Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases.
MD Anderson study results consistent with previous studies.
In the largest study of long-term safety outcomes for patients with breast implants, researchers at The University of Texas MD Anderson Cancer Center have found that silicone implants are associated with some rare diseases, autoimmune disorders and other conditions; although a causative relationship has not been established. Results of the MD Anderson study are consistent with previously published studies that examined the safety of breast implants.
The study, published today in the Annals of Surgery, is authored by researchers in MD Anderson's Department of Plastic Surgery and reflects the outcomes of almost 100,000 patients with both saline and silicone implants. The information was derived from the United States Food and Drug Administration's (FDA) database dating back to 2005, when the United States moratorium on silicone breast implants was lifted. The FDA mandated that breast implant manufacturers perform post-approval studies, primarily to evaluate the potential association of breast implants with rare systemic diseases.
Mark W. Clemens, M.D.
According to Mark W. Clemens, M.D., associate professor, Plastic Surgery and senior investigator, the team looked at "certain rare diseases" and found an association with some autoimmune diseases and cancers, including scleroderma and melanoma. "This study did not report a direct link or causative effect between implants and these diseases. It is important to understand a limitation of the study was that some diseases were reported by patients and not necessarily diagnosed by a physician," said Clemens.
"This is important safety information for women to consider when thinking about cosmetic or reconstructive surgery with breast implants. It also underscores the need for more research in this area," said Clemens.
According to the study, which reflected data from two implant manufacturers, one group of patients with one brand of silicone implants reported a two to eight-times higher frequency of Sjogren syndrome, rheumatoid arthritis, scleroderma and melanoma compared to the general population. The other group of patients with another brand of silicone implants used for reconstruction reported scleroderma, Sjogren syndrome and dermatomyositis more than twice as often as the general public. One case of breast implant associated anaplastic large cell lymphoma was reported.
"It's vital that women with implants be aware of the potential risks, so they can identify symptoms early and consult with their doctors," said Clemens. "Fortunately, many of the diseases and conditions that have an association with implants are quite rare, so awareness is that much more important."
The research team also looked at patients' well-being, satisfaction and reproductive health. The study found no correlation between breast implants and suicide or fibromyalgia. The study reported that reproductive outcomes were inconsistent. In the MD Anderson study, there was a higher patient reported rate of stillbirth, preterm birth and neonatal intensive care, but no association with miscarriage. Compared to the general public, there was a lower patient reported rate of birth defects or congenital malformation among women with silicone implants. "These two areas merit additional research to fully understand the underlying issues", said Clemens.
Clemens and his colleagues consult with MD Anderson patients daily on the many options available today for augmentation and reconstructive breast surgery. "Patients frequently ask about the safety of implants," he said.
"Patients are seeking an assurance of safety. The FDA has deemed breast implants reasonably safe and effective, and being educated about potential complications is an important part of good health," said Clemens. "All surgical procedures and implantable devices have potential complications and side effects. As plastic surgeons, it's our responsibility to continually monitor the long-term safety of breast implants and make sure that all patients and physicians are aware of any possible adverse outcomes. This ensures that patients and their healthcare providers can weigh the potential risks and benefits together to make the best possible decisions on augmentation and reconstruction."
Breast implants are used in nearly 100,000 reconstructions for breast cancer and 300,000 augmentations annually in the United States, according to the American Society of Plastic Surgeons.
Co-authors on the study with Clemens include Christopher J. Coroneos, M.D., MSc.; Jesse C. Selber, M.D., MPH; Anaeze C. Offidile II, M.D., MPH; and Charles E. Butler, M.D., all of MD Anderson.