Researchers at The University of Texas MD Anderson Cancer Center conducted the largest study of long-term safety outcomes for people with breast implants. This study shows that silicone implants are linked with several rare diseases, autoimmune disorders, and other health conditions. However, the study did not establish a causative relationship between these health conditions and the implants. The results of the MD Anderson study are consistent with other studies that investigated the safety of silicone breast implants.
Published in 2018 in the Annals of Surgery, the study looked at the outcomes of nearly 100,000 patients with both silicone and saline implants. The data goes all the way back to 2006, which is when the FDA lifted its moratorium on silicone breast implants. The FDA required breast implant manufacturers to conduct post-approval studies to examine the potential link between the implants and rare systemic diseases.
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, one specific brand of silicone implants had a 2 to 8 times higher incidence of Sjogren syndrome, scleroderma, melanoma, and rheumatoid arthritis in contrast to the general population. This occurred with one group in the report. The other group of patients had a different brand of silicone implants that were used for reconstruction. This group experienced 2 times the incidence of Sjogren syndrome, scleroderma, and dermatomyositis in contrast to the general public. One case of breast implant associated with 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 researchers also examined the patients’ satisfaction, well-being, and reproductive health. They found no links between breast implants and fibromyalgia or suicide. Reproductive outcomes were inconsistent. They found a higher patient-reported rate of neonatal intensive care, preterm birth, and stillbirth, but no link to miscarriage.
There was a lower patient-reported rate of congenital malformation or birth defects among women with silicone implants. “These two areas merit additional research to fully understand the underlying issues”, said Clemens.
The research team at MD Anderson consults frequently with patients who are looking into breast implants for reconstructive breast surgery or augmentation.
Patients are seeking 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.
According to the American Society of Plastic Surgeons, nearly 400,000 implants are used in the United States annually for reconstruction surgery and augmentation.