FDA Guidelines for Breast Implant Surgery

Breast augmentation surgery continues to be the most popular cosmetic surgical procedure in the U.S. and elsewhere. Yet, there are several issues of side-effects and potential complications that must be considered by any woman who is contemplating surgical breast enhancement. According to the U.S. Food and Drug Administration (US FDA), the issues that need to be considered are:

  • Local complications are the primary safety issue with breast implants because they are frequent enough to be a concern.
  • Local complications accumulate over the lifetime of the implant, and they have not been well studied.
  • Information on local complications is crucial for women deciding whether or not they want breast implants.

Key points to consider whether you are undergoing breast augmentation, reconstruction, or revision:

  • Breast implants will not last a lifetime. Either because of rupture or other complications, you will likely need to have the implants removed.
  • You are likely to need additional doctor visits and reoperations because of one or more complications over the course of your life.
  • You are likely to have the implants removed, with or without replacement, because of one or more complications over the course of your life.
  • Many of the changes to your breast following implantation may be cosmetically undesirable, as well as irreversible (cannot be undone).
  • If you later choose to have your implants removed, you may experience unacceptable dimpling, puckering, wrinkling, loss of breast tissue, or other undesirable cosmetic changes of the breast.

The US FDA has published the FDA Breast Implant Consumer Handbook which should be considered to be essential reading for any woman seriously contemplating breast augmentation surgery.

Because of the many problems and complications involved in such surgery, we consider natural breast enhancement to be a far better option.

1 Comment

  1. Marshall Zobel

    Awesome site you have here but I was curious if you knew of any user discussion forums that cover the same topics talked about here? I’d really like to be a part of online community where I can get opinions from other experienced people that share the same interest. If you have any suggestions, please let me know. Bless you!

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