Silicone Implant Controversy Puts Lawyers on Trial

By Michael Fumento

Copyright 1996 Michael Fumento

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."

The lawyers never had science on their side, but they had something better. First was a wholly credulous media which ignored scientists and scientific data in favor of sensational and terrifying stories about implanted women as "ticking timebombs." These relied on anecdotes from women convinced their implants were making them sick. After all, they were healthy when they had the surgery but now, years later, they are ill. Yes, and they were also healthy before that black cat crossed their path, but we're too sophisticated to blame them anymore.

More than this, they had FDA Commissioner David Kessler. Although his own agency's panel twice recommended keeping implants available, he overrode them both times.

It may be Kessler was jockeying to keep from being fired during the Clinton transition, or perhaps he's just as regulation-happy as his foes claim. Whatever the explanation, his aid has proven priceless. Although even he has said the ban was never meant to implicate implants as harmful, merely as not proven safe, newspapers are filled with attorney solicitations citing the ban. "100,000.00 OR MORE MAY BE OWED TO YOU!" proclaimed one.

That's one reason the $4.2 billion settlement now appears to be too low by as much as another $70 billion. Yes, billion.

Now the lawyers have lined up 16 of their buddies in Congress to demand a congressional investigation of implant manufacturer Dow Corning. The ringleader, Democratic Rep. James Traficant of Ohio, even boasts of working with the trial lawyers. But sorry guys, it's been done. The Justice Department dropped its investigation in May for lack of evidence.

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. Michael Fumento is the author of numerous books, including a monograph entitled Silicone Breast Implants: Why Has Science Been Ignored?