Silicone Gel Breast Implant Litigation
"Silicone Scare"
Channel 2 News
Chicago, Illinois
February 2, 1996
10:00 P.M.
26:08 - 30:41
Linda McClellan: In medicine, tonight in 1992, the FDA banned silicone gel breast implants for all but a limited number of women, not because of known risks but because of possible risks. Now four years later many are asking was it real or was it a silicone scare. Mary Ann Childers is here now with more, Mary Ann.
Mary Ann: Linda there are risks, all implants eventually get hard, they can rupture, cause pain and make mammography more difficult, but do they cause serious immune related diseases such as arthritis, lupus or worse. Thousands of women say they've poisoned their bodies. While there is no question in the minds of women who are suffering, the FDA says that risk remains unproven.
For some people this is the ideal body image, some are born with it, others turn to implants, but not this type, this is silicone. Since 1992 new patients can only get implants that are saline filled. Still, augmentations remain popular, in fact the number of women who choose this surgery is growing and questions about the moratorium on silicone remain.
Dr. 1: I look at it as the hoax of the century.
Mary Ann: Now new research is also heating up the debate. Recent studies say there's no link between silicone gel implants and disease. Studies at the Mayo Clinic and Harvard published in the prestigious New England Journal. The American College of Rheumotology agrees, some believe its time to take a second look.
Sharon Green: I don't doubt that these people are sick, the question is are they sick because of the implants.
Mary Ann: The FDA says "we don't know" saying only in its most recent update that these newly reported studies provide some reassurance about the long term safety of silicone gel-filled breast implants. But Ruth Brody, a seven year breast cancer survivor has already made her decision. She wanted gel implants from the start.
Ruth Brody: When I found out prior to surgery, that I had an option that I could wake up a whole person, it made all the difference in the world to me and enabled me to deal with the disease and get on with what I had to do.
Mary Ann: Right now the only women who can get gel implants are cancer patients who need reconstruction, women who suffer traumatic injuries or those who need to have gel implants replaced. You can't get them for breast enlargement. But even if you qualify, you must be part of a clinical trial and find a surgeon who will use them, many today refuse. You also have to get in line. Right now there is a major shortage of silicone gel implants. Ruth Brody worries they won't be available if she needs hers replaced.
R. Brody: They've taken my right away, they've taken my choice away.
Mary Ann: But Carla Hobbs-James would like to see implants off the market for good. She got her's after breast cancer surgery in 1991.
Carla Hobb-James: The worst mistake of my life... the worst.
Mary Ann: Within weeks she began suffering chronic fatigue and crippling joint pain, ten months later the implants were removed, but the pain is still there.
C. Hobbs-James: I don't think that I would of had, to this extent, arthritis the way that I have it. At my age, I'm too young to have it like a seventy or eighty-year-old woman.
Mary Ann: Attorney Ken Moll represents more than five hundred women who claimed to have been injured by implants. He says the Harvard and Mayo Clinic studies are seriously flawed and biased.
Kenneth B. Moll: The classic example of how you can manipulate the science to conform it to what they want it to say.
Mary Ann: Moll's concerned that the research and some of the researchers themselves were funded by breast implant makers, that the studies didn't follow enough women for long enough and that they focused on the wrong thing. Familiar diseases like lupus and arthritis, while silicone problems and symptoms often look very different.
Gail Lebovic, M.D.: (Implant researcher) It's possible that silicone may cause an immune response that isn't related to classical symptoms or things that we've measured before. So maybe we're looking at something new.
Mary Ann: Doctor Lebovic whose been researching a soybean oil filled implant, says with so many women so sick more research is critical.
And that may be the only thing that pepole on both sides of this issue agree on, so was it real or was it a silicone scare? Well the frustrating thing is that four years later there are no definitive answers. Even the FDA says it's going to take decades of research and many of the important studies haven't even begun. And Linda, in the spirit of full disclosure, I'm on the honorary board of "Y- Me?" which is an organization that supports and helps women with breast cancer.
L. McClellan: Thanks Mary Ann.