The USA FDA have released updated information regarding breast implant related ALCL (Anaplastic Large Cell Lymphoma)
Following the report, the USA ASPS (American Society of Plastic Surgeons) and ASAPS (American Society of Aesthetic Plastic Surgery) have released a joint advisory statement
FDA report overview:
The FDA reported that there were 34 detailed analysis of breast implant related ALCL in 2011.
After summarising the MAUDE database, which includes 258 medical device reports (MDR)s, the FDA now estimates that the total number of ACLC cases in the USA to be between 100-250.
USA ASPS and ASAPS believe the risk to women with implants is very low. Breast implant related ACLC ‘is an extremely rare and highly treatable type of lymphoma that can develop around breast implants. BL-ACLC is not cancer of the breast tissue’ – Read more
FDA advice for patients:
The FDA advises that women with breast implants do not need to change their medical care or follow up.
- Monitor your implants and report any changes to your health care provider: For information on brea exams, see MedicinePlus: Breast Self Exam
- Continue with your routine mammogram screening
- Consider periodic MRI scans are recommended to detect ruptures for silicone filled implants as recommended by your health care practitioner
Useful resources:
• Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: FDA Safety Communication
•Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses
•FDA Advises Women with Breast Implants About Risk of Rare Lymphoma
•Questions and Answers about Anaplastic Large Cell Lymphoma (ALCL)
•Medical Device Reports of Breast Implants in Women with ALCL