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Things to Consider Before Getting Breast Implants

Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Final Guidance

The final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, provides recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants, including:

  • Boxed warning (page 4 of the guidance)
  • Patient decision checklist (page 5 of the guidance)
  • Materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants
  • Silicone gel-filled breast implant rupture screening recommendations
  • Patient device card

The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006.

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This overview provides seven key things you should know if you are considering breast implants.

There are several important things to consider before deciding to undergo breast implant surgery. Below are some things the FDA thinks you should consider before undergoing breast augmentation, reconstruction or revision surgery.

  • Breast implants are not lifetime devices; the longer you have your implants, the more likely it will be for you to have them removed or replaced.
  • You should assume that you will need to have additional surgeries (reoperations) because breast implants are not lifetime devices and complications can occur.
  • Even if you have complications, the cost of implant removal or implant replacement may not be covered by insurance.
  • The longer you have breast implants, the more likely you are to experience local complications and adverse outcomes, which may be cosmetically undesirable and irreversible.
  • The most common local complications and adverse outcomes are capsular contracture, reoperation and implant removal. Other complications include rupture or deflation, wrinkling, asymmetry, scarring, pain, and infection at the incision site. For a more complete list of complications and adverse outcomes that may occur for a specific breast implant, you should ask your surgeon for the manufacturer’s patient labeling and educational materials.
  • Read the manufacturer’s patient labeling and other educational materials carefully and discuss any questions you have with your surgeon before deciding.
  • There are different shapes, styles and textures of breast implants; discuss your goals and expectations and the benefits and risks of breast implants with your surgeon.
  • If you have your implants removed but not replaced, you may experience changes to your natural breasts such as dimpling, chest wall concavity, puckering, wrinkling, breast tissue loss, or other undesirable cosmetic changes.
  • Breast implants need to be monitored for as long as you have them.  For patients with silicone gel filled breast implants, your healthcare provider may recommend that you have regular exams using magnetic resonance imaging (MRI) or ultrasound which may not be covered by your insurance, to screen for breast implant rupture and other complications.
  • If you notice any abnormal changes in your breasts or implants, you will need to see your surgeon or health care provider promptly.
  • There is a risk of developing a type of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the breast or scar tissue (capsule) surrounding the implant. BIA-ALCL is not breast cancer. Treatment of BIA-ALCL involves removal of the implant and the capsule surrounding the implant and some patients have required chemotherapy and/or radiation therapy. 
  • Although treatable, there is a risk of death for patients diagnosed with BIA-ALCL.
  • Some breast implant patients report a variety of systemic symptoms, such as chronic fatigue, brain fog, joint and muscle pain, which may not meet the diagnostic criteria to be categorized as a disease. Patients refer to these symptoms collectively as “breast implant illness (BII).”  In some cases, patients report that removal of their breast implants without replacement appears to reverse their symptoms.
  • Breast reconstruction often involves the implantation of not only a breast implant device but also a surgical mesh device. The benefit of implanting a surgical mesh as part of the breast reconstruction operation has not been reviewed by the FDA.

FDA Communication

 

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