Breast Implants

What is Breast Implants?

Breast implants are medical devices that are surgically put beneath the breast tissue or the chest muscle to increase breast size (augmentation) or to replace breast tissue that has been lost due to cancer or trauma, or that has failed to develop properly due to a serious breast deformity (reconstruction). They’re also employed in revision operations, which aim to improve or correct the outcome of a previous procedure.

Breast implants are available in two forms in the United States: saline-filled and silicone gel-filled. The outside shells of both varieties are silicone. Size, shell thickness, shell surface texture, and form all vary (contour).

A breast implant is a prosthesis that is used to alter a person’s breast size, shape, and contour. Breast implants can be used in reconstructive plastic surgery to restore a natural-looking breast after a mastectomy, to address congenital abnormalities and deformities of the chest wall, or to aesthetically enhance the breast through breast augmentation surgery.

Breast pain, skin changes, infection, rupture, and a fluid accumulation around the breast are all possible implant complications.

The information on this page is intended to supplement rather than replace the conversation between a patient and a physician. This information has been provided to assist women in making educated decisions about whether or not to get breast implants:

Describe the hazards of breast implants and the surgical techniques that are used to place them.

  • Provide data supporting a reasonable assurance of safety and effectiveness, approval letters, labeling, and information on post-approval studies for saline-filled and silicone gel-filled breast implants.
  • Inform women with breast implants about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
  • Encourage patients to report breast implant-related adverse events to the FDA’s Medwatch program.

Breast Implants: FDA Recommendations

  • Certain Labeling Recommendations for Breast Implants to Improve Patient Communication (2020): Provides content and format recommendations for certain labeling information for saline and silicone gel-filled breast implants, such as:
  • Warning in a box (page 4 of the guidance)
  • Checklist for patients making decisions (page 5 of the guidance)
  • Types and quantities of chemicals and heavy metals detected in or emitted by breast implants are described in the materials/device descriptions.
  • Breast implant rupture screening recommendations for silicone gel-filled implants
  • Card for the patient’s device

The FDA’s Saline, Silicone Gel, and Alternative Breast Implants advice, which was issued September 29, 2020 and superseded the previous version dated November 17, 2006, supplements the recommendations in this guidance.

The revised labeling, which was authorized on October 27, 2021, reflects the FDA’s September 2020 guidance on labeling suggestions.

  • Breast Implants: Saline, Silicone Gel, and Alternatives (2006)
Breast Implants

 

Breast Implant Sales and Distribution Restrictions

The Post-Market Approval (PMA) Supplement Approval letter for these implants contains the limits on sale and distribution.

  • Breast Implants Allergan Natrelle Silicone Gel-Filled Allergan Natrelle Silicone Gel-Filled Allergan Natrelle Silicone Gel-
  • Breast Implants with a Structured Design (IDEAL Implant Structured Breast Implants)
  • Mentor Recall
  • Breast Implants with Silicone Filling
  • Mentor Recall
  • Breast Implants with Silicone Gel Filling
  • Breast Implants: Mentor Saline-Filled and Spectrum
  • Breast Implants Allergan Natrelle Saline
  • Breast Implants Sientra OPUS Silicone Gel
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