A study linking silicone gel-filled breast implants with several rare diseases should be viewed with caution, according to FDA.
The authors of the study, published last week in the Annals of Surgery, say they looked at data from nearly 100,000 breast implant procedures gleaned from FDA-mandated postmarket studies for implants made by Johnson & Johnson's Mentor business, and by Allergan. The analysis showed that silicone implants are associated with higher rates of Sjögren syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma.
The researchers reported that 56% of the implants included in the database were silicone for primary augmentation. They also found that, in the short term, rupture rate is higher for saline-filled implants compared to silicone gel-filled implants (2.5% vs. 0.5%), but capsular contracture, a condition that develops when internal scar tissue forms a tight or constricting capsule around the implant, contracting it until it becomes misshapen and hard, was higher for silicone (5.0% vs. 2.8%). At 7 years, the reoperation rate is 11.7% for primary augmentation and 25% for primary/revision reconstruction. Capsular contracture occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations.
"Silicone implants are associated with an increased risk of certain rare harms," the authors concluded. "Associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants."
FDA published an editorial response alongside the study, pointing to "significant shortcomings" with the study's methodology, how the data is presented, and its conclusions. The agency noted inconsistencies in the data and potential sources of bias.
Breast implants have been a source of contention between patient advocacy groups, industry, and FDA for decades. Implants were banned from the U.S. market from 1992 to 2006, and the devices have been the cause of an overwhelming number of lawsuits. Last year, a California woman sued Johnson & Johnson and two of its subsidiaries, claiming that leaking silicone breast implants caused muscle pain and nausea.
When FDA lifted the 14-year moratorium on silicone breast implants in 2006, each manufacturer (J&J's Mentor, and Allergan) was required to conduct six post-approval studies to further characterize the safety and effectiveness of their breast implants and to answer additional scientific questions about the long-term safety of breast implants that the premarket clinical trials were not designed to answer.
As part of these post-approval studies, FDA collected data from the studies totaling nearly 100,000 patients. FDA previously reported the results of these studies, which were the same studied that formed the basis for the recently published assessment. In 2011 the agency identified a possible link between breast implants (both silicone and saline-filled) and anaplastic large cell lymphoma.
"We understand that there are concerned patients with breast implants who are experiencing a range of symptoms that may or may not be related to their breast implants," said Binita Ashar, MD, a general surgeon and the director of the Division of Surgical Devices in FDA’s Center for Devices and Radiological Health. "We take these concerns seriously and are committed to continuing to work with patient groups, surgeons, and scientists to further assess this issue. While the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases, we respect studies like the ones published in Annals of Surgery by our peers. These studies contribute to our discourse on this topic, but more evaluation is required."
In the editorial, Ashar said the authors of the current study failed to account for methodologic differences between studies, inconsistencies in the data, differential loss to follow-up, as well as confounding and other potential sources of bias. That's why FDA says the study's conclusions should be viewed with caution. She also noted that the limitations of the report highlight the need for better postmarket evidence generation, including active surveillance capabilities.
Ashar said the agency is working with multiple stakeholders to develop a National Breast Implant Registry (NBIR) to provide a platform for evaluating real-world data on the safety and performance of breast implants.
"We have heard from patients who are concerned that their implants may be connected to other health conditions, like chronic fatigue, cognitive issues, and muscle pain," Ahsar said. "While the FDA does not have evidence suggesting breast implants are associated with these conditions, information from NBIR may help us identify risk factors for complications, such as a patient’s own medical history, the specific type of operation, the type of implant used, and concomitant use of other medical devices. Greater information-gathering from a registry like NBIR will add helpful information to the FDA’s already extensive review of our own medical device reports, review of medical literature, assessment of post-approval studies, and meetings with patients."