Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received a complaint on (b)(6) 2020.An adverse event was reported through a post market survey for tutomesh for breast reconstruction.The survey indicated that the dr.(b)(6) (5 years experience with the product; less than 10 cases/year), has experienced the following post-operative complications: red breast syndrome, seroma formation and slow resorption in less than 1% of cases.The physician indicated in the survey that the radiation induced fibrosis has improved due to the use of tutomesh.Additional information has been requested.To date, no additional information has been received.
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