#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA's Center for Devices and Radiological Health on the agency ’ s continuing efforts to educate patients on known risk of lymphoma from breast implants: https://go.usa.gov/xERN3   #MedicalDevice #FDA

#ICYMI: Read the statement from Binita Ashar, M.D., of @US_FDA 's Center for Devices and Radiological Health on the agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants: https://go.usa.gov/xERN3  #MedicalDevice #FDA
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Devices Authors: Source Type: news

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U.S. Food and Drug Administration takes another look at breast implants because of renewed safety concerns over a type of lymphoma.
Source: CBC | Health - Category: Consumer Health News Tags: News/Health 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
In a recentletter, the FDA encouraged health care professionals to learn more about the association between all breast implants —regardless of filling or texture—and anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin lymphoma.
Source: JAMA - Category: General Medicine Source Type: research
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
On Feb. 6, the FDA issued an update on the number of cases of breast implant-associated anaplastic large cell lymphoma, reporting that as of Sept. 30, 2018, the agency had received a total of 660 global reports regarding cases since 2010.
Source: AAFP News - Category: Primary Care Source Type: news
The FDS has warned pharmaceutical companies in the past about their use of paid surrogates on social media sites like Instagram to promote their products (see:Pharmaceutical Companies Continue to Experiment with Social Media;FDA Issues Warning Letter to Drug Company about Use of Instagram;GlaxoSmithKline Mines Social Media for Information about Adverse Drug Events). This issue has recently returned to the news (see:The latest Instagram influencer frontier? Medical promotions. Big pharma is partnering with influencers to sell new drugs and medical devices). Below is an excerpt from the article. It's long and provides ma...
Source: Lab Soft News - Category: Laboratory Medicine Authors: Source Type: blogs
Health Canada is reopening its safety review of breast implants after more Canadian women were identified with symptoms of a rare cancer. The department has received reports of 22 confirmed cases and another 22 suspected cases of breast implant-associated anaplastic large cell lymphoma.
Source: CBC | Health - Category: Consumer Health News Tags: News/Health Source Type: news
Health Canada is re-opening its safety review of breast implants after more Canadian women were identified with symptoms of a rare cancer. The department has received reports of 22 confirmed cases and another 22 suspected cases of breast implant-associated anaplastic large cell lymphoma.
Source: CBC | Health - Category: Consumer Health News Tags: News/Health Source Type: news
(WASHINGTON) — U.S. health officials say doctors should be on the lookout for a rare cancer linked to breast implants after receiving more reports of the disease. The Food and Drug Administration sent a letter late Wednesday to family doctors, nurses and other health professionals warning about the form of lymphoma in breast implant patients. In suspected cases, the FDA recommends laboratory testing to confirm or rule out of the disease. It’s the first time regulators have issued such a warning to doctors other than plastic surgeons. The disease is not breast cancer, but usually forms in the scar tissue that fo...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Cancer onetime Source Type: news
FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma and a known risk from breast implants, in 2011. The new total of reports is larger than the number of unique cases because patients, providers, and manufacturers may all repo...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Featured Food & Drug Administration (FDA) Implants News Well Oncology Women's Health Allergan Center for Devices and Radiological Health (CDRH) Source Type: news
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