FAQs: PIP Breast Implants – Breast Augmentation

PIP Breast Implants

PIP implants are not currently approved by the FDA to be marketed in the U.S.

PIP implants are breast implants manufactured in the south of France by Poly Implant Prostheses, and, until recently, imported by PIP/USA. PIP implants are saline but, unlike other saline implants, they are pre-filled.

The FDA required all implant manufacturers to submit a Pre-Market Approval application in order to make a determination as to what implants were proven safe and effective for continued sale. The FDA Panel did not recommend approval of PIP implants due to the fact that the clinical study submitted by PIP did not have a sufficient number of patients with 2 years post-surgery. As a result, PIP stopped selling its implants in the U.S. on May 15, 2000.

PIP has applied to the FDA for approval to use PIP implants for deflations, complications such as infection and capsular contracture requiring a second surgery. PIP has also requested the FDA's approval for PIP to conduct a trial which would allow surgeons to use the implants as part of a study.