Breast implant report welcomed, jeered
Monday, 21 June 1999 23:41 (GMT)
Breast implant report welcomed, jeered
UPI Science News
WASHINGTON, June 21 (UPI) - Advocates for women who believe they've
been harmed by breast implants say a newly released study that shows no
link between the devices and chronic illnesses like cancer and
rheumatoid arthritis is seriously flawed.
But plastic surgeons welcomed the report, saying it confirms the
safety of the implants.
Janice Ferriell, president of the National Breast Implant Task Force
in West Palm Beach, Fla., says the research, released Monday by the
Institute of Medicine, found no link because many of the studies
investigated by the panel were funded by breast implant manufacturers,
like Midland Michigan-based Dow Corning Corp.
Earlier this month, thousands of women who had sued the company
agreed to a $3.2 billion settlement plan. A federal judge will decide
whether to approve the plan next week.
Ferriell says, "This is not the last word. This is looking at the
studies already out there, paid for by the manufacturers."
She adds, "Almost every epidemiological study that's been done has
been paid for by the manufacturers."
Another problem with the research, she says, is that it looks for
known diseases, while silicone implants may be creating a new kind of
reaction that may not have been seen before.
She says, "This is a man-made disease."
Janet VanWinkle, founder of another group, the American Silicone
Implant Survivors in St. Louis, says, "I think it's a bunch of (public
Both women are waiting for the results of a $4.1 million government-
funded study of the long-term effects of breast implants currently
underway at the National Cancer Institute. The NCI study is expected to
be completed later this year.
NCI scientists will examine medical records of 13,500 women who had
breast implants before 1988, and comparing their rates of cancer and
connective tissue diseases to women who did not have implants.
In the newly released report, a panel of 13 experts found that women
who have these implants face no greater than average risk of cancer,
neurologic disorders or diseases of the immune system, such as
rheumatoid arthritis or lupus.
The scientists did find, however, that implants are likely to
rupture, cause infections or require repeated surgeries.
Committee chairman Stuart Bondurant, professor of medicine at the
University of North Carolina, Chapel Hill, says that while the study
does not show an increased risk of life-threatening illness from breast
implants, it is clear that they can cause serious problems.
Attorney Jamie Sheller, of the Philadelphia law firm of Sheller,
Ludwig & Badey, says, "The fact that studies paid for by the
manufacturers found no connection is no surprise." She says earlier
studies looking at the risk of disease in women with these implants had
flawed designs, and later ones were funded by the manufacturers.
But Sheller, who is representing 700 women who say their breast
implants have caused health problems, says the new study does support
that they are not complication-free.
"It tells us a lot about what we already do know," she says.
Most of her cases, she says, are based on local injury, the easy-to-
see damage from the implant itself, like ruptures and contractions of
the tissue surrounding the silicone bag. This, she says, leads women
into a nightmare of repeated trips to the operating room.
Sheller says, "I call it the surgery treadmill."
Some of her clients have told of finding lumps of silicone that have
migrated from the breast to the arm, where they at first appear to be
cancerous tumors. It's a terrifying experience, says Sheller.
Although her firm has settled many of the cases with manufacturers,
cases brought against plastic surgeons are expected to go to trial early
next year. The women say the doctors did not tell them about the
potential health problems, particularly that these devices wear out -
many in as short a period as a decade.
Sheller says, "They were told they would last a lifetime."
Epidemiologist Virginia Ernster, vice chair of the committee, says
that the panel examined peer-reviewed data, some funded by
manufacturers, some not. But she says the report looks at the totality
of good evidence, and that the report's findings - that silicone breast
implants are not the cause of life-threatening illnesses - are
consistent with other earlier reports from the United States, Europe and
Australia. Ernster is a professor of epidemiology and biostatistics at
the University of California, San Francisco School of Medicine.
But, she says, "By the same token, one should emphasize we found in
the literature a high frequency of local complications."
Like Sheller, she says she has heard from many women who say their
doctors did not give them sufficient warning about the risks of the
She says, "That's what concerns us."
Women who have these implants should be monitored closely, so that
scientists can get an accurate picture of how often they cause problems.
She also says that since the early 1990s, many new kinds of implants,
such as those based on saline, have replaced the silicone models, and
nothing is known about the effects these may be having on health.
But in a press conference at a meeting of the American Medical
Association today in Chicago, plastic surgeons welcomed the report,
saying it confirms the safety of the implants.
But Dr. Paul Schnur, president of the American Society of Plastic and
Reconstructive Surgeons, said, "This report is wonderful news for women
with breast implants. These are the strongest findings to date
confirming that silicone breast implants are safe for women."
Despite being swamped by litigation over purported silicone disease -
litigation that forced implant manufacturer Dow Corning into bankruptcy
- Schnur predicted that if the Food and Drug Administration clears the
implants for use, other manufacturers will put the implants on the
Dr. Norman Rappaport, clinical assistant professor of surgery at
Baylor College of Medicine, Houston, said, "The report will put women
at ease." Rappaport is president of the American Society of Aesthetic
Plastic Surgeons that he represents in the AMA House of Delegates.
The IOM, a private non-profit government funded arm of the National
Academy of Sciences, says between 1.5 million and 1.8 million women have
had breast implants in the United States.
(Written by Mara Bovsun in New York City; Ed Susman in Chicago
contributed to this report)