Breast Implants: What Patients Need to Know
Breast implants are FDA-approved devices that offer many quality-of-life benefits for patients. Each year, hundreds of thousands of patients undergo breast implant procedures worldwide. Breast implants remain an important option for breast augmentation and breast reconstruction procedures.
Collaboration among the scientific community, patient advocacy groups and governments from around the world will continue to enhance the device and ensure the global plastic surgery community works together to keep all parties educated about the latest news and advancements to improve patient safety.
Breast Implant Procedures
Patients considering breast implants should seek out a board-certified plastic surgeon to help weigh the benefits and potential risks to make the best possible decision.
For more information on cosmetic breast implant procedures, please visit our procedure pages:
For more information on reconstructive breast implant procedures, please visit our Breast Reconstruction procedure page.
For more information on gender-affirming breast implant procedures, please visit our Transfeminine Top Surgery procedure page.
Breast Implant Safety
FDA-approved breast implants undergo extensive testing to demonstrate reasonable assurance of safety and effectiveness. The vast majority of people with breast implants experience no serious complications. However, there are risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms commonly referred to as breast implant illness (BII) that some patients attribute to their implants, which can include fatigue, "brain fog," muscle or joint pain and rash. In the event any complication develops, patients should consult a board-certified plastic surgeon to address it in a timely manner. Likewise, if a patient desires to have breast implants removed – for any reason – she should consult her plastic surgeon.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare and highly treatable type of lymphoma that can develop around breast implants. Data show BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces.
Most patients with BIA-ALCL have an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule. Continued follow-up after any breast implant surgery is suggested and important for patient health, but patients who notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape should contact their plastic surgeon.
In most cases, women diagnosed with BIA-ALCL observed changes in the look or feel of the area surrounding the implant greater than one year after their initial surgical sites were fully healed, and on average eight-to-ten years after receiving textured implants.
For more information about BIA-ALCL, please visit PlasticSurgery.org/ALCL-Info.
In collaboration with the FDA and breast implant manufacturers, ASPS and The PSF launched the National Breast Implant Registry (NBIR) in September 2018 to collect information on breast implant procedures to help improve the quality of care for all patients.
Research takes time, which is why the NBIR is important. The NBIR will collect information on breast implant procedures – patient demographics, surgical techniques, types of devices, etc. – and the information will be used to improve the quality of care for all patients. The NBIR is designed to find trends in breast implant procedures and identify potential complications, so breast implant manufacturers can use the information to further study the safety of their products. For more information, please visit ThePSF.org/NBIR.
In collaboration with the FDA, ASPS and The PSF launched the PROFILE registry to increase the scientific data on ALCL in women with breast implants. The primary goal of this collaboration is to better understand the role of breast implants in the etiology of BIA-ALCL. The research also will focus on identifying potential risk factors and criteria detection and management of this disease.
PROFILE data is routinely reviewed and analyzed. Data summaries comparing PROFILE data to FDA data are performed monthly and are available online to the public. In 2019, the first PROFILE manuscript containing an in-depth data analysis was published in Plastic and Reconstructive Surgery.
For more information, please visit ThePSF.org/PROFILE.