The future of breast implant litigation may be a bust for trial lawyers

By Amy Ridenour
web posted September 6, 1999

The future of breast implant litigation is beginning to look like a bust to the nation's trial lawyers.

Study after study has shown no link between breast implants and disease.1

Trial lawyers hoping to profit from future implant case awards and settlements took a major hit recently when a panel of four expert, neutral scientists appointed by the federal judge handling 9,000 2 implant cases reached this conclusion: available scientific evidence does not link breast implants with immune disorders.3

Furthermore, a congressionally-ordered study conducted by the Institute of Medicine also reported this summer that implants cannot be shown to cause connective tissue diseases.4

The case against the case against implants is not limited to the United States. In 1998, the European Committee on Quality Assurance and Medical Devices in Plastic Surgery found "conclusive" evidence that auto-immune and connective tissue diseases, like rheumatoid arthritis and lupus, are not caused by implants. The British government's Independent Review Group reached the same conclusion.5

All this is good news indeed for the one percent of American women with implants, approximately 20 per cent of whom got them for reconstructive purposes.6

But what is good news for patients isn't good news for trial lawyers spoiled by the $7.2 billion implant manufacturers have made available for settlements.7 With money pouring in at that rate, these lawyers are unwilling to see the spigot turned off.

These lawyers and their allies aren't happy that scientific studies are easing women's worries. They want studies that show implants are harming women: so much so, they're getting involved in the medical studies themselves.

But "scientific" studies involving parties with a financial stake in the outcome are rarely reliable
sources.

One FDA study that is raising more than a few eyebrows is expected to be published soon in the British medical journal Lancet. This study of implant rupture rates includes in a leading role a radiologist who has been paid by plaintiffs lawyers to testify in breast implant cases. The researcher not only analyzed the rupture rates for the study, but trained the technician who performed MRI scans for diagnosing ruptures.8

This is significant because a rupture finding through an MRI is highly subjective. What appears to one researcher to be a rupture may not to another. To increase accuracy, ultrasound and mammography can be used to verify the MRI findings, but that was not done in this study. The best way to diagnose a rupture is removal and examination of the implant. This method was not used in this study either.

According to the study protocol, it also diagnoses "rupture" in cases where no actual rupture or defect is found. The study cites as a "rupture" any case in which silicone is found outside an implant. This leads to an artificially high rupture rate, since silicone from earlier implants, from injections and
from other procedures may be present.

Even if rupture is the correct diagnosis, the study does not determine if the cause is manufacturer error. Implants can rupture for many reasons, including trauma and surgical error. There is even a medical procedure, called a closed capsulotomy, in which trauma is intentionally inflicted to loosen normal scar tissue surrounding the implant. This procedure, which is not recommended by implant manufacturers, can cause rupture.

Another warning sign is that the study examines a nonrepresentative sample of women. The study drew participants from a larger study of 17,424 women found through 19 plastic surgery practices, but only took women from two of those practices, both located in Birmingham, Alabama. Birmingham is the unofficial capital of breast implant litigation. Respondents there are more likely than most to have a history of implant complaints. Furthermore, of the 3,593 women invited to participate in the study, only 359 agreed to do so. It is not unlikely that women with implant problems were more interested in participation than women with no complaints.

This is somewhat akin to studying the nation's fondness for the Pittsburgh Steelers by interviewing only Pittsburghers with an interest in football. The study's results simply won't be representative of the nation as a whole.

Given the Clinton Administration's propensity to grant favors to its political donors, and the fact that
trial lawyers are top Clinton donors, the FDA should explain its involvement in a study of questionable objectivity. Trial lawyers are pinning their hopes that this study will do for them what so many others have failed to do: find that breast implants are causing unexpected health dangers for women. The continued profitability of breast implant lawsuits requires no less.

Footnotes:

1 See Amy Ridenour, "Alar Redux: Hollywood Peddles Shaky Science Once Again," National Policy Analysis #202, The National Center for Public Policy Research, Washington, D.C., June 1999, http://www.nationalcenter.org/NPA202.html: Doug Bandow, "Torts Later, The Case Against Implants Collapses," Wall Street Journal, November 30, 1998; among others.
2 "Burst Ballon: There's No Proof Breast Implants Cause Serious Ills," Time, December 14, 1998, p. 75.
3 Marcia Angell, "Trial by Science," New York Times, December 9, 1998.
4 Gina Kolata, "Panel Confirms No Major Illness Tied to Implants," New York Times, June 21, 1999.
5 Bandow.
6 "FDA Studies Breast Implant Complaints," UPI Science News, UPI, November 9, 1998.
7 Jocelyn Kaiser, "Panel Discounts Implant Disease Risk," Science, American Association for the Advancement of Science, June 25, 1999.
8 Eric Peters, "Junk Science Jeremiad," Washington Times, August 6, 1999.

Amy Ridenour is President of The National Center for Public Policy Research, a Washington, D.C. think tank. Comments may be sent to ARidenour@nationalcenter.org.




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