A Boat Crushed His Face. Then Plastic Surgeons Hit Him With $167,000 in Medical Costs
Bob Ensor didn’t see the boom swinging violently toward him as he cleaned a sailboat in dry dock on a spring day two years ago. But he heard the crack as it hit him in the face. He was transported by ambulance to an in-network hospital near his home in Middletown, N.J., where initial X-rays showed his nose was broken as were several bones of his left eye socket. The emergency physician summoned the on-call plastic surgeon, who admitted him to the hospital and scheduled him for surgery the next day. Shortly before surgery, the doctor introduced Ensor to a second plastic surgeon who would assist in the 90-minute proced...
Source: TIME: Health - May 6, 2019 Category: Consumer Health News Authors: Michelle Andrews / Kaiser Health News Tags: Uncategorized Healthcare Source Type: news

FDA: No Ban for Textured Breast Implants
The agency said it's too soon to ban a type of textured implant recently linked to a rare form of lymphoma (Source: WebMD Health)
Source: WebMD Health - May 3, 2019 Category: Consumer Health News Source Type: news

FDA Allows Continued Sales of Textured Breast Implants FDA Allows Continued Sales of Textured Breast Implants
US regulators are considering additional steps, including adding a boxed warning, regarding risks of breast implants.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - May 3, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Breast implants tied to rare cancer to remain on market
The FDA says the risks do not warrant a national ban (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - May 3, 2019 Category: Consumer Health News Source Type: news

Breast Implants Linked to Cancer Can Still be Sold in U.S.: FDA
Title: Breast Implants Linked to Cancer Can Still be Sold in U.S.: FDACategory: Health NewsCreated: 5/3/2019 12:00:00 AMLast Editorial Review: 5/3/2019 12:00:00 AM (Source: MedicineNet Cancer General)
Source: MedicineNet Cancer General - May 3, 2019 Category: Cancer & Oncology Source Type: news

FDA Bans Summary Reporting for Breast Implants
FDA appears to be making good on its promise to make all adverse event reports public. The agency ended all summary reporting of breast implant medical device reports in an effort to promote greater transparency.  This is part of a larger effort to end the alternative summary reporting program for all medical devices, which FDA said it intends to complete in the coming weeks. The agency was accused earlier this year of hiding millions of adverse event reports from the public under what is known as the alternative summary reporting program, which was established in 1997. Making all of the data regarding adverse ...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

Breast implants tied to rare cancer to remain on US market
US will allow a type of breast implant linked to a rare form of cancer to stay on the market (Source: ABC News: Health)
Source: ABC News: Health - May 3, 2019 Category: Consumer Health News Tags: Health Source Type: news

Breast implants tied to cancer remain on U.S. market, under review by Health Canada
U.S. health authorities are allowing a type of breast implant with links to cancer to stay on the market. The same implant is under review by Health Canada. (Source: CBC | Health)
Source: CBC | Health - May 2, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

F.D.A. Won ’ t Ban Sales of Textured Breast Implants Linked to Cancer
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 Health)
Source: NYT Health - May 2, 2019 Category: Consumer Health News Authors: DENISE GRADY and RONI CARYN RABIN Tags: your-feed-science your-feed-healthcare Source Type: news

Today, the @US_FDA announced several new steps we have taken and are considering, aimed at helping to ensure that women have access to the information they need about breast implants. #MedicalDevice
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - May 2, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

FDA: Breast Implants Linked to Cancer Can Still Be Sold in U.S.
THURSDAY, May 2, 2019 -- A type of breast implant linked to cancer can still be sold in the United States, the U.S. Food and Drug Administration said Thursday. The agency said it is too soon to ban a type of textured implant recently linked to... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 2, 2019 Category: Pharmaceuticals Source Type: news

FDA won’t ban breast implants linked to cancer at this time
A month after a dramatic hearing in which many women called on the Food and Drug Administration to ban a type of breast implant linked to a rare cancer, the agency said it won’t take that action now b... (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - May 2, 2019 Category: Consumer Health News Authors: Laurie McGinley Source Type: news

Smooth or Textured: A Lesson in Biocompatibility
The objective of the textured surface is to limit movement and reduce the formation of overly tight scar tissue. It is noteworthy here that the function of the textured surface depends on its ability to alter tissue response. Yet this can lead to inconsistent thinking in which positive effects of surface changes are touted while negative effects are denied. Unfortunately, textured surfaces on breast implants have also been linked to the development of Anaplastic Large Cell Lymphoma (ALCL), an adverse effect beyond any associated just with the long-term presence of silicone. FDA has noted that factors influencing ALCL inclu...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: William A. Hyman Tags: Materials Source Type: news

Purified Fat Could Be an Alternative to Breast Implants
There has been intense discussion lately about the risks associated with breast implants. France has gone so far as to ban the use of textured breast implants – an act that occurred earlier this month. Solana Beach, CA-based Puregraft has developed an option other than an implant - a technology that would use a patient’s own fat, for breast augmentation, or restructuring. “Fat transfer, believe it or not, is the most popular procedure that you’ve never heard of,” Brad Conlan, Puregraft CEO, told MD+DI. “The first fat...
Source: MDDI - April 12, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Mother, 28, reveals she nearly died after TWO botched breast implants advertised on Instagram
Holly McCulloch, 28, of Greasby, Wirral, always felt down about her B-cup chest, particularly as she got older. She therefore booked herself into a clinic that charged £2,700 for a five-day, all-inclusive stay. (Source: the Mail online | Health)
Source: the Mail online | Health - April 11, 2019 Category: Consumer Health News Source Type: news

Australia ’s TGA considering, but not yet implementing, textured breast implant ban
Australia’s TGA said yesterday that it is seeking new data from suppliers of textured breast implants, which have been linked to a rare immune-system cancer, before making a decision on whether or not to suspend or cancel those products from its Register of Therapeutic Goods. The regulatory body gave suppliers of the devices 10 working days to respond to the requests for more information, including dates they began to supply the devices and samples of the implants, according to a TGA release. The decision comes after the convening of a breast implant expert panel on April 8, following recent decisions made in Canada ...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Oncology Regulatory/Compliance Women's Health Source Type: news

France Bans Textured Breast Implants
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 - April 8, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Regulatory and Compliance Source Type: news

Health Canada Plans to Suspend Allergan's Breast Implant License Health Canada Plans to Suspend Allergan's Breast Implant License
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)
Source: Medscape Medical News Headlines - April 5, 2019 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

Health Canada notifies Allergan on intent to suspend Biocell breast implant license
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 - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cosmetic/Aesthetic Regulatory/Compliance Women's Health Allergan Source Type: news

Report: France to ban textured breast implants
France is planning to ban textured breast implants, which have been linked a rare immune-system cancer, according to a report from France24. France’s National Agency for Medicines and Health Products began informing manufacturers on April 2 of its plans to ban manufacturing, distribution, importing, exporting, promotion and wearing of textured breast implants and polyurethane breast implants, according to the report. The soon-to-be-banned implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma. France’s ANSM has been tracking indivi...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Regulatory/Compliance Women's Health Source Type: news

France Is First to Ban Breast Implants Linked to Rare Cancer
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)
Source: NYT Health - April 5, 2019 Category: Consumer Health News Authors: CONSTANT MEHEUT Tags: Implants Breasts Plastic Surgery Accidents and Safety Allergan Inc France anaplastic large-cell lymphoma Source Type: news

Biocell textured breast implants could soon be pulled from the market: Health Canada
Sales of Biocell textured breast implants, which had been flagged for safety issues in a CBC News investigation, could soon be suspended, Health Canada says. (Source: CBC | Health)
Source: CBC | Health - April 4, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency. In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job. On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news

Mother, 29, claims her breast implants almost KILLED her
Gabrielle Case, of North Carolina, was fit and healthy until a year after having implants in 2015. She ended up bed-bound and struggling to breathe by December 2018. (Source: the Mail online | Health)
Source: the Mail online | Health - April 2, 2019 Category: Consumer Health News Source Type: news

More Info on Risks of Breast Implants Needed, Says FDA Panel More Info on Risks of Breast Implants Needed, Says FDA Panel
A 2-day meeting highlighted the risk for a rare lymphoma, described as a'man-made cancer,'and heard calls for a ban on certain products, but advisers also highlighted lack of data.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 27, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Women raise concerns about breast implant safety
Panel members in a two-day public hearing held by the US Food and Drug Administration this week agreed that efforts should be made to better inform patients about the risks and benefits of breast implants. (Source: CNN.com - Health)
Source: CNN.com - Health - March 27, 2019 Category: Consumer Health News Source Type: news

Women need better information on breast implants, panel says
Members of a Food and Drug Administration advisory committee scrutinizing the safety of breast implants urged the agency on Tuesday to take steps to ensure that patients have a clearer understanding o... (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - March 26, 2019 Category: Consumer Health News Authors: Laurie McGinley Source Type: news

FDA Panel: Too early to pull textured breast implants over cancer risk, need more data
A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report. The recommendation comes from the first day of a two-day panel meeting discussing the risks associated with breast implant devices, reviewing current study data and exploring how to best track and treat the cancer, and other issues, the devices have been tied to. The FDA only began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Oncology Women's Health Source Type: news

Breast surgeon "astonished" by cancer case amid FDA implant review
FDA is meeting to address the possible risks of breast implants after the agency reported that 457 cases of cancer have been detected in women with breast implants (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - March 26, 2019 Category: Consumer Health News Source Type: news

‘I was not warned’ - Women who say they were sickened by breast implants demand FDA action
At a hearing, patients, advocates, say the Food and Drug Administration should take steps to warn patients about risks of implants and take some devices off the market. (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - March 25, 2019 Category: Consumer Health News Authors: Laurie McGinley Source Type: news

Women who say they were sickened by breast implants demand FDA action: ‘I was not warned.’
At a hearing, patients, advocates, say the Food and Drug Administration should take steps to warn patients about risks of implants and take some devices off the market. (Source: Washington Post: To Your Health)
Source: Washington Post: To Your Health - March 25, 2019 Category: Consumer Health News Authors: Laurie McGinley Source Type: news

FDA reviews breast implant safety amid cancer concerns
In a two-day meeting, officials are hearing from researchers, plastic surgeons, and women who say they've suffered a number of ailments as a result of their breast implants (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - March 25, 2019 Category: Consumer Health News Source Type: news

Too soon to pull breast implants tied to cancer, U.S. panel
Patients, plastic surgeons, makers of breast implants, regulators and Health Canada officials participate in two-day meeting hosted by the U.S. Food and Drug Administration. (Source: CBC | Health)
Source: CBC | Health - March 25, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

Are Breast Implants Safe Enough? FDA Review Happening This Week
(CNN) — Many women have breast implants with no serious complications, but there have been cases where women suffer pain and fatigue, among other health problems. Now, the US Food and Drug Administration plans to hold a meeting to take a closer look at such cases and put breast implant safety under a microscope. The FDA will convene a meeting of the Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel on Monday and Tuesday to discuss and make recommendations relating to the risks and benefits of breast implants. The meeting, which will be open to the public, comes just days after the F...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - March 25, 2019 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News CNN Source Type: news

Are breast implants safe enough? The FDA reviews the popular procedure this week
Many women have breast implants with no serious complications, but there have been cases where women suffer pain and fatigue, among other health problems. (Source: CNN.com - Health)
Source: CNN.com - Health - March 25, 2019 Category: Consumer Health News Source Type: news

Health Highlights: March 25, 2019
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Panel to Revisit Breast Implant Safety The safety of breast implants will be in the spotlight once more during a two-day hearing before a... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 25, 2019 Category: General Medicine Source Type: news

J&J and Sientra get FDA warning letters over breast implants
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)
Source: CBC | Health - March 22, 2019 Category: Consumer Health News Tags: News/Health Source Type: news

Breast Implant ALCL: Excellent Prognosis if Treated Promptly Breast Implant ALCL: Excellent Prognosis if Treated Promptly
Clinicians encouraged to follow 2019 NCCN guidelines, discuss risks, symptoms as part of patient consent for textured breast implants.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 21, 2019 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

FDA Takes New Look at Breast Implant Safety
Agency has acknowledged that breast implants may contain materials that affect people's health (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - March 21, 2019 Category: Cancer & Oncology Tags: Gynecology, Oncology, Institutional, Source Type: news

FDA Busts J & amp;J and Sientra Over Breast Implant Compliance
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 ove...
Source: MDDI - March 20, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

J & J and Sientra get FDA warning letters over breast implants
The U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson& Johnson unit for failing to comply with the post-approval study requirements for their breast implants. (Source: Reuters: Health)
Source: Reuters: Health - March 20, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Reports of Breast Implant Illnesses Prompt Federal Review
The Food and Drug Administration is taking another look at breast implants because of renewed safety concerns. (Source: NYT Health)
Source: NYT Health - March 19, 2019 Category: Consumer Health News Authors: DENISE GRADY and RONI CARYN RABIN 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

FDA warns J & J, Sientra over lack of post-approval silicone gel breast implant studies
The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants. The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies of the devices to maintain appropriate data on the long-term safety and potential risks associated with the devices that premarket trials cannot foresee. In its letter to J&J&rsq...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Women's Health johnsonandjohnson Mentor Worldwide Sientra Source Type: news

FDA ramps up scrutiny of materials in medical devices
(Image by Michael Longmire on Unsplash) The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ &ld...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Cardiovascular Featured Food & Drug Administration (FDA) Implants Materials Testing Metal-on-Metal News Well Oncology Orthopedics Regulatory/Compliance Replacement Heart Valves Stents Surgical Women's Health ani Source Type: news

FDA Wants to Take a Hard Look at Medical Device Materials
As part of its effort to modernize its regulatory programs, FDA has turned its attention to materials used in medical devices.  The agency released a statement Friday from Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health that addresses recent advances in materials science and how these advances have impacted the safety of medical devices. "Materials used in today's medical devices vary as widely as the devices themselves—whether the material is metal, plastic, silicone, an animal-derived product or some combination of these," Got...
Source: MDDI - March 15, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Materials Regulatory and Compliance Source Type: news

Early menopause in smokers linked to bladder cancer
Longitudinal data used from over 220,000 nurses Related items fromOnMedica Breast cancer rate falls with decline in HRT use Only a third of women with regular bloating would see their GP Women consider legal action over cancer link breast implants Some irregular cervical lesions could be monitored rather that treated immediately Women who were not offered breast screening have been contacted (Source: OnMedica Latest News)
Source: OnMedica Latest News - March 15, 2019 Category: UK Health Source Type: news

Sientra plunges on Q4 earnings miss, clouded outlook
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 - March 13, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cosmetic/Aesthetic MassDevice Earnings Roundup Wall Street Beat Women's Health Sientra Source Type: news

Breast Implants Top List of Plastic Surgeries
The number of cosmetic procedures performed in the U.S. has climbed steadily over the past five years. (Source: WebMD Health)
Source: WebMD Health - March 11, 2019 Category: Consumer Health News Source Type: news

Mother, 28, has double D breast implants removed because the silicone 'was POISONING her'
Erika Ritschard, from Long Beach, Mississippi, had her silicone implants removed after five years because she said they were ageing her prematurely and wrecking her health. (Source: the Mail online | Health)
Source: the Mail online | Health - March 11, 2019 Category: Consumer Health News Source Type: news

Breast Implants Top List of Plastic Surgeries
MONDAY, March 11, 2019 -- More Americans than ever are trying to reshape their bodies with breast and butt implants, liposuction and " thigh lifts, " a new report shows. Almost 18 million cosmetic procedures were performed in the United States in... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - March 11, 2019 Category: General Medicine Source Type: news