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Important Notes About Breast Implant Safety

Breast implants are safe, but no medical device is without risks. In rare instances, some breast implant patients have developed breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a highly treatable type of lymphoma that can develop around breast implants (for more information, visit plasticsurgery.org/alcl-info). There also exists a small population of patients who have attributed symptoms of rare diseases to their breast implants, but decades of research have yet to establish a causal relationship between the device and systemic disease.

Patients can rest assured that no one is more committed to ensuring the safety of these devices than our specialty – and we will continue collecting long-term data through surveillance efforts like the National Breast Implant Registry (NBIR). As the U.S. Food and Drug Administration (FDA) prepares to convene a hearing on breast implant safety in 2019, collaborative efforts among ASPS, The PSF and the FDA in establishing the PROFILE registry (to track and better understand BIA-ALCL) and, most recently, the NBIR (to monitor breast implants) will continue to provide valuable data long into the future.

Breast Implant Safety

The American Society of Plastic Surgeons takes all patient safety concerns seriously.

Breast implants are FDA-approved and safe devices that offer many quality-of-life benefits for women. Hundreds of thousands of patients each year opt for breast implants and report no adverse effects. When a possible association with a rare disease is reported, plastic surgeons follow the science to provide detailed, accurate information for full patient consent and decision making.

Breast implants are among the most studied medical devices in the world, and they will continue to be. 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.

As noted, breast implants have been studied worldwide for decades, and the scientific literature shows no causal relationship between the device and autoimmune diseases. That's not to say a patient could not have a negative reaction to any medical device, and if a woman desires to have her breast implants removed – for any reason – she should consult her plastic surgeon.

Breast implants remain an important option for breast reconstruction and augmentation. Like any medical device, breast implants carry a risk of complications, and in the event any complication develops, patients should consult their plastic surgeon to address it in a timely manner.

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.

ASPS, The PSF and the FDA 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. 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.

BIA-ALCL

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. The current lifetime risk of BIA-ALCL is estimated to be 1:3817 - 1:30,000 for women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. Since the initial case report in 1996, ASPS now recognizes approximately 257 cases in the US and a total of 656 worldwide as of December 5, 2018.

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, including asymmetry, 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.

The FDA recommends that all cases of BIA-ALCL be reported to the FDA and to the PROFILE registry at ThePSF.org/PROFILE. ASPS also offers a wealth of BIA-ALCL information for patients at plasticsurgery.org/alcl-info and for surgeons at plasticsurgery.org/alcl.

Informed Consent

ASPS develops and makes available to members informed-consent resources and emphasizes the need to clearly inform potential patients of any risks associated with any procedure or device.

ASPS takes all patient concerns seriously. Through its registries, scientific journals, educational offerings and support for research, ASPS and The PSF will continue to keep its members and the specialty informed of the latest science and techniques to improve patient safety.

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