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Breast Implant Safety

Creator:   Plastic and Reconstructive Surgery
Updated:   9/27/2018
Contains:  30 items
In this era of enhanced patient safety and outcomes and increased scrutiny of medical devices, the safety of breast implants in both aesthetic and reconstructive surgery has yet again become a topic in the spotlight. Breast augmentation is one of the most popular aesthetic procedures performed and implant-based breast reconstruction represents ~80% of all breast reconstructions. It is important for surgeons to have access to the data regarding these devices. This PRS Collection contains scholarly articles published in Plastic and Reconstructive Surgery addressing this topic. Implant safety, longevity, complications and patient outcomes are addressed.

This robust collection highlights the science behind breast implant safety, and was compiled by Breast Section Editor, Joseph Disa, MD.



For further reading on this topic:

- Safety of Silicone Breast Implants. Institute of Medicine (US) Committee on the Safety of Silicone Breast Implants
- Silicone Gel Breast Implants: What We Know About Safety After All These Years. Ann Intern Med. 2016 Feb 2;164(3):199-200.
- Lactation Outcomes in More Than 3500 Women Following Primary Augmentation: 5-Year Data From the Breast Implant Follow-Up Study. Aesthet Surg J. 2018 Aug 27.
- Long-Term Safety of Textured and Smooth Breast Implants. Aesthet Surg J. 2017 Dec 13;38(1):38-48.
- Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review. Ann Intern Med. 2016 Feb 2;164(3):164-75.
- Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel. Aesthet Surg J. 2015 May;35 Suppl 1:S3-10.
- Natrelle saline-filled breast implants: a prospective 10-year study. Aesthet Surg J. 2009 Jan-Feb;29(1):19-25.
- The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence. Ann Plast Surg. 2007 Nov;59(5):569-80.
- A robust collection of ALCL and Breast Implants articles from PRS

Ten-year Core Study Data for Sientra’s Food and Drug Administration–Approved Round and Shaped Breast Implants with Cohesive Silicone Gel

Stevens, W. Grant; Calobrace, M. Bradley; Alizadeh, Kaveh; More

Plastic and Reconstructive Surgery. 141(4S):7S-19S, April 2018.

Breast Cancer following Augmentation Mammaplasty: A Case-Control Study

Sosin, Michael; Devulapalli, Chaitan; Fehring, Charles; More

Plastic and Reconstructive Surgery. 141(4):833-840, April 2018.

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Five-Year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants

Singh, Navin; Picha, George J.; Hardas, Bhushan; More

Plastic and Reconstructive Surgery. 140(4):666-679, October 2017.

  • Coding Perspective

Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants

McGuire, Patricia; Reisman, Neal R.; Murphy, Diane K.

Plastic and Reconstructive Surgery. 139(1):1-9, January 2017.

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Safety of Tissue Expander/Implant versus Autologous Abdominal Tissue Breast Reconstruction in Postmastectomy Breast Cancer Patients: A Systematic Review and Meta-Analysis

Tsoi, Bernice; Ziolkowski, Natalia I.; Thoma, Achilleas; More

Plastic and Reconstructive Surgery. 133(2):234-249, February 2014.

Risk Factor Analysis for Capsular Contracture: A 5-Year Sientra Study Analysis Using Round, Smooth, and Textured Implants for Breast Augmentation

Stevens, W. Grant; Nahabedian, Maurice Y.; Calobrace, M. Bradley; More

Plastic and Reconstructive Surgery. 132(5):1115-1123, November 2013.

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