Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 09 March 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) approved Sientra, Inc.'s breast implant product on 9 March, making Sientra the third approved marketer for breast implant products in the US.
The approval comes amidst a world-wide scandal about breast augmentation products manufactured by French company Poly Implant Prothese (PIP), which has been under fire for manufacturing implants using industrial grade silicone. PIP's products have also been the subject of concerns of abnormally high rupture rates.
FDA noted that, "[a]s a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes."
In addition to other post-approval conditions, Sientra will:
FDA approves new silicone gel-filled breast implant
Regulatory Focus - French Breast Implant Scandal May Alter US Medical Device Regulation Debate
Tags: SIentra, Breast Augmentation, Cosmetic, Breast Implant, Implant, PIP, Latest News