A new paper in Annals of Internal Medicine once again revisits the very long-running controversy of whether silicone breast implants actually caused harm to women who used them prior to 1992, when the FDA ordered them off the market. That controversy, which was all but settled years ago, has since returned.
My Science 2.0 piece entitled "Silicone On Trial: Bastardization Of Justice," is a review of a book by a physician who was right in the middle of the controversy. American Council trustee, Dr. Jack Fisher, a retired plastic surgeon and perhaps one of most formidable experts on the topic today, made it quite clear in his book, Silicone On Trial: Breast Implants and the Politics of Risk (Sager Group LLC, 2015) that the appalling affair resulted in nothing except unnecessarily frightening a large number of women, and making attorneys wealthier.
Apparently, despite a subsequent mountain of medical evidence that cleared the implants entirely, this matter is not yet "settled," evidenced by an article entitled "Long-Term Health Outcomes in Women with Silicone Gel Breast Implants: A Systematic Review," by Ethan M. Balk,
The purpose of the paper was "[t]o systematically review the literature regarding specific long-term health outcomes in women with silicone gel breast implants, including cancer; connective tissue, rheumatologic, and autoimmune diseases; neurologic diseases; reproductive issues, including lactation; offspring issues; and mental health issues (depression and suicide)."
The authors found nothing, which Dr. Fisher could have predicted in the first place.
"The evidence was most frequently not specific to silicone gel implants," he said, "and studies were rarely adequately adjusted for potential confounders."
Dr. Fisher continues by saying, "in their continuing search for an association between silicone gel breast implants and adverse health outcomes, the authors conclude that 'the evidence remains inconclusive,' as if the link exists but remains hidden. Doesn t this only serve to support the ill-derived precautionary principle, aka 'paralyzing principle?'
"It is far better to reassure the many millions with exposure to myriad silicone devices including breast implants that the most intensive study of this problem was conducted by the Institute of Medicine in 1998 and reported in 1999," he adds. "A panel of thirteen distinguished scientists reviewed the existing evidence and ¦ 'declared invalid any carcinogenic, mutagenic, teratologic, or immunologic influence."'
As Dr. Fisher noted in his book, The available toxicological evidence for silicone polymer safety in animals and in humans was substantial and convincing, even at challenge doses far greater than would be experienced by women with breast implants."
Fisher is incredulous that this is even being mentioned anymore, let alone being studied yet again. He also wonders why the implants have been singled out.
"Although the focus of activists critical of silicone has always been directed at breast implants, the fact remains that silicone polymers are ubiquitous in our environment and have been since their re-discovery during WWII," he says. "Health care today would not be the same without silicone, nor would the beverage and aerospace industries."