Not only are they abusing the judicial system, but they are emotionally abusing the women." That's what one silicone breast implant recipient told the Boston Herald following the decision of Dow Corning to file for bankruptcy. Dow Corning had contributed about half of a $4.2 billion settlementthe biggest everfor women claiming to suffer various illnesses from their implants.
Earlier this year, however, it became clear that there were far more women trying to get a piece of the pie than there were slices. Plaintiffs' attorneys were saying that $74 billion might be needed to satisfy just the first set of claims against the companies. Rather than close its doors forever, Dow Corning chose to try to limit its losses.
Financially, it's unclear where the bankruptcy leaves implant claimants. But what has become more and more certain since the settlement was reached back in 1993 is that while both the judicial system and silicone implant recipients have been terribly abused, the villain isn't Dow Corning or any other implant maker.
Indeed, women with breast implants have been nothing more than pawns in a bizarre game involving lawyers, feminists, headline hounds, and super-inflated bureaucratic egos. The stakes, however, go beyond the physical and mental health of women with implants to include the future health of millions of Americans who will need insertable medical devices. Indeed, the multimillion -dollar awards against silicone implant manufacturers have already triggered a wave of suits against medical implants made of solid silicone and even some containing no silicone at all.
"We have great concerns that any medical device with silicone in it will not survive," says Elizabeth Connell, a professor of gynecology and obstetrics at Emory University and head of two Food and Drug Administration silicone breast implant panels that unsuccessfully recommended leaving the devices on the market. Since June 1992, most uses of silicone breast implants have been banned by the FDA. Annually, some 1.5 million patients receive silicone eye lenses; another 670,000 get artificial silicone joints. All told, about 7.5 million medical devices are implanted in Americans each year. Many of these devicessuch as pacemakers, heart valves, and shunts which draw fluid off the brainare life savers.
Hence, the misinformed campaign against silicone breast implants raises issues that go far beyond the not insignificant question of whether women should be able to change their appearance as they see fit. A strange alliance of diverse interests, including FDA bureaucrats interested in broad ening their powers, feminists who equate boob jobs with mutilation, and reporters more interested in good copy than relevant medical research, worked together to take implants off the market. The anti -implant campaign is nothing less than a case study in how medical public policy is often driven by anecdotal rather than epidemiological evidence, formulated by ideologues who have little regard for what individuals might val-ue, and discussed in a consistently one-sided manner.
The use of silicone implants to enlarge the size of the breast dates back to 1963. Somewhere around one million American women have received them. Implants may be used either for "augmen tation"making a healthy breast or pair of breasts largeror to replace a breast removed during mastectomy. It appears that about 60 percent of breast implants have been used for augmentation.
While there has been mention of possible disease caused by implants as far back as 1978, the kick-off point of the scare that ultimately prompted the FDA to ban silicone implants may have been the airing of an implant feature on CBS's Face to Face with Connie Chung in 1990. Chung's graphic imagery she called silicone gel "an ooze of slimy gelatin that could be poisoning" women spurred one stampede of women to have their implants removed and another to file suits against implant makers.
As Chung herself later put it, the show "unleashed a torrent of protests and investigations around the country." Soon, women were bombarded with such stories as "Toxic Breasts," "The Hazards of Silicone," and "Time Bombs in the Breasts." The height of hysteria may have been reached when, after the FDA moratorium, two women removed their own implants with razor blades. They said they had no success in getting doctors to remove them.
A new front opened up in December 1991, when a California jury awarded a Marin County woman, Mariann Hopkins, $7.3 million from Dow Corning. She alleged aches, pains, and fatigue caused by her implants without citing any illness more specific than autoimmune disease, a catchall phrase for a variety of connective- tissue diseases such as rheumatoid arthritis, scleroderma, lupus, Sjogren's Syndrome, fibromyalgia, and Raynaud's Disease.
In January 1992, the FDA declared a voluntary (but strongly recommended) moratorium on the sale and use of silicone breast implants pending review of additional information, saying, "physi cians should cease using them and manufacturers should stop shipping them." Four months later, the FDA essentially converted this to a ban, although the agency did allow continued use of the implants for women who had suffered mastectomies and permitted a small number of women who wanted implants for cosmetic purposes to enroll in long-term studies.
Like many health scares, the one over silicone implants is primarily American. Only a few countries besides the United States forbid the devices within their borders. One is Canada, even though the Canadian Independent Advisory Committee review showed no causal link between silicone breast implants and serious illness. While most countries haven't even seriously considered removing silicone implants from use, some, such as the United Kingdom, have reviewed the evi dence and affirmatively stated that implants should remain available. In June 1994, the 20-member European Committee on Quality Assurance and Medical Devices in Plastic Surgery declared it "does not support any restriction on the use of silicone-gel filled implants."
Because of the ban in the United States, American women have gone to other countries, includ ing the United Kingdom, Mexico, France, and Germany, to get implants. One popular package mixing implantation in an English hospital with a trip to Shakespeare's birthplace is called "Boobs n' Bard." Having to go abroad for implants, of course, prices some women out of the market. Women who do travel for implants face different problems: If something goes wrong with the surgery, the doctor is thousands of miles away. And malpractice suits are difficult to pursue in much of the world and virtually impossible in South and Central America.
The FDA seriously considered pulling saline-filled implants off the market as well. But in late 1994, it decided to allow their continued use pending approval applications due in 1998. Silicone is generally preferred to saline because it gives the breast a more natural feel. To keep saline-filled breasts from swishing like a waterbed, it is necessary to pack them tight with the solution. In breasts that are quite small to begin with, wrinkles or ripples in the implant surface are more easily visible through the skin and the breast may not move or hang as naturally as it would with silicone implants.
Whatever goes into the implant of the future, the silicone implants of today are in the bodies of a million or more women who need to know what risk, if any, these devices pose.