Silicone Implant Controversy Puts Lawyers on Trial

By Michael Fumento


Copyright 1996 Michael Fumento

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Pity the lawyers who for so long have been circling the breast implant manufacturers and the one million women in this country with such implants. June was a very bad month for them.

For the past several years, lawyers have been reaping contingency fees by the tens of millions by alleging that sick women with breast implants must have gotten their diseases from the implants. In one case, a team of attorneys hit the jackpot with a $33 million award on behalf of three women. The $4.2 billion settlement the breast implant manufacturers agreed to in 1993 was the biggest settlement or award in legal history.

In the meantime, women with implants have been utterly terrified. Two even took razor blades to their bosoms and cut out their own implants. But the science behind the claims has always been weak and last month it just became a lot weaker.

The main health charge against implants is that they cause connective tissue disease, a broad category encompassing problems such as lupus and scleroderma which, not coincidentally, have always disproportionately plagued the persons most likely to get implants — young women. No studies, according to the British Department of Health in a 1995 overview, "demonstrated that the co-existence of connective tissue disease with silicone gel breast implants is any more prevalent than would be expected by chance."

The latest and largest of these appeared in the June 22 New England Journal of Medicine (NEJM), which looked for evidence of 41 types of connective-tissue disease among 87,501 nurses, of whom 1,183 had implants. It found that on the whole women with implants were slightly less likely to have symptoms of these diseases or to even complain of symptoms or signs of illness resembling these diseases.

An even more serious charge against implants is that they cause cancer. This was spread in great part by the Naderite group Public Citizen, which — by great and fantastic coincidence — makes money providing information and clients to trial lawyers who do implant litigation.

But the June 8 NEJM is the latest study to deflate that charge, as well. Looking at a group of almost 11,000 women it found those with implants had no higher rate of breast cancer than those without.

Yet a third blow came at the end of the month when the FDA evaluated a study of implants coated with polyurethane. Later investigation showed that some of the polyurethane broke down into a substance which causes cancer in rodents when injected into them at high doses. But as for people, the FDA has now concluded, "it is unlikely that exposure to [to the break-down substance] will cause cancer in even one of the women with these implants."

They don’t call ’em "sharks" for nothing.

But not just manufacturers are paying the price. This lawsuit against science is now triggering a wave of suits against medical implants made of various form of silicone and even some containing no silicone at all.

Some 7.5 million medical devices are implanted in Americans each year, including 1.5 million patients who receive silicone eye lenses and 670,000 who get artificial silicone joints. Many of these devices are life-saving, such as pacemakers, heart valves and shunts which draw fluid off the brain.

"I’m alarmed" at the litigation trends says Dr. J. Donald Hill, chairman of cardiovascular surgery at California Pacific Medical Center. Without these devices, he says, "patients could die."

Our only solace may be the number of trial lawyers among them.


Read Michael Fumento’s additional work on breast implants and on the FDA.