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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.
The company's devices, BioZorb Marker and BioZorb LP Marker, are implanted in soft tissue, including breast tissue, where the site needs to be marked for future procedures, such as radiation for ...
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.
(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 ...
In 1987, Goldrich, a cancer patient, had serious difficulties with her implants for reconstruction after bi-lateral mastectomy. She learned that the breast implants had never been approved by the U.S. Food and Drug Administration (FDA). She wrote an article on the subject, “Restoration Drama”, which was published in Ms. in June 1988.
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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).