SANTA BARBARA, Calif., July 06, 2022 (GLOBE NEWSWIRE) — Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) approved the Low Plus Profile Projection Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breast reconstruction. This product will be commercially available for board-certified and board-eligible plastic surgeons in the United States in late July 2022. More than 500,0001 women in the U.S. chose to have a breast augmentation or revision procedure last year and, according to recent statistics from the American Society for Aesthetic Plastic Surgery,…
Author: Press Release
July 21, 2022 – UPDATE: The FDA provided an update to this safety communication. Read “Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication” for the latest information. Date Issued: June 2, 2022 The U.S. Food and Drug Administration (FDA) is updating our safety communication issued in March 2022 to inform consumers and health care providers about a new handpiece for the Apyx Renuvion/J-Plasma device system that can be used for certain aesthetic skin procedures. On May 25, 2022, the FDA cleared the Renuvion Dermal Handpiece to be used with the Apyx Medical Helium Plasma Generator for the treatment of moderate to severe…
Garden Grove, Calif., April 25, 2022–(PRNewswire) The Aesthetic Surgery Education and Research Foundation (ASERF) announced the election of Bruce Van Natta, MD, a plastic surgeon practicing in Indianapolis, IN as its new President. Dr. Van Natta is an aesthetic plastic surgeon certified by the American Board of Plastic Surgery. ASERF is the philanthropic research and education arm of The Aesthetic Society. As President of ASERF, Dr. Van Natta plans to lead ASERF in its pursuit to advance aesthetic surgery through research and education. Board certified by the American Board of Plastic Surgery, Dr. Bruce Van Natta has been a practicing plastic surgeon in Indianapolis for over 33…
Ideal Implant Incorporated, the leader with structured saline breast implants, is introducing a refined Generation 2 implant to give women the natural feel they want. The Generation 2 structured saline implants are fabricated to extremely precise standards. Shells are made on an advanced state-of-the-art robotic machine for more uniform thicknesses, giving the Gen 2 IDEAL IMPLANT the same natural feel as silicone gel implants. In addition, there is no wrinkling or rippling when the implant is held upright, even at the minimum fill volume. The unique implant design combines a series of shells and two chambers that hold the saline…
The FDA has provided updates to this safety communication:July 21, 2022 – UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety CommunicationJune 2, 2022 – UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication Date Issued: March 14, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures. Specifically, the FDA is warning against the use for procedures intended to improve the appearance of the skin through dermal resurfacing (a procedure on the skin to…
Washington, DC, – February 10, 2022 – The American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS), the world’s largest association of facial plastic surgeons, today released its 2021 member survey outcomes. Despite lingering pandemic concerns, 2021 saw catapulting demand for facial plastic surgery and aesthetic procedures as in-person events and face-to-face socialization resumed. After almost two years of canceled plans, minimal makeup and over analyzing their reflections on ZOOM, men and women are ready to regain confidence and shake off the sense of languishing dread that has dominated the collective consciousness throughout the pandemic. This sentiment is apparent in the newly…
PALM BEACH, Fla., Jan. 20, 2022 /PRNewswire/ — In 2017 Viper Equity Partners saw plastic surgery as the next big private equity target. They began signing up marquee offices nation wide and courting buyers to pay attention. Since then, they have closed 200m in transactions which they consider to be only the beginning of a 10-year run. “The first couple years were tough trying to gain interest from our PE partners,” stated David C. Branch, Viper’s founder. “We knew it would be huge once it started but, in those days, it was deal by deal,” stated Branch. Fast forward to 2022, the market is extremely…
Washington, D.C., October 27, 2021—(FDA) Today, the U.S. Food and Drug Administration took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. First, the agency issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. Additionally, the agency has approved new labeling for all legally marketed breast implants that includes a boxed warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device…
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 and health care professionals about the risks of breast implants. The draft guidance of this document was issued in 2019. “As new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,” said Binita Ashar, M.D., Director of the Office of Surgical and…
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 referred to by patients as breast implant illness (BII), which some patients report after receiving breast implants. The FDA is also qualifying the BREAST-Q Reconstruction Module as a medical device development tool (MDDT) to aid in the assessment of certain medical devices such as breast implants. Qualification of the BREAST-Q Reconstruction Module MDDT included the Physical Well-being (Chest), Psychosocial Well-being,…
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. The suit alleges multiple charges against Dr. Simon Ourian including among them Defamation and Slander, Libel, and Fraud. The case is filed in US District Court for the Southern District of Florida (case #1:2020cv21948) and is being handled by The Ferrarro Law Firm (“Ferraro Law”) in Miami, Florida with the legal team of James L. Ferraro, Esq and Janpaul Portal…
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 quality system and medical device reporting regulations Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with various regulatory requirements. The agency issued a warning letter to breast implant manufacturer Allergan of Irvine, California, for failing to comply with requirements—under two separate premarket approval orders—to conduct post-approval studies to assess the long-term…
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 Drug Administration is taking another significant step in protecting women’s health by helping to ensure patients have complete information about the benefits and risks of breast implants. In a draft guidance issued today, we are providing proposed labeling recommendations to manufacturers of these devices to help ensure women receive and understand information regarding the benefits and risks of breast implants. The draft…
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 “Six-year results from 438 women show that the structured breast implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation . . . . It combines certain key features and benefits of unstructured saline and silicone gel implants. The filler is only saline, which women like for peace of mind in…
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 TGA undertakes its role in balancing patient safety with the availability of medical devices for patients very seriously. The TGA has decided to take regulatory action on all breast implant and breast tissue expanders currently included in the Australian Register of Therapeutic Goods (ARTG). Eight models of breast implants are to be suspended from supply in Australia for six months,…
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 that new lipstick shade before you buy it while in the comfort of your own home? These apps and filters are all the rage and for some users, they can be fun, fulfilling and even help them to visualize a potential new look and express their desires to a board-certified facial plastic surgeon during a consultation. But there may be…
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 specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly…
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 CanadaIssue: Important Safety InformationAudience: General Public, Healthcare ProfessionalsIdentification number: RA-70045 Last updated: 2019-05-28 Media enquiriesPublic enquiries OTTAWA – Health Canada has completed an update to a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and has found that the rate of BIA-ALCL in Canada is significantly higher in patients with macro-textured breast implants compared to other implants. As a result,…
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 surgeon certified by the American Board of Plastic Surgery. ASERF is the philanthropic research and education arm of the American Society for Aesthetic Plastic Surgery (The Aesthetic Society). As President of ASERF, Dr. Whitfield plans to continue work on initiatives including extensive research pertaining to Breast Implant Illness (BII) and other breast implant-related issues, following The Aesthetic Society’s and ASERF’s recent successes…
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 issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease. Since that time, we have worked diligently to fill the gaps in…
Washington, D.C., March 19, 2019—(FDA) Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants. The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term…
Washington, D.C., February 14, 2019—(FDA) FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants Today, the U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue. The warning letter also notifies Dr. Berman of significant deviations from the FDA’s quality system requirements and current good manufacturing practices (CGMPs),…
London, England, 04 October 2018 (Last updated: 27 Mar 2019 13:37)—British Association of Aesthetic Plastic Sugeons (BAAPS) THE BOTTOM LINE Popularity of Risky Buttock Enhancement Procedures Leading to Costliest Emergency Complications — British Surgeons Warned Not to Perform Procedure until More Data is Collected — Eye-Watering Costs to Health Service — Psychological Screening as Crucial as Medical History London – 4 October, 2018 – As many as four out of five[1] plastic surgeons in recent years have noted a wild increase in patients requiring revision after botched cosmetic surgery abroad – but today, NEW research unveiled at the Annual Scientific Meeting of the British…
Washington, D.C., November 13, 2017—(FDA) The U.S. Food and Drug Administration today issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement that can result from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts and other body parts. “An important part of our public health mission is our obligation to warn consumers of unapproved products that are being marketed for medical uses that can cause serious harm. We have significant concerns with unsafe injectable silicone that’s being marketed…
ORLANDO, Fla., Oct. 6, 2017 /PRNewswire/ — Ideal Implant Incorporated today announced that new 6-year clinical trial data on the IDEAL IMPLANT® Structured Breast Implant will be included in two presentations at Plastic Surgery: The Meeting, the upcoming annual meeting of the American Society of Plastic Surgeons (ASPS). Presentation Title: “6-Year Clinical Trial Results with the Structured Breast Implant”Presenter: Gregg Anigian, MDDate: Sunday, October 8, 2017Time: 4:20 PMLocation: Orange County Convention Center, S320 EF Presentation Title: “Choosing the Right Breast Implant Technology” Presenter: Robert S Hamas, MDDate: Sunday, October 8, 2017Time: 5:00 PMLocation: Orange County Convention Center, S310 A-D IDEAL IMPLANT’s six-year clinical trial data will be presented by Gregg Anigian, MD, a board-certified plastic surgeon with a…