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The U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson & Johnson unit for failing to comply with the post-approval study requirements for their breast implants.
It produces one of two silicone gel breast implants. Titled MemoryGel, the product was approved by the U.S. Food and Drug Administration (FDA) on November 17, 2006. The other FDA-approved products are developed by competitors Allergan and Sientra.
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The Mentor Worldwide LLC corporation, one of the three, U.S. FDA-approved breast-implant device manufacturers, conducted a study of the medical complications suffered by breast implantation surgery patients. In March 2000, at a Food and Drug Administration presentation, the Mentor report indicated that 43 per cent of patients with saline breast ...
(Reuters) -The U.S. Food and Drug Administration on Wednesday classified a recall of Hologic's devices that are implanted in soft tissue such as breast tissue as "most serious", and urged doctors ...
A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast.In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery.
Poly Implant Prothèse (PIP) was a French company founded in 1991 that produced silicone gel breast implants.The company was preemptively liquidated in 2010 following the revelation that they had been illegally manufacturing and selling breast implants made from cheaper industrial-grade silicone since 2001 (instead of the mandated medical-grade silicone they had previously used).
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