The future of breast implant
litigation is beginning to look like a bust to the nation's trial
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 9,0002 implant cases reached this conclusion:
available scientific evidence does not link breast implants with
Furthermore, a congressionally-ordered
study conducted by the Institute of Medicine also reported this
summer that implants cannot be shown to cause connective tissue
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% 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
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
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.
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, page 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. Doug Bandow, "Torts
Later, The Case Against Implants Collapses," Wall Street
Journal, November 30, 1998.
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. Comments may be sent to [email protected]