https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-two-breast-implant-manufacturers-part-ongoing-efforts-protect-patients?utm_campaign=2020-05-14%20FDA%20Issues%20Warning%20Letters%20to%20Breast%20Implant%20Manufacturers&utm_medium=email&utm_source=Eloqua

FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients

Today, as part of our commitment to protect patients and ensure the safety of breast implants, the U.S. Food and Drug Administration (FDA) issued warning letters to two manufacturers: Allergan for failing to comply with requirements to conduct post-approval studies to assess the long-term safety and risks of the NATRELLE Silicone-Filled Breast Implants and the NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants. Ideal Implant Incorporated for failure to comply with quality systems and medical device reporting regulations as observed in the inspection conducted in early 2020.

Read Press Release Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education .