FORCE Weighs in on Breast Implant Safety and Informed Consent
December 23, 2019 - Today, FORCE submitted comments on U.S. Food and Drug Administration's proposed labeling and patient communication guidelines for breast implants. These updates follow a device safety hearing and recall of certain textured breast implants earlier this year. If enacted, the guidance will revise those established in 2006 by adding a boxed warning, patient decision checklist, revised rupture screening recommendations, and more.
The proposed changes follow July 2019 action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall certain models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.
Per the agency's request, Allergan recalled its BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
- If You Have Allergan BIOCELL Breast Implants
- FDA Safety Communication
- FDA Breast Implant website
- FDA Press Release
- Sample Insurance Appeal Letter for Implant Removal/Exchange
Read our XRAY review for a more in-depth analysis of the recall and related issues.
See the "Related Resources" box below for more history behind this new guidance, recall, and FDA meetings that took place earlier this year.
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