FDA Panel Recommends New Postmarket Requirements for Breast Implants

Regulatory NewsRegulatory News | 26 March 2019 |  By 

As part of efforts to make breast implants safer, the US Food and Drug Administration (FDA) should consider additional postmarket data reporting requirements on breast implant manufacturers, the agency’s General and Plastic Surgery Devices Panel suggested after a two-day meeting.

On whether to remove textured breast implants from the US market as other countries have done, the panel argued data is lacking to support such a recommendation as it would reduce options for patients.

Panel members heard from regulatory authorities, such as Health Canada, and members of the European taskforce on breast implants, patients and patient organizations, to inform FDA’s future regulation of breast implants. The panel questions were mainly directed at addressing concerns on an increasing number of adverse events, particularly breast implant associated anaplastic large cell lymphoma (BIA-ALCL), linked to the use of breast implants.

The panel deliberations underscored a growing awareness of a lack of information in medical device reports (MDRs) crucial to monitoring adverse events in postmarket settings.

A finding FDA shared in the report the agency prepared ahead of the meeting that struck panel members and others revealed a significantly larger number of MDRs associated with BIA-ALCL cases. The graphic below shows that FDA received hundreds of thousand of MDRs between 2010 and 2018, despite the last update on FDA’s MDR review having reported just 660 MDRs in total over the same time period.

FDA officials continued to cite 660 MDRs during the meeting, while others attributed the major dip in publicly available adverse event reports to the agency’s contentious voluntary reporting program.

The agency’s report noted several challenges in the current MDR landscape. “In most of these reports, the full patient history of prior implants, including the implant surface type and the tissue expander surface type, is unknown,” FDA said. Data on the number of received breast implants is also unavailable.

In addition to including the device specifics in MDRs, such as whether the breast implant is textured or smooth, panel members also supported the inclusion of outcomes regarding implants’ total lifecycles.

FDA recently touted two breast implant registries it intends to better leverage as part of its surveillance efforts. Yet at least most panel members argued a consolidated registry that can be used globally would be better. 


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