Breast Implants: The View From the FDA

Binita Ashar, MD, MBA, FACS; David Krause, PhD; Laurie Scudder, DNP, NP

Disclosures

July 17, 2013

Editorial Collaboration

Medscape &

In This Article

The Long-term View

Medscape: Can you discuss potential long-term, systemic safety concerns, including connective tissue disorders and malignancies?

Dr. Krause: The postapproval studies to date do not show evidence that silicone gel-filled breast implants cause connective tissue disease or reproductive problems. There does seem to be an association between breast implants and the development of lymphoma immediately surrounding the implant, but this is a very rare occurrence. In most of the reported cases, the lymphoma was detected by the patient when she noticed changes in the look or feel of the area around the implant. So we recommend that patients be aware and check for changes in this area, especially unilateral swelling or pain, and that they contact their healthcare provider if they observe such changes.

Dr. Ashar: More descriptive information about other potential complications, including difficulty with lactation, can also be found in the summary of safety and effectiveness in the labeling. (Editor's Note: Links to the device-specific SSED can be found in the Table.)

Table. Summary of Safety and Effectiveness Data for FDA-Approved Breast Implants

Device Approval Date Safety and Effectiveness Information
Saline-filled breast implants May 2000 Mentor Saline Breast Implants
May 2000 Allergan (formerly called McGhan and Inamed) Medical RTV Saline-Filled Breast Implant
Silicone gel-filled breast implants November 2006 Allergan Inamed®
February 2013 Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
November 2006 Mentor MemoryGel®
June 2013 Mentor MemoryShape™ Silicone-Filled Breast Implants
March 2012 Sientra Silicone Gel Breast Implants

FDA = US Food and Drug Administration

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