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Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate
AUDIENCE: Plastic Surgery, Oncology, Patient
ISSUE: FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. 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. BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.
- See the FDA Update for additional information, including a summary of Medical Device Reports and medical literature, and recommendations for patient care.
BACKGROUND: In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. FDA continues to collect and evaluate information about ALCL in women with breast implants.
RECOMMENDATION: Healthcare providers: If you have patients with breast implants, you should continue to provide them routine care and support. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended. Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturers’ labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
Patients: Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants. If you already have breast implants, there is no need to change your routine medical care and follow-up.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch alert, including a link to the FDA Drug Safety Communication, at: