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Implant Safety

Breast implants are FDA-approved devices and are an important option for breast reconstruction and breast augmentation.

Breast implants have been studied and placed worldwide for decades and hundreds of thousands of patients have breast implants placed every year and report no adverse effects.

Like any medical device, breast implants do have a complication risk but also have great benefit for our patients. In order to reduce complications, specific attention is placed on surgical technique, intraoperative antibiotics, patient activity restrictions, and post surgical oral antibiotics. Implants are also monitored with an implant protocol breast MRI every 5 years to ensure the breast implant is intact.

Patient safety is our number one concern. Dr. Spiegel is dedicated to patient advocacy, advances in breast surgery, and medical safety. Textured breast implants have been associated with a rare and highly treatable type of lymphoma named breast implant-associated anaplastic large cell lymphoma, or BIA ALCL. Breast implants can either have a textured or smooth shell. BIA ALCL has been associated with the texturing of the implant shell, not breast implants in general. Data shows when this rare disease occurs, it has occurred more frequently in patients who have breast implants with a textured surface. Dr. Spiegel’s current practice uses only smooth breast implants and tissue expanders.

Dr. Spiegel served on the American Society of Plastic Surgeons BIA ALCL Subcommittee and she continues to provide up to date information for our patients. Please see below for links to additional breast implant safety and BIA ALCL resources. You can also find links to current events to keep yourself informed and updated.

Current Events

July 2019
FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market .

https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

September 2019
Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA ALCL Cancer

https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer

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