US FDA Allows the Continued Use of Textured-Surface Breast Implants and Tissue Expanders From Allergan, Mentor, and Sientra

Thursday, May 2, 2019

https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas

Commissioner Amy Abernethy, MD, PhD, and Director of the FDA’s Center for Devices and Radiological Health (FDA CDRH), Jeff Shuren, MD, JD, issued a statement on Thursday, May 2nd with regards to the March 2019 public advisory hearing on breast implants. The FDA CDRH has undertaken several steps to better understand this issue, including an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant-specific registries, as well as public discussions on a wide range of important topics related to breast implant safety, such as the use of surgical mesh in breast implant surgery, characterization of BIA-ALCL incidence and risk factors, and methods for assessing systemic symptoms of what has been referred to as “breast implant illness” (BII).

During the two-day public hearing in late March, there were comments and personal anecdotes from a broad range of public, scientific, medical and other stakeholders. ISAPS was represented by Nina Naidu, MD, the ISAPS National Secretary for the United States.

Following the advisory hearing, the FDA stated that regulatory action must be based on scientific data. Based on all the data and information available currently, the FDA does not believe that there is enough evidence to meet the banning standard set forth in the Federal Food, Drug and Cosmetic Act.

In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S. The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold in the United States. Polyurethane-coated implants are not available in the US.

While the majority of women who developed BIA-ALCL had textured implants, the FDA states that there are known cases in women with smooth-surface breast implants as well. Additionally, many reports do not include the surface texture of the implant at the time of diagnosis. The FDA concluded that women and providers must be adequately informed of the risk of BIA-ALCL, and made aware that the risk is higher with the use of textured implants, albeit still low.

The FDA looked favorably at partnering with registries, like the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE), which collects real world data on patients with BIA-ALCL diagnoses, and the new National Breast Implant Registry (NBIR), which collects data on the safety and performance of breast implants.

I would like to thank the ISAPS Members who submitted comments to the FDA CDRH with regards to textured breast implants, BIA-ALCL, and BII. Thank you for your assistance in this important matter as it relates to the availability of textured-surface breast implants and tissue expanders for patients.

This decision by the US FDA CDRH will be viewed by medical device regulatory agencies worldwide and is consistent with the position of ISAPS that a ban of textured and polyurethane-coated implants is an improper decision in terms of overall patient safety, when based on the currently available data.