The investigators determined that capsular contracture was the most common reason for reoperation among patients undergoing breast augmentation, and that short-term reoperation was higher among patients who either received silicone implants or who had surgery for primary reconstruction — and the most-observed reason for short-term reoperation across both manufacturers was related to the way the implants looked cosmetically, according to the authors.
In addition, attrition in follow-up occurred as time passed across both manufacturers, and compliance with surveillance imaging after surgery was determined to be poor: 5.2% for 3-year baseline and less than 5% at least 5 years following implant surgery. FDA currently recommends MRI surveillance of silicone implants at 3 years after surgery and every 2 years thereafter.
The study authors alleged the postmarketing data that log harms from implants “have never before been reported” and stressed that the patient-level data should “be made available for unbiased analysis of these harms.” The study authors added, “Despite abundant data collection, and open public access, the LPAS database has yet to be fully analyzed and reported … The existing literature is sponsored by industry, and focused on a single manufacturer by design.”1
That single manufacturer referenced is Allergan — and the authors wrote that the company’s data on postapproval safety are limited and provided fewer diagnoses compared with those that appeared in the FDA database. And, although the authors suggest the FDA data show an association between silicone-based implants and connective tissue disease (CTD) or rheumatologic disease, the separate, non-publically-available summarization of the LPAS data by the manufacturer itself “reported no significantly higher rate of CTD, or any systemic harm investigated in our study at 5 years.” The authors explained that in contrast to the postapproval claims found in the publicly available FDA database, the data from Allergan only included reports of patient harms that were confirmed by a physician. As a result, the authors said Allergan’s overview was a conservative take on what the true harms may be.
Allergan did not respond to requests for comment at press time, nor did it post a press release discussing the results of the study.
On September 14, 2018, FDA issued an official agency statement in response to the study’s findings, and raised flags about the reported connection between breast implants and connective tissue diseases/reproductive problems. “We commend the work of our peers in studying the risks of breast implants. However, we respectfully disagree with the authors’ conclusions.” Citing methodology issues and possible author bias, the FDA urged the public to view the findings “with caution.”2
In an FDA editorial published alongside the study by Dr Coroneos and colleagues, Binita Ashar, MD, MBA, FACS, general surgeon and director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, re-upped the stance that there is no evidence of a connection between breast implants and CTD or arthritic conditions. She backed this claim up via a citation of a study, first published in 2015, that supported these conclusions — a study which was commissioned and supported by the Plastic Surgery Foundation through financial contributions provided by Allergan, Mentor, and Sientra, another implant manufacturer.3