at this in a very systematic way,” said Jim Benson, director of the FDA’s center for devices and radiological health. “We’re going to call (for the safety data) of these five straightaway and then identify the next set of priorities.”

Benson said that the silicone breast implant experience taught the agency that manufacturers have been too lax in monitoring the safety of their devices and that closer review by the FDA will be required--and he said it will be forthcoming.

“It was very disappointing to see the companies hadn’t done a better job following up on safety concerns,” he said. “The whole issue of risk / benefit and safety is much more on our minds than it used to be. And it has made calling for those products we consider to be high risk all the more important.”

The field of device regulation revolves around an estimated 1,000 medical devices that came onto the market before 1976, the year Congress approved legislation giving the FDA authority over devices. The law also provided that the manufacturers of products already on the market likely would be called upon at some point to prove that their products were safe--and face a ban on their devices if they failed to do so.

The episode that ended earlier this month with severe restrictions on the use of silicone gel implants was not the first time that the FDA has taken on products that hit the market before 1976. But it was certainly the most public and the most painful--and the one that brought the greatest pressures to bear on the agency.

“It was a watershed,” one agency official said. “From now on, no one else will be sleepwalking.”

Although he was referring to the manufacturers of medical devices--who now must be more scrupulous in gathering safety data and be prepared to prove their products are safe--the same could have been said for the agency itself.

The FDA, slow in the past to demand safety studies from device manufacturers, proved through the silicone breast implant experience that it could be aggressive, despite the pressures, and is expected to maintain that same style in coming months.

“I don’t think anything will be as tough as the silicone implants,” said Benson. “In retrospect, I wish we had acted even earlier. But I think from now on we’re going to take a stronger position.

“There are still incredible resource limitations and we’re influenced by that. But it (the silicone implants experience) made us realize that there are products out there that have to be looked at--and we have to get on with it.”

Fewer than a dozen medical devices have either gone through the process already or simply left the market before the review began, as was the case with intrauterine devices. These included various replacement heart valves, a contraceptive tubal occlusion device--which is a reversible sterilization tube--and an implantable nerve stimulator.

Before the year is over, the agency intends to call for safety studies on at least five products:

--Saline breast implants, which are filled with salt water, are likely to be the first. Like silicone gel implants, they have been on the market for at least three decades, actually predating the silicone gel implants. They generally have been regarded as safer, because when they rupture, they release harmless salt water into the body.

--Testicular implants are made of silicone and are used for cosmetic reasons in individuals who have had their testicles removed for cancer, or other malformations, agency officials said.

--Inflatable penile implants are implanted in an estimated 45,000 men every year, according to the FDA, and are used strictly to remedy physiological--not psychological--impotence.

However, “we have received a lot of adverse reports on these,” said one agency official. “There are a lot of problems with leakage of fluid in the device, and breakage of elements of the device. We’ve got to take a look at those. It was kind of a shocker when we got a handle on the numbers.”

--The centrifugal pump originally was used in heart bypass surgery to keep the blood flowing while surgeons were working on the heart. In recent years, however, it has been used increasingly as a bridge to a transplant, which is a new use and subject to review, agency officials said.

--The cranial electrotherapy stimulator delivers “a mini jolt to the brain and is used by certain practitioners to gently jolt people into getting rid of anxiety, of their neurosis,” one FDA official said.

“The agency will now call for data and be more thorough,” said FDA Commissioner David A. Kessler. He predicted that manufacturers and the medical community also would do a better job reporting the complications they find with devices.

“The whole notion of tracking and following and reporting the problems is the key here,” Kessler said. “We need to recognize that we are not always going to know everything about a device on the day we approve it. We have to be willing to recognize that down the road . . . there may be problems. And we have to be willing to do something about these problems.”