Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: WEDNESDAY, January 8, 1992 TAG: 9201080140
SECTION: VIRGINIA PAGE: B-1 EDITION: METRO
SOURCE: CHARLES HITE MEDICAL WRITER
DATELINE: LENGTH: Long
WESTERN VA. DOCTORS CONDEMN IMPLANT HALT
The Food and Drug Administration has gone too far in asking that no silicone-gel breast implants be done while more safety studies are conducted, several Western Virginia surgeons said Tuesday."I am sick about this from the bottom of my heart," Dr. Enrique Silberblatt, a Roanoke plastic surgeon, said of the FDA moratorium.
The decision to ask for a temporary halt on silicone-gel breast implants "has not been done in a scientific manner but more of an emotional manner," Silberblatt said.
The ban will "probably cause more harm than good" because it will discourage women from seeking a procedure that has benefited thousands and thousands of women over the past 30 years, he added.
"I think it's a great shame," said Dr. Michael Bestler, a Martinsville cosmetic surgeon who does more than 100 breast-augmentation procedures a year. "This procedure is wonderfully safe and easily performed. It's become the victim of hysteria."
Besides asking doctors to stop performing silicone-gel implants, the FDA also asked manufacturers to stop supplying the implants until an advisory panel recovenes within 45 days. The panel recommended in November that the implants remain on the market while manufacturers collected more data.
However, FDA Commissioner David Kessler said Monday that since then, new information - including evidence of ruptures and increased risk of immune-system disorders - has come to light. There also have been charges that the implants might be linked to cancer and chronic inflammatory disease, although none of the links has been proved.
The FDA moratorium does not affect saline-filled breast implants.
Three producers of silicone-gel breast implants are grudgingly heeding the call for a moratorium. Spokesmen for the manufacturers said the safety analysis will vindicate the devices.
The FDA never before has urged a moratorium on a device so widely used. About 1 million women have received implants in the past 30 years; about 10,000 get them each month. About 80 percent are cosmetic surgery. The remainder are to replace diseased or damaged breasts.
"It appears Dr. Kessler doesn't want to take the advice of his own advisory committee," said Dr. Raymond Morgan, chairman of the Department of Plastic Surgery at the University of Virginia.
Morgan said breast-implant surgery had become an "emotionally charged issue" in part because of high profile coverage of the "relatively few" women who have complained.
Fueling the controversy, he said, are lawyers interested in bringing product liability suits against manufacturers of implants. Last month in California, a federal jury awarded $7.34 million to a woman who claimed her implant had ruptured.
It is puzzling and frustrating, Morgan said, that Kessler didn't give any details of the "new evidence" that in part prompted his moratorium. Morgan said he believes Kessler should have followed the committee's recommendation to allow continued use of the implants, especially in view of the fact that no studies have conclusively linked the implants to cancer or immune system disorders.
"You would think that after 30 years and more than a million implants that something would turn up," Morgan said.
Silberblatt acknowledged that some women do have problems with implants. The most common, he says, is a condition in which the fibrous matter that forms around the implant becomes hard, lumpy and sometimes painful.
Some radiologists complain that implants can interfere with the early detection of breast cancer because they make mammography and interpretation of mammograms difficult. But Silberblatt said new techniques can allow radiologists to overcome most of these difficulties so that having implants adds only a slight increased risk in detection of cancer.
Questions raised about a possible link between silicone-gel implants and cancer or other serious diseases are highly speculative, Silberblatt said.
"I'm not saying these questions should not be brought up. They should be brought up," Silberblatt said. "I support the concept of further investigation. The question is, are these questions enough to make it impossible to undergo breast reconstruction?"
While patients still have the option of using saline implants, Silberblatt fears that those, too, might soon be banned because they have a silicone coating. He said the silicone coating is hard, not soft like the type of soft silicone used in gel implants.
"Nearly everybody's exposed to silicone," Silberblatt added, noting that silicone is used to coat needles and syringes to make injections less painful and is used in pacemakers, artificial joints and other devices implanted in the body.
The ban should not have much of an economic impact on his practice, said Silberblatt, who estimated somewhere between 5 percent and 10 percent of his patients received breast implants.
But breast reconstruction is an area in which Silberblatt feels he "improves the quality of people's lives. It would be a shame not to be able to offer it."
Surgeons say they will go along with the moratorium, but some worry the review process will become bogged down and create unnecessary fear and confusion.
"Personally, I'm not sure it's in women's best interest," Dr. Carol Reichel, a plastic surgeon at Lewis-Gale Clinic, said of the moratorium. "It's creating a lot of alarm, maybe for no reason."
The new evidence that prompted the FDA ban should be made public, Reichel said.
"I have no idea what that information is," she said. "That's the key to the whole thing. No one knows what the information is and what it means."
The Associated Press also contributed to this report.