Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: TUESDAY, February 18, 1992 TAG: 9202180181
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
SOURCE: The Washington Post
DATELINE: WASHINGTON LENGTH: Medium
FDA TRIES TO ASSESS IMPLANT HAZARDS
Today, 30 years after the first silicone-filled breast prosthesis was implanted in an American woman, a special committee of the Food and Drug Administration will meet to ask whether the devices are safe enough to remain on the market.They will not get a satisfactory answer. In the three days of hearings, no one will present definitive long-term studies on the questions that interest the FDA most: How often the gel inside these implants leaks outside into the body and what happens when it does? These studies have never been done.
Experts say that in the critical early years after the introduction of implants, no one thought to do basic research into silicone's effects because no one imagined that the material could pose a significant risk.
Manufacturers said they did their own in-house testing of silicone in the 1960s and 1970s and didn't think any broader study was necessary. The FDA, given the power to regulate implants in 1976, didn't even ask companies to submit safety data on them until two years ago.
"The reason we are still resolving this issue 30 years later is that there are a lot of vested interests," said FDA Commissioner David Kessler.
"There are people who think it is safe and people who think it isn't safe. There is tremendous belief on both sides. But there isn't the data."
Instead of definitive evidence, the committee will be given internal memorandums from one of the implant manufacturers, Dow Corning Corp.; an assortment of manufacturing details; anecdotal reports from plastic surgeons and rheumatologists; and the conflicting opinions of a variety of medical experts - against a backdrop of charges and countercharges of lawyers representing women who say they have been harmed by the implants, women's groups, plastic surgeons and implant manufacturers.
"As a scientist I don't feel happy about the way things have developed," said Noel Rose, an immunologist at Johns Hopkins University. "We would all prefer that the information be developed first and the policy made later. This is the other way around."
Why so little is known about breast implants is rooted in a quirk of regulatory history. Had implants been introduced after 1976, they would have fallen under the provision of the medical device amendments passed by Congress in that year. Before they could have been marketed, the manufacturers would have had to present full FDA-mandated clinical studies on their effectiveness.
But because they were introduced in 1962, they came under the grandfather clause in the law - which allowed existing devices to continue to be sold - with the provision that the agency could ask the manufacturers to produce safety data whenever it desired. That turned out to be in 1990.
"If you look at FDA history, whether it is drugs or food additives or medical devices, it has always been the grandfathered products, the ones that have already been on the market, that have taken the agency a long time," Kessler said.
Part of the reason was the sheer number of devices available in 1976. There were some 100,000 medical devices - including heart valves, intrauterine devices and inter-ocular lens - already on the market. Picking through those devices and deciding which needed further scrutiny, FDA officials say, took years.