UNK Mammary Implant
Received Jul 27, 2026 · Event occurred Jun 11, 2026
Report 9617229-2026-14077 · MDR key 50021880
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
UNK Mammary Implant
Product problems
- Device Appears to Trigger Rejection
- Material Rupture
- Malposition of Device
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Literature review titled ¿Predicting device-related complications among women undergoing breast implant surgeries¿ reported ¿device rupture/deflation, capsular contracture, and device malposition¿. This record is for an unknown side. Device was explanted. The number of patients involved is unknown.
Additional Manufacturer Narrative
This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.Further information from the reporter regarding event, product, or patient details has been/will be requested. No additional information is available at this time. The Reason(s) for reoperation is/are: device rupture/deflation, capsular contracture grade unknown, and device malposition.The reported events (capsular contracture grade unknown) are physiological complications, and device analysis typically does not help Allergan determine the cause.Article Citation: Earnest, Arul et al. ¿Predicting device-related complications among women undergoing breast implant surgeries.¿ Journal of plastic, reconstructive & aesthetic surgery : JPRAS, vol. 119 164-176. 11 Jun. 2026, doi:10.1016/j.bjps.2026.06.003.