Allergan wins FDA nod for Natrelle Inspira breast implants

Allergan (NYSE: AGN) said last week that it won FDA pre-market approval for its Natrelle Inspira cohesive breast implants for women undergoing breast reconstruction, augmentation or revision surgery. The newly cleared Natrelle Inspira implants combine both a high gel fill ratio and the company’s cohesive gel to create a customized shape, the company said. “Natrelle Inspira cohesive breast implants are just the latest example of our commitment to innovation in breast aesthetics and plastic surgery, and we are proud that we are able to continue to offer advancements in technology that allow physicians and their patients more options. Natrelle Inspira cohesive allows patients to get the same high gel fill ratio and fullness offered by the Natrelle Inspira line of implants, with our highly cohesive, form-stable gel,” chief R&D officer David Nicholson said in a press release. “I make it my personal mission to give my patients the best possible cosmetic results after breast reconstruction. I’ve been waiting for a form stable, cohesive round implant. I’ve been waiting for Natrelle Inspira Cohesive,” Dr. Lisa Cassileth of Cassileth Plastic Surgery said in a prepared statement. In Nov. 2014, Allergan said the FDA approved 2 new styles of its Natrelle 410 silicone-filled breast implants, the Natrelle X and L. The implants were approved for use in women undergoing breast augmentation, reconstruction or revision surg...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Allergan Inc. Source Type: news

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Allergan Plc said on Tuesday it will voluntarily recall and stop the sale of its Biocell textured breast implants in Canada after the country's health agency suspended the company's licenses for the implants, citing increased risk of cancer.
Source: Reuters: Health - Category: Consumer Health News Tags: healthNews Source Type: news
Many other countries have already banned the products. But the U.S. agency said the risk was still low, despite repeated requests from women and doctors that the implants be removed from the market.
Source: NYT - Category: American Health Authors: Tags: Breasts Implants Recalls and Bans of Products Food and Drug Administration Plastic Surgery Non-Hodgkin ' s Lymphoma Allergan Inc your-feed-science your-feed-healthcare Source Type: news
Conclusions: The number of confirmed cases of BIA-ALCL in Australia and New Zealand continues to rise. The implant-specific risk has now changed to reflect a strong link to implant surface area/roughness as a major association with this cancer.
Source: Plastic and Reconstructive Surgery - Category: Cosmetic Surgery Tags: Breast: Original Articles Source Type: research
France has banned several types of textured breast implants that have been linked to a rare form of cancer, and more countries appear to be following suit, including Canada and the Netherlands. For years researchers have raised concern about the potential association between breast implants and anaplastic large cell lymphoma (ALCL), a very rare form of cancer, but France is the first country to ban the devices. The ban took effect on Friday and covers macro-textured implants and implants with a polyurethane coating. The National Agency for Safety of Medicines and Health Products (ANSM) in France notified manufa...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Regulatory and Compliance Source Type: news
Health Canada said on Thursday it was advising Allergan Plc of the regulator's plans to suspend the license for the Botox-maker's Biocell breast implants, after a review regarding the risk of a rare cancer linked to breast implants.Reuters Health Information
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Health Canada said yesterday that it plans to suspend Allergan‘s (NYSE: AGN) licenses to sell its Biocell breast implants in the region due to a possible association with a rare immune system-cancer. The move follows the agency’s completion of a scientific assessment of macro-textured implants, which it said is part of a larger safety review of breast implants and their association with breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma. Health Canada said it launched the review last November due to an increase in Canadian and international cases of B...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Cosmetic/Aesthetic Regulatory/Compliance Women's Health Allergan Source Type: news
The ban covers textured breast implants, which are suspected of being linked to anaplastic large-cell lymphoma. Regulators in other countries are following suit.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Implants Breasts Plastic Surgery Accidents and Safety Allergan Inc France anaplastic large-cell lymphoma Source Type: news
FDA busted two manufacturers of silicone gel-filled breast implants this week for failure to comply with post-approval study requirements. The agency sent warning letters to Irvine, CA-based Mentor Worldwide, a unit of Johnson &Johnson, and to Santa Barbara, CA-based Sientra for deficiencies in each company's post-approval study for silicone breast implant approvals. Breast implants have been a source of contention between patient advocacy groups, industry, and FDA for decades. Implants were banned from the U.S. market from 1992 to 2006, and the devices have been the cause of an over...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news
The Food and Drug Administration is taking another look at breast implants because of renewed safety concerns.
Source: NYT Health - Category: Consumer Health News Authors: Tags: your-feed-science Implants Breasts Medical Devices Breast Cancer Women and Girls Plastic Surgery Autoimmune Diseases Allergan Inc Food and Drug Administration Mentor Worldwide LLC Sientra Inc. Source Type: news
A fourth-quarter earnings miss and the uncertainty around an upcoming FDA advisory panel meeting on breast implants sent Sientra (NSDQ:SIEN) shares down precipitously today. The Santa Barbara, Calif.-based medical aesthetics company’s losses widened 38.1% to -$24.6 million, or 86¢ per share, on sales growth of 71.9% to $19.0 million for the three months ended Dec. 31, 2018, compared with Q4 2017. Analysts on Wall Street were looking for losses of -68¢. Full-year losses were up 29.0% to -$82.6 million, or -$3.25 per share, on sales growth of 86.4% to $68.1 million compared with the prior year, Sientra said. ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic MassDevice Earnings Roundup Wall Street Beat Women's Health Sientra Source Type: news
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