Breast Reconstruction - FDA Warning About Strattice

asked 11 months ago by ConcernedChicagoHusband in Chicago, IL
Latest answer by Steven Wallach, MD
Question viewed 452 times
Tags: FDA, strattice

My wife will be under going a mastectomy. She was told that they could use alloderm or strattice in conjunction with her tissue expanders. So I started to research. In May the FDA just recently warned that Strattice was not cleared or approved for the use in breast reconstruction and the company's marketing campaign on the website regarding Strattice and breast reconstruction was taken down. I am concerned about my wife and what is best for her. Is alloderm now considered the safer way to go?

3 answers to Breast Reconstruction - FDA Warning About Strattice

Breast reconstruction and strattice

Strattice has been approved for post-cosmetic breast recosntruction, whereas Alloderm has been approved for breast reconstruction from cancer. Both really do the same thing.

Steven Wallach, MD
Manhattan Plastic Surgeon

Strattice and Alloderm are both acceptable with implant surgery

Alloderm and Strattice are both what are called an "acellular dermal matrix" and they support the growth of your own tissue to make a sort of internal living bra. The FDA's guidance relates to product labeling which we might see as more of a technical issue than a practical one. Alloderm is cleared for marketing as a reconstructive material, while Strattice is cleared to market for revisions of cosmetic augmentation; however, in both instances it is implanted to support a... more

Richard Baxter, MD
Seattle Plastic Surgeon