- Home
- Editorial
- News
- Practice Guidelines
- Anesthesiology Guidelines
- Cancer Guidelines
- Cardiac Sciences Guidelines
- Critical Care Guidelines
- Dentistry Guidelines
- Dermatology Guidelines
- Diabetes and Endo Guidelines
- Diagnostics Guidelines
- ENT Guidelines
- Featured Practice Guidelines
- Gastroenterology Guidelines
- Geriatrics Guidelines
- Medicine Guidelines
- Nephrology Guidelines
- Neurosciences Guidelines
- Obs and Gynae Guidelines
- Ophthalmology Guidelines
- Orthopaedics Guidelines
- Paediatrics Guidelines
- Psychiatry Guidelines
- Pulmonology Guidelines
- Radiology Guidelines
- Surgery Guidelines
- Urology Guidelines
Breast Implant-Associated Lymphoma: FDA Issues new information
The US Food and Drug Administration (FDA) has provided an update on breast implant-associated anaplastic large cell lymphoma.
In January 2011, the agency identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL).
"The FDA has been closely tracking the relationship between breast implants and a rare type of non-Hodgkin's lymphoma since we first identified this possible association. We’ve been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “As part of that effort, we are working to update and enhance the information we have on this association, including updating the total number of known cases of BIA-ALCL and the lifetime risk of developing BIA-ALCL as reported in medical literature. We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand and provide updates about this important public health issue"
The agency is providing an updated number of medical device reports (MDRs) (also known as adverse event reports) and medical literature estimates regarding risk reviewed by the agency since the last public update in March 2017. We are reporting that we are aware of 414 total cases of BIA-ALCL. Additionally, studies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.
The agency is also updating the content and format of the webpage for the agency’s breast implant post-approval studies to make current information about these important studies easier for patients to read and understand.
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL).
At that time, the FDA knew of so few cases of ALCL that it was not possible to determine what factors increased a patient’s risk. In a report summarizing the Agency's findings, FDA emphasized the need to gather additional information to better characterize ALCL in individuals (cis- and transgender women and men) with breast implants.
Over time, FDA has strengthened the understanding of this condition. In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in worldwide reporting and lack of global breast implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.
Today’s update does not change the agency’s recommendations regarding breast implants. Choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the complete information about risks and benefits.
Know and Consider the Risks
FDA-approved breast implants sold in the United States are made with outer shells of medical-grade silicone and filled with silicone gel or saline. These implants undergo extensive testing to establish reasonable assurance of safety and effectiveness.
Nonetheless, there are risks associated with all breast implants, including:
- additional surgeries
- breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a cancer of the infection-fighting cells (lymphocytes) of the immune system
- capsular contracture, which is scar tissue that squeezes the implant
- breast pain
- rupture (tears or holes in the shell) with deflation of saline and silicone gel-filled implants
- silent (without symptoms) rupture of silicone gel-filled implants
Note: The silicone used for breast implants is different than injectable silicone. Injectable silicone is not FDA-approved for body contouring.
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd