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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.
Women who have the recalled implants, which have been linked to a cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) are facing a tough decision of what to do next.
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.
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).
Polypropylene implants absorb water very slowly, about <0.01% in 24 hours. [2] The polypropylene, which is yarn-like, causes irritation to the implant pocket which causes the production of serum which fills the implant pocket on a continual basis. [citation needed] This causes continuous expansion of the breast after surgery. Growth can only be ...
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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 ...