Today, the @US_FDA issued a warning letter citing safety concerns regarding an illegally marketed device that claims to prevent and treat tightening of scar tissue around breast implants. Read the more about the warning letter here: https://go.usa.gov/xEUks  
Today, the @US_FDA issued a warning letter citing safety concerns regarding an illegally marketed device that claims to prevent and treat tightening of scar tissue around breast implants. Read the more about the warning letter here: https://go.usa.gov/xEUks  (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 14, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants
(Source: Food and Drug Administration)
Source: Food and Drug Administration - February 14, 2019 Category: American Health Source Type: news

Book Review: Eating Disorders: The Journey to Recovery Workbook, 2nd Ed.
There is no such thing as a life free of distress. And yet in the distress — by learning to move through it, find strengths that help us cope, and most importantly, not avoid it — we often find the path to growth. This path, from finding escape from the distress of life to finding growth in it, is also the journey that underlies the recovery from an eating disorder. “People with eating disorders, like all people, flourish when they feel a sense of agency,” write authors Laura J. Goodman and Mona Villapiano. In their new book, Eating Disorders: The Journey to Recovery Workbook, 2nd Ed., Laura J. Good...
Source: Psych Central - February 13, 2019 Category: Psychiatry Authors: Claire Nana Tags: Addictions Anorexia Binge Eating Book Reviews Bulimia Diet & Nutrition Disorders Eating Disorders General Habits Healthy Living Psychology Self-Esteem Self-Help Trauma Treatment Weight Loss books on how to recover from an Source Type: news

Safety review of breast implants re-opened after Implant Files stories
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)
Source: CBC | Health - February 12, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

Safety review of breast implants reopened after Implant Files stories
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)
Source: CBC | Health - February 12, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

Woman left with 'bubble boobs' after the plastic surgery she spent her life savings on went wrong 
Jacqueline Harvey, 23, from Brisbane, spent five years saving for breast augmentation but immediately regretted her decision when she looked in the mirror, last year. (Source: the Mail online | Health)
Source: the Mail online | Health - February 12, 2019 Category: Consumer Health News Source Type: news

#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)
Source: Food and Drug Adminstration (FDA): CDRHNew - February 8, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA warns more doctors of rare cancer with breast implants
U.S. health officials are telling doctors to be on the lookout for a rare cancer linked to breast implants. (Source: CBC | Health)
Source: CBC | Health - February 8, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

New Cases of Cancer Linked to Breast Implants Surface
Title: New Cases of Cancer Linked to Breast Implants SurfaceCategory: Health NewsCreated: 2/7/2019 12:00:00 AMLast Editorial Review: 2/8/2019 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - February 8, 2019 Category: Cancer & Oncology Source Type: news

FDA: Number of U.S. Women With Breast Implant-Caused Cancer Has Increased
THURSDAY, Feb. 7, 2019 -- There has been an increase in the number of U.S. women diagnosed with a cancer caused by breast implants, the U.S. Food and Drug Administration said Wednesday. The number of women with breast implant-associated anaplastic... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 7, 2019 Category: Pharmaceuticals Source Type: news

FDA Warns Doctors to Look Out for Rare Cancer Linked to Breast Implants
(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 - February 7, 2019 Category: Consumer Health News Authors: MATTHEW PERRONE / AP Tags: Uncategorized Cancer onetime Source Type: news

Number of cancer cases linked to breast implants soars
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 - February 7, 2019 Category: Medical Devices Authors: Nancy Crotti 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

FDA alerts more doctors of rare cancer with breast implants
FDA tells more doctors to watch for rare cancer linked to breast implants (Source: ABC News: Health)
Source: ABC News: Health - February 7, 2019 Category: Consumer Health News Tags: Health Source Type: news

Breast implants linked to lymphoma, FDA says
Breast implants are causing more deadly breast cancer among women, according to the U.S. Food and Drug Administration. (Source: Health News - UPI.com)
Source: Health News - UPI.com - February 7, 2019 Category: Consumer Health News Source Type: news

Cancer Linked to Surface of Breast Implants
The number of women with breast implant-associated anaplastic large cell lyphoma (BIA-ALCL) now stands at 457, compared with 414 in the last report, the FDA says. (Source: WebMD Health)
Source: WebMD Health - February 7, 2019 Category: Consumer Health News Source Type: news

FDA reports additional cases of cancer linked to breast implants
A rare and deadly cancer linked to breast implants has been diagnosed in additional women in the United States, federal health officials said. (Source: CNN.com - Health)
Source: CNN.com - Health - February 7, 2019 Category: Consumer Health News Source Type: news

WATCH: FDA issues new warnings on breast implants
ABC News Chief Medical Correspondent Dr. Jennifer Ashton shares what women should know about the symptoms for which they need to look. (Source: ABC News: Health)
Source: ABC News: Health - February 7, 2019 Category: Consumer Health News Tags: GMA Source Type: news

Health Highlights: Feb. 7, 2019
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: New Cases of Cancer Linked to Breast Implants Surface There's been an increase in the number of U.S. women diagnosed with a deadly cancer caused... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 7, 2019 Category: General Medicine Source Type: news

Statement from Binita Ashar, M.D., of the FDA ’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants
Statement from Binita Ashar, M.D., of the FDA ’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 6, 2019 Category: American Health Source Type: news

Statement from Binita Ashar, M.D., of the FDA ’ s Center for Devices and Radiological Health on agency ’ s continuing efforts to educate patients on known risk of lymphoma from breast implants
Statement from Binita Ashar, M.D., of the FDA ’ s Center for Devices and Radiological Health on agency ’ s continuing efforts to educate patients on known risk of lymphoma from breast implants (Source: Food and Drug Administration)
Source: Food and Drug Administration - February 6, 2019 Category: American Health Source Type: news

FDA updates adverse event report for NY mammo facility
The U.S. Food and Drug Administration (FDA) has updated an adverse event report...Read more on AuntMinnie.comRelated Reading: FDA posts final guidance for new 510(k) pathway FDA files action against Nev. imaging center for mammography FDA posts alert for NC mammography facility FDA issues update on cancer linked to breast implants FDA issues adverse MQSA report for ND hospital (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 5, 2019 Category: Radiology Source Type: news

FDA sets date for advisory panel meeting on breast implants
The FDA announced today that it tentatively plans to hold a meeting of the General and Plastic Surgery Devices Panel, March 25-26. The meeting will take place at the FDA’s headquarters in Silver Spring, Md. The meeting will discuss a range of topics concerning benefit-risk profiles of breast implants, according to the FDA. Breast implants are considered implantable medical devices. They are implanted under the breast tissue or under the chest muscle for augmentation or reconstructive surgery. They can also be used in revision surgeries. Two types of breast implants are currently approved for sale in the U.S.. Th...
Source: Mass Device - January 30, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Food & Drug Administration (FDA) breast implants Source Type: news

6 medical device news stories to watch in 2019
Sandra Maddock, president & CEO of IMARC Research With new technology and groundbreaking medical device news making headlines every day, there has never been a more exciting time to be involved in clinical research. So much is changing so fast — faster than at any other time in the history of clinical research. At IMARC Research, we take pride in innovation. We’re constantly monitoring medical device trends and regulatory updates to determine how they might apply to the clinical research teams who enlist our oversight. We know this will be a transformational year, so we’re excited to kick off 201...
Source: Mass Device - January 29, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

US FDA Breast Implant Postapproval Studies US FDA Breast Implant Postapproval Studies
What has long-term safety and efficacy data told us about the outcomes of patients with silicone breast implants?Annals of Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 29, 2019 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news

Former Mrs Virginia left suicidal and bed-ridden in agonizing pain by her BREAST IMPLANTS
Mother-of-three Brandi Pope, 38, of Virginia, had silicone implants in 2009 and saw her health decline. She had implants removed after a friend told her about 'breast implant illness'. (Source: the Mail online | Health)
Source: the Mail online | Health - January 17, 2019 Category: Consumer Health News Source Type: news

Former Miss Virginia left suicidal and bed-ridden in agonizing pain by her BREAST IMPLANTS
Mother-of-three Brandi Pope, 38, of Virginia, had silicone implants in 2009 and saw her health decline. She had implants removed after a friend told her about 'breast implant illness'. (Source: the Mail online | Health)
Source: the Mail online | Health - January 17, 2019 Category: Consumer Health News Source Type: news

UNDER THE MICROSCOPE:  TV presenter Anthea Turner, 58, answers our health quiz 
The ex-Blue Peter star has suffered lots of horse riding injuries, but is still perfectly fit and active - although she can't resist the lure of chips. She also had breast augmentation surgery in 2003. (Source: the Mail online | Health)
Source: the Mail online | Health - January 14, 2019 Category: Consumer Health News Source Type: news

Breast implants can cause cancer chronic fatigue arthritis and other side effects
Daisy Jones, a 29-year-old life coach from Leigh-on-Sea in Essex thinks the breast implants she had fitted at 19 have ruptured. (Source: the Mail online | Health)
Source: the Mail online | Health - January 1, 2019 Category: Consumer Health News Source Type: news

Allergan Stops Sales of Textured Breast Implants in Europe Allergan Stops Sales of Textured Breast Implants in Europe
Drugmaker Allergan said on Wednesday it would take its textured breast implants off the market in Europe, a day after a French regulatory body ordered the move because the implants have been linked to a rare form of cancer.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - December 21, 2018 Category: Surgery Tags: Family Medicine/Primary Care News Source Type: news

Breast implants withdrawn from sale in Europe
UK surgeons advised not to use Allergan textured implants Related items fromOnMedica PIP implants: Taking the right decision and lessons to be learnt NHS receives over 7,000 breast implant referrals Over a thousand women identified as having undergone FGM Midwife-led birth safest for straightforward pregnancy Eight in ten stillbirths might have been avoided (Source: OnMedica Latest News)
Source: OnMedica Latest News - December 20, 2018 Category: UK Health Source Type: news

Allergan stops sale of textured breast implants in Europe, shares sink
Drugmaker Allergan Plc said on Wednesday it would take its textured breast implants off the market in Europe, a day after a French regulatory body ordered a recall of the implants, which have been linked to a rare form of cancer. (Source: Reuters: Health)
Source: Reuters: Health - December 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Allergan pulls textured breast implants from the European market
Allergan (NYSE: AGN) has removed its textured breast implants from the market in Europe following a recall request from French regulators. France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee to discuss the matter in February next year. The New York Times reported this week that the implants were linked to an uncommon form of lymphoma that can arise years after the implant is placed. Allergan’s CE Mark in the E.U....
Source: Mass Device - December 19, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Implants Recalls Regulatory/Compliance Wall Street Beat Women's Health Allergan Source Type: news

Allergan stops sales of textured breast implants in Europe
Drugmaker Allergan said on Wednesday it would take its textured breast implants off the market in Europe, a day after a French regulatory body ordered the move because the implants have been linked to a rare form of cancer. (Source: Reuters: Health)
Source: Reuters: Health - December 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Authorities BAN popular textured breast implants from use in Europe
Allergan textured breast implants have had their safety approval suspended by French authorities at a time when there is growing concern about their ability to trigger a rare type of cancer. (Source: the Mail online | Health)
Source: the Mail online | Health - December 19, 2018 Category: Consumer Health News Source Type: news

Mother who baffled doctors with mystery rashes and blurry vision blames her ‘toxic breast implants’
Christina Roulund, from Palm City in Florida, claims the breast implants she had in 2006 caused her numerous health problems which couldn't be explained by doctors and is warning others. (Source: the Mail online | Health)
Source: the Mail online | Health - December 19, 2018 Category: Consumer Health News Source Type: news

Allergan stops sales in Europe of breast implants linked to cancer
Breast implants made by drugmaker Allergan, which have been linked to a rare form of cancer, are being taken off the market in Europe, said a French regulatory body. (Source: Reuters: Health)
Source: Reuters: Health - December 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Allergan Halts Sales in Europe of Textured Breast Implants Linked to Rare Cancer
The company ’ s product, in use worldwide, has been under scrutiny since women began developing a type of lymphoma. (Source: NYT Health)
Source: NYT Health - December 19, 2018 Category: Consumer Health News Authors: DENISE GRADY Tags: Implants Breasts Medical Devices Plastic Surgery Non-Hodgkin's Lymphoma France Allergan Inc Cancer Recalls and Bans of Products Europe Source Type: news

29-year-old fitness model develops 'breast implant illness' and has reversal surgery
Sia Cooper, 29, a fitness blogger from Florida got her 32DDD breast implants removed after experiencing nearly seven years of extreme fatigue, facial rashes, chest pain, brain fog and hair loss. (Source: the Mail online | Health)
Source: the Mail online | Health - December 18, 2018 Category: Consumer Health News Source Type: news

Mother, 34, who was 'slowly dying' removes 'toxic' breast implants after four years of agony  
Andrea King, of Chicago, was diagnosed with four diseases as her health declined after breast enlargement. Doctors even wondered if she had HIV before she decided to remove the implants. (Source: the Mail online | Health)
Source: the Mail online | Health - December 17, 2018 Category: Consumer Health News Source Type: news

'We can get you to the beach the next day': Breast implant marketing plays on insecurities, minimizes risks
Breast augmentation is the most popular cosmetic surgery in the world, with 10 million women opting for breast implants during the past decade. We took hidden cameras into the offices of three Toronto plastic surgeons to review how they explain and sell the procedure. (Source: CBC | Health)
Source: CBC | Health - November 30, 2018 Category: Consumer Health News Tags: News/Health Source Type: news

'It was made to seem like getting a haircut': Patient says breast implant sales pitch glossed over risks
Breast augmentation is the most popular cosmetic surgery in the world, with 10 million women opting for breast implants during the past decade. We took hidden cameras into the offices of three Toronto plastic surgeons to review how they explain and sell the procedure. (Source: CBC | Health)
Source: CBC | Health - November 30, 2018 Category: Consumer Health News Tags: News/Health Source Type: news

Research links rare cancer to breast implants, but Health Canada says no safety advisory is needed
At least 25 Canadian women have developed a rare cancer linked to breast implants — and almost all of them had the same type of textured implant, according to researchers. But Health Canada has no plans to remove this implant from the market or to directly alert Canadian women who have the implants, an investigation by Enquête and Radio-Canada has shown. (Source: CBC | Health)
Source: CBC | Health - November 29, 2018 Category: Consumer Health News Tags: News/Health Source Type: news

Rare cancer linked to breast implants, but Health Canada says no safety advisory is needed
At least 25 Canadian women have developed a rare cancer linked to breast implants — and almost all of them had the same type of textured implant, according to researchers. But Health Canada has no plans to remove this implant from the market or to directly alert Canadian women who have the implants, an investigation by Enquête and Radio-Canada has shown. (Source: CBC | Health)
Source: CBC | Health - November 29, 2018 Category: Consumer Health News Tags: News/Health Source Type: news

Report: FDA-reported breast implant injuries kept hidden by summary reporting
The number of medical device reports sent to the FDA concerning issues with breast implants was kept artificially low through the use of summary reporting, according to a new report from the Honolulu Star Advertiser. Between 2008 and 2015, the FDA received an average of approximately 200 medical device reports related to breast implants, significantly lower than the thousands the agency had come to expect prior to those dates, according to the report. The lowered number of reports was due to a change at the FDA which allowed manufacturers of such devices to report issues in bulk, meaning a single filed report with the FDA ...
Source: Mass Device - November 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Source Type: news

Breast implants reveal problems in tracking device safety
A new investigation shows that incomplete, underreported and unverified data make it nearly impossible for patients and doctors to know how safe medical devices are, especially when it comes to breast implants (Source: ABC News: Health)
Source: ABC News: Health - November 26, 2018 Category: Consumer Health News Tags: Health Source Type: news

Implants May Still Hinder FFDM with Tomosynthesis
(MedPage Today) -- Presence of breast implants tied to decreased recall rates and cancer detection rates (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - November 26, 2018 Category: Hematology Source Type: news

Breast implant injuries hidden as patients' questions mount
A new investigation shows that incomplete, underreported and unverified data make it nearly impossible for patients and doctors to know how safe medical devices are, especially when it comes to breast implants (Source: ABC News: Health)
Source: ABC News: Health - November 26, 2018 Category: Consumer Health News Tags: Health Source Type: news

Safety concerns raised over breast implants
Some makers of textured implants did not carry out adequate tests, an investigation finds. (Source: BBC News | Health | UK Edition)
Source: BBC News | Health | UK Edition - November 26, 2018 Category: Consumer Health News Source Type: news

Biocell textured breast implants under scrutiny as women complain of pain
Biocell textured breast implants, made by Allergan, have come under growing scrutiny from some doctors who say they are seeing many of their patients return with debilitating pain. (Source: CBC | Health)
Source: CBC | Health - November 26, 2018 Category: Consumer Health News Tags: News/Health Source Type: news

1,000 patients died in three years ‘after having faulty implants'
UK regulators were handed 62,000 ‘adverse incident’ reports between 2015 and 2018 linked to components such as pacemakers, artificial hips, breast implants and contraceptives. (Source: the Mail online | Health)
Source: the Mail online | Health - November 26, 2018 Category: Consumer Health News Source Type: news