Diana Zuckerman, Ph.D.
President, National Center for Research for Women & Families
Edward A. Luce, MD, FACS
President, American Society of Plastic Surgeons
It’s time to get past the hype about implants. Manufacturers’ own studies report that most breast-cancer reconstruction patients and 40% of augmentation patients have local complications within three years, including serious infections, severe pain, leaking implants, and the need for additional surgery. The long-term safety of breast implants is not yet known. The Institute of Medicine reviewed implant studies conducted before 1999, and found little evidence of systemic diseases. But those studies-conducted using Dow grants at Mayo Clinic and elsewhere-usually scrutinized a few diseases among just a few hundred women with implants, many of whom had implants for only a few months or years. Imagine if our only studies of smoking were based on people who smoked for an average of 7-10 years! New research by the NCI, the FDA, and several medical schools raises new concerns. MRIs indicate that most women with implants for 11-15 years had at least one rupture, and if the silicone migrated away from the breast, women were significantly more likely to have several painful and potentially fatal diseases. Two NCI studies found that women with silicone or saline implants were at increased risk of dying from brain cancer, lung cancer, or other respiratory disease. These women had a 21% increased risk of cancer, compared to women in the general population. These NCI studies were published after the IOM report so they were not included. Last year, more than 200,000 teenagers and women underwent breast augmentation surgery, and over 65,000 breast cancer patients chose implants over other alternatives. These women should be told that the complication rate is high and the long-term health risks of implants are still being studied.
The scientific literature to date finds no evidence to link breast implants to connective tissue disease, cancer, or health risks. Numerous epidemiological studies have been performed, including a 30-year retrospective at the Mayo Clinic, a 14-year study by Harvard, a study in JAMA of nearly 400,000 women, and a U.K. Minister of Health report. In May 2000, the IOM concluded, “Evidence clearly shows that silicone breast implants do not cause breast cancer.” It also reported: “There is no evidence that silicone breast implants contribute to an increase in autoimmune diseases.” Critics of breast implants have cited three recent studies linking implants to increased health risks. But these studies have been soundly criticized for presenting a selective and incomplete review of literature, as well as publishing conclusions that were statistically insignificant, and according to one scientist on the NCI panel, most likely due to chance. Local complications, including the rupture, deflation, and deplacement of implants, contracture of tissue, and infection are possible when women elect to have breast augmentation or reconstruction following a mastectomy. Women today who consult with a plastic surgeon certified by the American Board of Plastic Surgery are more informed and better apprised of the benefits and risks of breast-implant surgery than ever before. The American Society of Plastic Surgeons strongly believes that additional research should be conducted. To that end, the society has created a voluntary registry to collect data on the long- and short-term effects of breast implants. Also, the ASPS supports the FDA in its efforts to ensure patients receive safe and effective medical devices. That’s because patient safety is the bottom line for all ASPS members.