Breast Implants

What the New FDA Breast Implant Regulations May Mean for You

Breast Implant - Martin - March22

On October 27, 2021, the US Food and Drug Administration (FDA) issued new safety protocols for breast implants used in breast augmentation procedures. These new requirements are designed to ensure that healthcare providers give sufficient information and clearly communicate the possible risk factors associated with breast implants to their patients before breast augmentation surgery.

As someone considering breast augmentation, what does this mean for you?

What are the New FDA Breast Implant Regulations?

The FDA spent two years gathering data on two potential risks associated with breast implants: anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness. After gathering this data, the FDA felt that it was necessary to put in place requirements that help ensure that all patients considering breast implants be provided with complete risk information in order to be able to make an informed decision.

These new FDA requirements require new labeling for all legally marketed breast implants, ensuring it includes the following:

  • A boxed warning – This warning lists all potential risks directly on the packaging.
  • Patient decision checklist – This is a checklist designed to be reviewed with the patient by the healthcare provider. The checklist goes over all the potential risks associated with breast implants and is designed to ensure that every patient has a thorough understanding of these risks. The list must then be signed by the patient and the surgeon implanting the breast implants.
  • Silicone gel rupture screening recommendations – This is a list of the updated screening recommendations for those receiving silicone gel implants.
  • Implant description – This is an ingredient label for the breast implants, listing all material included in the construction of the implant.
  • Patient device card – This card is given to the patient and provides detailed information regarding their specific implant.

Why Did the FDA Enact These New Regulations?

Information about potential breast implant risks, such as infection, ruptures, and capsular contracture (scarring around the implant) has always been a part of the FDA safety recommendations. However, after a two year look at additional conditions (BIA-ALCL and breast implant illness), the FDA determined that these conditions needed to be included in the safety information shared with potential breast augmentation patients.

While BIA-ALCL occurs in approximately 1 in 450 women with textured breast implants, breast implant illness is more common, though still not accepted as an actual condition by everyone in the medical community. This condition can cause chronic fatigue, joint pain, hair loss, breathing problems, and cognitive difficulties.

What Does This Mean for Your Breast Augmentation?

The idea behind these new guidelines is not to prevent the use of breast implants, but rather to ensure that patients make their breast augmentation decision after having all the risk information explained to them before they make this decision.

The goal is to encourage everyone considering breast implants to have a thorough conversation with their medical professionals to address the risks, benefits, and possible alternatives to breast augmentation and breast implants.

An Alternative Option to Breast Implants

For those who feel the risks outweigh the benefits, there are alternatives to breast implants. Autologous breast augmentation, or fat transfer breast augmentation, uses your own body fat to increase your breast volume. Fat is collected from areas of your body (abdomen, love handles, thighs, or buttocks) through liposuction and then purified.

Once purified, the fact is then injected into the breast to add volume. Because the fat is your own, there is minimal risk associated with this procedure. This augmentation option only works for those looking for a relatively small increase in breast size.


What the New FDA Breast Implant Regulations May Mean for You
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What the New FDA Breast Implant Regulations May Mean for You
Dr. Scot Martin in Las Cruces, New Mexico explains the new FDA guidelines for breast implants and how these guidelines affect your breast augmentation.
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