A Board Certified Plastic Surgeon Explains the New FDA Breast Implant Guidelines
In October of 2021, the FDA announced new guidance for breast implant manufacturers and plastic surgeons. The guidance is primarily intended to help you make a fully informed decision about breast augmentation.
Board Certified Plastic Surgeon Dr. Emily Kirby explains what you need to know about these changes, whether you are considering breast implants or already have them.
What are the new FDA breast implant guidelines?
The new FDA guidelines instruct breast implant manufacturers to change some of the ways they communicate with patients about the risks and maintenance of implants. They also adjust some recommendations for surgeons and patients. Here is a general overview of the changes, which took effect in November of 2021:
- Breast implants now carry a boxed warning explaining that breast implants are not lifetime devices, meaning that you may need future surgery to remove or replace your implants, and also detailing the potential risks of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII).
- Breast implant product labeling has been updated and now includes a list of the materials used to manufacture your breast implants. Full information about your implants is detailed in a lengthy document from the implant manufacturer, provided by your surgeon.
- Implants require a Patient Decision Checklist that you and your surgeon review and both sign prior to surgery to confirm that you understand the risks and benefits of breast implants.
- The general screening recommendations for silicone implants have been updated: the FDA recommends an MRI or ultrasound after 5-6 years, with repeat screenings every 2-3 years thereafter.
- Your implants come with patient device cards, which detail what kind of implants you have in case you need to reference this in the future. (A reputable plastic surgery practice will also keep record of this, should you need it.)
How does this change my breast implant consultation with a plastic surgeon?
With an ethical, board-certified plastic surgeon, this labeling will likely make only a small difference in your breast augmentation experience. The primary change is that you will sign a Patient Decision Checklist, which consists of several pages of information summarizing risks, benefits, and research-based evidence on breast implants.
At Kirby Plastic Surgery, we have always gone into detail with patients about the risks and benefits of breast implants; the new required checklist simply makes it official that we have covered certain topics. When you visit our Fort Worth office for a consultation, we will go into greater depth on the subject, discussing your aesthetic goals, lifestyle ramifications, available implant options, incision choices, breast implant risks, and more. You will have plenty of time to ask Dr. Kirby all of your questions about breast implants and breast augmentation surgery.
If breast implants are considered to be safe, why did the FDA issue new recommendations?
Today’s FDA-approved breast implants are extensively researched. Yet as research continues, it is to be expected that adjustments to guidelines will periodically be released by the FDA.
The FDA routinely monitors ongoing breast implant safety studies and also organizes panels of experts to review new data. Dr. Kirby serves as a Principal Investigator for one of the many FDA-monitored breast implant research studies. A 2019 panel discussion led the FDA to believe that some patients did not fully understand risks associated with breast implants. The new recommendations address this concern, making the following clearer to any patient receiving breast implants:
- Breast implants are not lifetime devices, and may need to be replaced or removed in the future.
- It is recommended that silicone gel-filled breast implants undergo routine check-ups with an MRI or ultrasound to monitor for implant rupture.
- Breast implants have been associated with a very low risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system that is more common in patients with textured implants. Some of these implants have now been recalled.
- Some women report a collection of systemic symptoms referred to as breast implant illness (BII). The risk of BII has not been well established, and there is much to learn before it can be defined as a specific disease; still, some affected patients have found that their symptoms resolve after removing their breast implants. BII is the topic of ongoing investigational studies at this time.
Choose a breast implant surgeon who consistently puts your safety first
Fort Worth Board Certified Plastic Surgeon Dr. Emily J. Kirby prioritizes your safety. With over a decade of experience in plastic surgery, Dr. Kirby is board certified by the American Board of Plastic Surgery (ABPS) and served as Chief of Plastic Surgery at Texas Health Resources Harris Methodist hospital, the largest hospital in Fort Worth. To learn more or schedule your breast augmentation consultation, call or text 817-292-4200 or contact us online today.