Washington, D.C., September 28, 2020—(FDA) Today, the U.S. Food and Drug Administration issued the final guidance, “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication,” as part of the agency’s effort to help improve the information available to patients…
News Releases
Washington, D.C., May 14, 2020—(FDA) Today, the U.S. Food and Drug Administration is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms…
Miami, Florida, (PRWEB)—May 20, 2020 Award winning and highly renowned, board certified Miami based plastic surgeon, Dr. Adam J. Rubinstein, M.D. FACS has filed a multimillion dollar lawsuit against Dr. Simon Ourian M.D. and Epione Medical Corporation in Beverly Hills.…
Washington, D.C., May 14, 2020—(FDA) FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients Allergan cited for failure to comply with post-approval study requirements; Ideal Implant Inc. cited for failures relating to…
Washington, D.C., October 23, 2019—(FDA) For Immediate Release:October 23, 2019 Statement From:Amy Abernethy, MD, PhD.; Principal Deputy Commissioner – Office of the CommissionerJeffrey E. Shuren, MD, JD; Director – CDRH Offices: Office of the Center Director The U.S. Food and…
A clinical article reviewing the long-term performance of the latest structured breast implant technology received the 2019 PRS Best Cosmetic Surgery Paper Award at Plastic Surgery – The Meeting 2019 in San Diego last month. The winning article concludes that…
The Therapeutic Goods Administration (TGA) has today released the findings of its review into breast implants and breast tissue expanders following reports of around 100 cases of Breast Implant Associated Anaplastic Large Cell Lymphoma in Australia, including four deaths. The…
Washington, DC, September 11, 2019 — (AAFRPS) Virtual reality makeover apps and photo filters can be loads of fun. Who wouldn’t want to see what they may look like with a smaller nose, fuller lips or a blemish-free complexion? Why not try on…
Washington, D.C., July 24, 2019—(FDA) The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall…
Ottawa, May 28, 2019–(Health Canada) Information update Health Canada suspends Allergan’s licences for its Biocell breast implants after safety review concludes an increased risk of cancer Starting date: May 28, 2019Type of communication: Information UpdateSubcategory: Medical DeviceSource of recall: Health…
NEW ORLEANS, May 19, 2019 / PRNewswire / — The Aesthetic Surgery Education and Research Foundation (ASERF) announced the election of Robert Whitfield, MD, a plastic surgeon practicing in West Lake Hills, Texas as its new President. Dr. Whitfield is an aesthetic and reconstructive plastic…
Washington, D.C., May 02, 2019—(FDA) There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an…