NEWSLETTER
What’s New?
LATEST INFORMATION ABOUT ALCL
Background
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, we emphasized the need to gather additional information to better characterize ALCL in individuals (cis- and trans-gender women and men) with breast implants.
Over time, we have strengthened our 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 world-wide reporting and lack of global breast implant sales data. At this time, most data suggest that BIA-ALCL occurs following implantation of breast implants with textured surfaces rather than those with smooth surfaces.
As of September 30, 2018, the FDA had received a total of 660 medical device reports (MDRs) of BIA-ALCL, including the death of nine patients. Of the 660 total BIA-ALCL related MDRs the FDA received, many MDRs were identified as duplicate reports, including additional follow-up reports that were submitted to the FDA. The FDA has carefully reviewed the 660 MDRs to provide a more accurate analysis and to only provide unique BIA-ALCL reports. The resulting data reflected a total of 457 unique MDRs for BIA-ALCL.
According to the International Society of Aesthetic Plastic Surgery (ISAPS), a worldwide professional body for board-certified aesthetic plastic surgeons, more than 1.4 million women underwent breast augmentation surgery in 2017. The American Society of Plastic Surgeons (ASPS) reports 300,378 in the US alone. At present, less than 0.03% of women with breast implants have been diagnosed with implant-related ALCL.
An excerpt from the FDA advises the following to patients, “If you have breast implants, there is no need to change your routine medical care and follow-up. BIA-ALCL is rare. Although not specific to BIA-ALCL, you should follow standard medical recommendations including:
- Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.
- If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.
The complete article can be found at the following link: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
In summary, if a patient has experienced no problems, there is no reason for implant removal. If there are problems, removal of the scar capsule and the implant is usually curative.
Additionally, The American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) have published a joint statement addressing breast implant associated ALCL which can be found at the following: https://www.surgery.org/downloads/blasts/BIA-ALCL/
The American Society of Plastic Surgeons (ASPS) is the largest plastic surgery specialty organization in the world. Founded in 1931, the Society represents 94% of all board-certified plastic surgeons in the U.S., and more than a thousand plastic surgeons worldwide, making ASPS a global institution and leading authority on cosmetic and reconstructive plastic surgery. The mission of ASPS is to advance quality care to plastic surgery patients by encouraging high standards of training, ethics, physician practice and research in plastic surgery. To support its members in the provision of excellent patient care, ASPS will provide: education, advocacy, practice support and enhanced public awareness of the value of plastic surgery, while fostering the highest professional, ethical, and quality standards. The Society is a strong advocate for patient safety and requires its members to operate in accredited surgical facilities that have passed rigorous external review of equipment and staffing.
The American Society for Aesthetic Plastic Surgery (ASAPS), founded in 1967, is the leading professional organization of plastic surgeons certified by the American Board of Plastic Surgery who specialize in aesthetic (cosmetic) plastic surgery. With more than 2500 members (all categories) in the U.S and Canada, as well as international members in many other countries, ASAPS is at the forefront of innovation in aesthetic plastic surgery around the world.
The mission of the American Society for Aesthetic Plastic Surgery includes continuing medical education, public education and patient advocacy. ASAPS is an educational organization, sponsoring scientific meetings on the latest advances in cosmetic plastic surgery. ASAPS meetings are designed for attendance by qualified plastic surgeons. ASAPS is an accredited sponsor of Continuing Medical Education (CME). Aesthetic Surgery Journal, an official publication of ASAPS, is the most widely read clinical journal of aesthetic surgery. ASAPS is a research organization, collecting data on aesthetic surgery, publishing annual statistics on the number of cosmetic procedures performed, and supporting scientific and clinical studies in aesthetic surgery. ASAPS is a public information organization, providing accurate and timely information on all aspects of surgery through this web site and by working extensively with the news media through our Communications Office in New York City.
ASAPS is a patient advocacy organization, promoting the highest standards of professional conduct among our members as well as representing the rights of patients to be fully informed about the training and credentials of their doctors and the risks and benefits of cosmetic surgery.
Debra Messing for CoolSculpting
*Video from CoolSculpting.com
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