Likewise, a separate effort that launched in September 2018 in collaboration with multiple stakeholders is the National Breast Implant Registry (NBIR). This registry provides a platform for evaluating real-world data on the safety and performance of breast implants that will greatly contribute to helping us evaluate data from providers regarding their patients with implants. We’ve heard from patients who are concerned that their implants may be linked to other health conditions, like chronic fatigue, cognitive issues and muscle pain.

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 regarding breast implant safety.


The FDA is also continuing to monitor and communicate about known risks associated with breast implants, such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In addition, we’ll hold an advisory committee meeting in 2019 to ensure that patients and health care providers continue to have accurate, scientifically sound information about breast implant safety and effectiveness, and to promote public dialogue on the issue.

--“Vaginal Rejuvenation” Devices

We’re also continuing to monitor a specific set of energy-based devices in which certain manufacturers may be inappropriately marketing their devices to women. This past summer, we warned women and health care providers about a growing number of manufacturers marketing “vaginal rejuvenation” devices to treat conditions and symptoms related to menopause, urinary incontinence or sexual function – even though the FDA has not received evidence that these devices are safe or effective to use for these indications. We’re announcing today that after reaching out to the seven manufacturers marketing their devices for unapproved or uncleared uses, all of them have made significant changes to their websites to remove claims associated with vaginal rejuvenation and other unapproved treatments. Our efforts to address these safety concerns is part of our broader work to improve our analysis of data and generation of RWE concerning the safety and effectiveness of health technologies in clinical areas that are unique to women.

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