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 application via qualtrics survey software.
The doctor indicated that in her experience using the product, 5-10% of the cases/patients have experienced post-operative development of seroma, 1-5% of the cases/patients have experienced capsular contraction, and 1-5% have experienced adhesions.
To date, no additional information has been provided.
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