FDA approves new silicone gel-filled breast implant Approval conditioned on post-approval safety studies
Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
As 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.
Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle ...
Whitney Houston reportedly went to a plastic surgeon for a face lift several weeks before her death. She was denied the surgery because she apparently failed the medical clearance. The exact reason she was not found to be a candidate for the surgery is not known at this time. However, this story underlines the extreme importance of a medical history and examination prior to surgery. This examination is often performed by the plastic surgeon during the consultation and additional medical work- up and testing as found to be necessary by the consulting surgeon. Unfortunately this medical evaluation did not help ...
By Alexandria Sage, Natalie Huet and Jean-Francois Rosnoblet
MARSEILLE, France (Reuters) Feb 02 - In March 2010, a pair of health inspectors acting on a tip paid a three-day visit to a factory in this hilly town on the Mediterranean coast.
The factory was the headquarters of Poly Implant Prothese (PIP), a leading international maker of breast implants founded by French entrepreneur Jean-Claude Mas. The inspectors found something odd: six discarded plastic containers of Silopren, a liquid silicone designed for industrial, not medical use, lined up along the outside wall of the production site.
MARSEILLE, France (Reuters) Jan 26 - Jean-Claude Mas, the Frenchman who has sparked a global health scare by selling substandard breast implants, was arrested on Thursday and could be charged with manslaughter, the public prosecutor in the city of Marseille said.
In the first arrests since the two-year-old scandal grabbed headlines worldwide in December, Mas and a second executive at his now defunct company Poly Implant Prothese (PIP) were seized at their homes in southern France shortly after dawn.
If charged with involuntary manslaughter and causing injury, both could face longer prison terms than those they already ...
Attached is the PIP breast implant video clip - run on Univision news. I discuss the problems that have become apparent with these French made silicone breast implants. The implants may have been produced and distributed throughout the world over the past 20 years to as many as 400,000 patients. The PIP silicone implants were never sold in the United States. However, there are many women living in the United States who had their surgery in South or Central America or Europe that may be affected. The clip also features a patient of mine who underwent a surgical procedure three ...
There are many breast augmentation patients that are quite concerned about PIP implants. Unfortunately there may be several hundred thousand patients worldwide that may be affected by these improperly made implants from France. Luckily for patients that have had their surgery performed by Board Certified Plastic Surgeons in the United States, this is not a concern as the only breast implant companies approved for use in the U.S. are Mentor and Allergan, both of which are FDA approved, safe, and made to the highest standards possible. However, there are many patients in the U.S. that have had their ...
