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Catalog Number UNK STRATTICE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Capsular Contracture (1761)
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Event Type
Injury
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Manufacturer Narrative
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Conclusion: based on limited information, including no identification of the relevant lot number, a relationship between the event and strattice could not be determined.Due to lack of information, strattice as a contributing factor cannot be ruled out.Lifecell reports the event in an abundance of caution.Multiple attempts to obtain additional information are being made, including identification of the lot number.Should additional information be reported, a follow up adverse event report will be submitted; otherwise this investigation is concluded.
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Event Description
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On (b)(6) 2016, the patient underwent revision of her cosmetic augmentation that involved capsulectomies and implant exchanges due to bilateral capsular contracture with a baker grade of iv.Strattice was placed at that time.On (b)(6) 2016, the patient presented with possible calcification of her right breast.On (b)(6) 2018, the patient underwent revision of her right breast augmentation.Intraoperatively, the surgeon noted that the medial and central component of the mesh had incorporated, but the lateral component had become "fibrosed and shriveled." the surgeon removed the lateral component of the strattice mesh.The strattice lot numbers were not reported.
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Search Alerts/Recalls
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