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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.
The FDA approved a design change for the company's Opus breast implants. Skip to main content. 24/7 Help. For premium support please call: 800-290-4726 more ways to reach us. Sign in ...
Mentor Corporation was founded in Minneapolis, Minnesota in 1969 by Christopher Conway, Eugene Glover, and Thomas Hauser. [5] [6] Mentor went public in 1970 and its first product line consisted of electronic laboratory instruments for the detection and measurement of the electrical activity of nerve cells and neural systems.
By Alan Hatfield Sientra, Inc. (Nasdaq: SIEN) is a medical aesthetics company focused on enhancing lives by advancing the art of plastic surgery. IPO Edge sat down with Sientra […]
Throughout the 1980s and 1990s, class-action lawsuits [12] brought by tens of thousands of plaintiffs claimed that Dow Corning's silicone breast implants caused systemic health problems. The claims first centered on breast cancer and then migrated to a range of autoimmune diseases, including lupus, rheumatoid arthritis and various neurological ...
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).
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.