FDA Releases New Breast Augmentation Guidelines


 As part of its effort to keep people informed and healthy, the Food and Drug Administration (FDA) occasionally releases guidelines for products including medications, cosmetic products, and even prosthetic devices such as breast implants.

Recently, the FDA issued new guidelines for breast implants, updating the guidelines published in 2019. These new guidelines encourage consumers to read the risks associated with breast implants prior to undergoing breast augmentation surgery, including the risk of rupture to gel-based implants. They recommend that manufacturers put a warning on the implant packaging, and include a patient checklist to make sure the patient is ready for the responsibility of receiving breast implants.

Another recommendation is that patients are encouraged to receive regular screenings to make sure their implants are in good health and have not ruptured. This can be performed via ultrasound or MRI.

While surgeons agree with the new guidelines, many are reportedly dismayed that there was no mention in the new guidelines of seeking a board certified plastic surgeon to perform a breast augmentation. This, some argue, will mitigate the risk of implant rupture, because a skilled surgeon will know the correct placement for implants. Placement is important, because a correctly placed implant is less likely to rupture.

Board certification ensures that your surgeon is up to date on the safest, most effective plastic surgery techniques, and that he or she is performing satisfactory surgeries. Boards regularly review members to make sure their patients are happy with procedures, and surgeons who do not perform well can be reported to the board and subsequently dropped if they do not meet the board's strict criteria.

As for undergoing breast augmentation, we recommend patients do their research before undergoing any plastic surgery procedure. This means not just getting a procedure for the right reasons, but also asking any questions and making sure you are prepared for the care and maintenance of your surgical procedure.

If you are considering a procedure like breast augmentation, speak to Dr. Mitchell about your options, including the type of implant, the care of your implants, and your motivation for undergoing the breast augmentation surgery in the first place.

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