Sientra silicone breast implant approved by FDA conditional on after-approval studies for 10 years
  • Blog Home
  • Uncategorized
  • Sientra silicone breast implant approved by FDA conditional on after-approval studies for 10 years

Silicone breast implants are used in women requiring breast tissue reconstruction at any age and also for increasing breast size (augmentation) for women over 22. 

Today the FDA took a novel step. It approved the new Sientra silicone gel-filled breast implant (technically a medical device), BUT required:

1) the company to continue to follow the 1,788 women originally receiving the implant FOR ANOTHER 7 years (they had already been studied for 3 years)...AND

2) required the company to start a 10-year, 4,782 woman study made up of women who get the Sientra silicone gel-filled implant to collect information on possible long-term complications such as lung cancer, breast cancer, rheumatoid arthritis and capsular contracture...AND

3) is requiring the company to conduct five case-control results (outcomes) studies that are going to evaluate the association between Sientra's silicone gel-filled breast implants and five rare disease which include: lymphoma, cervical/vulvular cancer, brain cancer, neurological disease and rare connective tissue tisease.

The FDA noted in its press release (visit www.fda.gov) that the design of the post-approval studies will require Sientra to collect valuable safety information...

Having written all of this, this editor has never seen such a requirement from the FDA. this appears to mark a new and amazing approach for this maker of breast implants who now joins Allergan and Mentor in this field. While this is a lot to undertake for the company, their product may become the one with the most safety information and while it has become the third one to be approved, it could become the most trusted implant based on possible positive results from these ongoing studies. 

Comments: