A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling:
potential adverse events that may occur with saline-filled breast implant surgery include: reoperation, pain, wrinkling, asymmetry, implant palpability/visibility, implant removal, capsular contracture, changes in nipple and breast sensation, implant displacement/migration, implant deflation, scarring, infection, hematoma/seroma, breastfeeding complications, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.Deflation ¿ breast implants are not lifetime devices.Saline breast implants deflate when the shell develops a tear or hole.Deflation can occur at any time after implantation, but they are more likely to occur the longer the implant is implanted.The following things may cause implants to deflate: damage by surgical instruments; folding or wrinkling of the implant shell; excessive force to the chest (e.G., during closed capsulotomy, which is contraindicated); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.Laboratory studies have identified some of the causes of deflation for allergan¿s product; however, it is not conclusively known whether these tests have identified all causes of deflation.
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