What Do You Mean – I May Have Something in Me That Isn’t Supposed to Be There?
Yep. It’s unsettling, isn’t it? The Seri Surgical Scaffold was originally developed for use in plastic surgery to help the body recover. The idea was that the mesh would be made of silk so it would dissolve naturally in the body and never cause any harm to anyone. In fact, women may have been told that the product would dissolve within two years and their body would naturally create tissue to replace it. All natural. All safe. Totally easy, “miracle” solution.
At least, that seemed to be the idea on paper. In reality, the Scaffold was created from a bio-engineered silk, meaning that the mesh was artificially created and didn’t dissolve in the body like natural silk. On top of that, after receiving FDA approval, Allergen allegedly began marketing the Scaffold for procedures outside of the scope of that approval, as noted in the FDA warning letter.
The Scaffold was marketed for use in:
- Breast revision surgery
- Breast lift or Mastopexy
- Breast reductions
- Muscle flap reinforcement
And now women are getting infections so serious they had to go back to the hospital for “red breast” or other serious (as in, life-threatening/hospital-worthy) health problems.
FYI – In March 2016, a second letter from the FDA to Allergen showed that the company made changes necessary to address the violations in the 2015 warning letter.
