Search results
Results from the WOW.Com Content Network
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.
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.
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 ...
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.
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
(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 ...
It is a medical complication that can be painful and discomforting, and might distort the aesthetics of the breast implant and the breast. Although the cause of capsular contracture is unknown, factors common to its incidence include bacterial contamination, rupture of the breast-implant shell, leakage of the silicone-gel filling, and hematoma.