Breast implants remain at the top of the list of tools used by plastic surgeons to augment breast size or to reconstruct the breast following mastectomy. More than 10 million women worldwide have breast implants. According to the American Society of Plastic Surgeons annual procedural statistics report, there were more than 300,000 breast augmentation procedures and more than 100,000 breast reconstruction procedures performed in the United States in 2017. Among breast reconstruction procedures, implant-based techniques accounted for 82% of all reconstructions in 2017.

In recent years, Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) has received plenty of attention among plastic surgeons as well as the public. This disease remains a rare sequelae of breast augmentation and breast reconstruction in the setting of saline or silicone gel implants. We have gained substantial knowledge regarding its epidemiology and treatment, but controversies about etiology and pathophysiology remain. The topic has been succinctly reviewed by well-respected plastic surgeon and IMCAS contributor Dr. Maurice Nahabedian in a recent blog .

Perhaps due to increased awareness about BIA-ALCL, more patients are presenting to plastic surgeons to discuss elective implant removal in the United States. Some of these patients complain of qualitative symptoms that include memory loss, joint pains, muscle aches, and chronic fatigue. In 1992, the FDA issued a moratorium on the use of silicone gel breast implants because of concerns that they may be linked to cancer, connective tissue disorders, and autoimmune diseases. Extensive research (review of 1078 peer-reviewed articles) led the National Academy of Science Institute of Medicine to conclude that there was no evidence to support an association between silicone breast implants and systemic disease. In 2006, the FDA approved the current generation of silicone gel devices for Mentor and Allergan in the United States.

Researchers from the MD Anderson Cancer Center recently published a review of long-term FDA post-approval data from the two largest implant manufacturers Mentor and Allergan. Data from nearly 100,000 patients provided some additional insight into systemic complaints associated with silicone and saline implants. Compared with “normative” data, patients with silicone breast implants were found to have higher rates of autoimmune disorders (Sjogren’s syndrome, scleroderma, rheumatoid arthritis), stillbirth, and melanoma. There was only one case of BIA-ALCL reported in this study. While these results appear to be alarming, this study suffers from limitations because patients could not be evaluated at an individual level. Even the FDA disagreed with the study’s conclusions based on shortcomings with study methodology, inconsistencies in data, and potential sources of bias. This study could not control for confounding factors that may have contributed to healthcare outcomes. Although the original post-approval studies enrolled 99,993 patients, subset analysis only included silicone implants followed for 2 or 7 years (less than 34,000 patients). Critics have also called into question the validity of “normative” population rates of these relatively rare diseases.

The FDA continues to collect and analyze post-market surveillance of adverse events, which have spiked since 2017 in response to enforcement of its reporting rules. Reports now suggest that many flaws exist in how device safety is tracked. The FDA maintains that there is no apparent association between silicone gel breast implants and connective tissue disease, breast cancer, or reproductive problems. The data are based on studies that were under-powered to detect rare conditions with follow-up that was not long enough for problems to develop. In collaboration with the FDA and all breast implant device manufacturers, the Plastic Surgery Foundation has invited all U.S. plastic surgeons to participate in a prospective outcomes and safety surveillance registry known as the National Breast Implant Registry. Unfortunately, participation is voluntary, and patients/physicians can choose to withdraw from future registry data collection at any time, both of which severely limit the impact of this initiative.

When we evaluate and counsel patients who are seeking breast augmentation or breast reconstruction, all of these issues must be addressed during the shared-decision making process. We must remember that the vast majority of women with breast implants maintain high satisfaction and lead healthy lives. However, the uncertainty of developing a rare complication should be carefully weighed. Plastic surgeons should continue to look for the most accurate, evidence-based information on silicone implant outcomes, although the challenges with data collection and transparency may never be solved. For reconstructive surgeons, an excellent alternative to implant-based reconstruction is autologous breast reconstruction, but not every woman may be a suitable candidate. No procedure is risk free, and all surgeons have encountered unusual reactions to breast implants. Breast implants will continue to face public scrutiny, and plastic surgeons must balance the explosion of biased information from the device industry, social media, patient advocates, and our own duty to protect patients from harm.