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Massive Marketing Muscle Pushes 3D Mammograms, Despite No Evidence They Save More Lives, Investigation Shows Liz Szabo, USA Today: October 18th, 2019. When Dr. Worta McCaskill-Stevens made an appointment for a mammogram last year, she expected a simple breast cancer screening – not a heavy-handed sales pitch. A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis. “She said there’s a new approach and it’s … Continue reading Massive Marketing Muscle Pushes 3D Mammograms, Despite No Evidence They Save More Lives, Investigation Shows
Some textured implants have a cancer risk. Here’s why women are told not to remove them WJLA: September 16, 2019. Should women with textured #breastimplants have them removed even if they don’t have lymphoma symptoms? We tell ABC7 not necessarily.
What Does Vaping Do To Your Lungs? Here’s What We Know Elite Daily: September 11, 2019. We tell EliteDaily the latest on what you need to know about the known and unknown risks of vaping.
How Safe Are Breast Implants, Really? Elemental by Medium: September 3, 2019. How safe are breast implants really? The answer is complicated.
E-cigarettes affect a person’s blood vessels after just one use, study finds CBS News: August 22, 2019. E-cigarettes may reduce blood flow in femoral artery after just one use, study finds; long-term effects unknown.
Teens Hospitalized for Lung Damage After Vaping Fox & Friends: August 17, 2019. As a rising number of teens are hospitalized after vaping, Dr. Diana Zuckerman urges parents to take action.
Teens are being hospitalized for lung damage after vaping — “It’s mind-boggling,” doctor says CBS News: August 13, 2019. NCHR President Dr. Diana Zuckerman warns that long-term consequences associated with vaping are not yet fully understood.
What’s behind the surge of prescriptions for risky, expensive medications? Millions from drugmakers. Milwaukee Journal Sentinel: August 8, 2019. Biologic drug companies use a variety of strategies to make millions at the expense of patients.
How to Read a Drug Label Michelle Llamas, DrugWatch: July 31, 2019 Update. Consumers should always read drug labels to make sure they are taking a medication correctly and safely as well as to learn about possible side effects. Unfortunately, these labels can be challenging for the average person to digest. If you struggle to make sense of the information on … Continue reading How to Read a Drug Label
Why Everyone Is Talking About Breast Implant Safety Right Now Michelle Stacey, Allure: July 29, 2019. Candyce Kirbyson wanted a bit more. At 105 pounds, she had A-cup breasts. So at 32, the Seattle-area mom decided to get implants. But she got a lot more. A laundry list of ailments, in fact. Hives and muscle weakness. Numbness and tingling in her arms and legs. Insomnia and … Continue reading Why Everyone Is Talking About Breast Implant Safety Right Now
Breast Implants Linked to Rare Cancer Are Recalled Worldwide Denise Grady, The New York Times: July 24, 2019. Textured breast implants made by Allergan that have been linked to an unusual cancer are being recalled in the United States at the request of the Food and Drug Administration, and will also be recalled globally, the agency announced on Wednesday. The F.D.A. decision, based on an … Continue reading Breast Implants Linked to Rare Cancer Are Recalled Worldwide
Allergan Recalls Textured Breast Implants Globally Due to Cancer Links Sasha Chavkin, IJIC: July 24, 2019. Allergan will recall its Biocell textured breast implants worldwide after United States health authorities requested that it remove them from the market due to their association with a rare cancer of the immune system. The announcement, which reflects the most sweeping recognition to date of the serious health risks associated with … Continue reading Allergan Recalls Textured Breast Implants Globally Due to Cancer Links
Allergan Recalls Textured Breast Implants Linked to Rare Cancer Laurie McGinley, Washington Post: July 24, 2019. Allergan announced a worldwide recall of textured breast implants Wednesday after the Food and Drug Administration found a sharp increase in a rare cancer and deaths linked to the products and asked the company to pull them off the U.S. market. The Dublin-based company said it is recalling Biocell textured … Continue reading Allergan Recalls Textured Breast Implants Linked to Rare Cancer
Allergan Recalls Textured Breast Implant Tied to Rare Cancer Matthew Perrone, AP for ABC Action News; July 24, 2019 WASHINGTON (AP) — Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer. The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast … Continue reading Allergan Recalls Textured Breast Implant Tied to Rare Cancer
Dr. Diana Zuckerman’s Statement on FDA’s Request for Recall of Allergan Breast Implants and Expanders When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma.  This recall will reduce that risk but it won’t eliminate it.
More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database Sydney Lupkin and Christina Jewett, KHN; May 30, 2019 | Thousands of patients were harmed and dozens killed by malfunctioning surgical staplers. Most of that information was hidden in an FDA database that was not publicly available, which NCHR criticizes as covering up information patients and physicians need to make informed decisions.
How the FDA Handles Recalls of Life-Saving Implants Could Put People at Risk, Patients Say Nicole Carr, WSBTV; May 20, 2019 Geraldine Robinson is one of millions of Americans who use an implanted medical device to improve, and possibly extend her life. But when the implant was recalled years later, nobody told her. We help explain why.
FDA Ending Controversial ‘Alternative Summary Reporting’ Program DOTMed News: May 8, 2019. The FDA’s alternative summary reporting system hid information about patients who were harmed by medical devices. FDA says it will stop this cover-up and require reporting of each patient harmed by a device.
FDA Will Not Ban Textured Breast Implants at this Time NBC News: May 3, 2019. After years of reports of safety concerns regarding textured breast implants, they will not be removed from the market, says FDA.
Breast Implants Linked to Rare Cancer Get OK to Stay on U.S. Market New York Daily News: May 2, 2019. After reviewing the evidence that textured breast implants are linked to cancer, the FDA allows them to stay on the market.
Is the 21st Century Cures Act a Solution or a Problem? The Regulatory Review: May 7, 2019. The 21st Century Cures Act is costing patients their life savings but not effectivel saving lives.
80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices. New York Times: May 4, 2019. Like all medical devices, breast implants concern patients who suffer as the FDA fails to adequately screen/monitor products.
Breast Implants Tied to Rare Cancer to Remain on US Market Associated Press: May 2, 2019. Though textured breast implants are tied to ALCL, a form of cancer, they’re allowed to stay on the market by the FDA.
FDA Allows Breast Implants Linked to Rare Cancer to Remain on the Market Philadelphia Inquirer: May 2, 2019. Despite their known link to cancer, the FDA lets textured breast implants stay on the market.
FDA Won’t Ban Breast Implants Linked to Cancer at This Time Washington Post: May 2, 2019. The FDA finally almost acknowledges that women are getting sick from breast implants. Progress is too slowly being made.
FDA Orders Makers of Women’s Surgical Mesh to Stop Selling the Products Wall Street Journal: April 16, 2019. Due to lacking safety and effectiveness data, the FDA has ordered use of surgical mesh for pelvic organ prolapse in women to be stopped.
FDA Stops Sales of Transvaginal Mesh for Pelvic Organ Prolapse Drug Watch: April 16, 2019. The FDA has stopped the sales of transvaginal mesh for use in pelvic organ prolapse due to safety concerns.
FDA Progressive Device Approval Proposal Raises Eyebrows MedTech Dive: April 16, 2019. The FDA’s device approval process’ standards are lowering, and we strongly oppose this radical new proposal.
FDA Reviews Breast Implant Safety as Women Raise Concerns FoxNews: April 11, 2019. Fox interviews a woman with breast implants who is getting them removed to improve her health, and we are interviewed explaining that some implants are probably safer than others and some women more likely to be harmed. FDA keeps saying there isn’t enough evidence, but whose fault is that?
France Bans Breast Implants Amid Cancer Suspicions Longevity: April 5, 2019. After evidence emerged linking breast implants with ALCL, France becomes the first to ban the implants from the market.
Are Breast Implants Safe? FDA is Looking into Claims CBS5 News: March 25, 2019. CBS reports on the FDA advisory committee meeting that discussed the safety of breast implants.
Device-Safety Experts to FDA: Make Data Public NBC News: March 27, 2019. After exemptions the FDA made to manufacturers who were supposed to provide data, experts call for required information.
Women Need Better Information on Breast Implants, Panel Says Washington Post: March 26, 2019. After two days at the FDA, panelists say women need more information about the risks of breast implants before surgery.
Women Who Say They Were Sickened by Breast Implants Demand FDA Action: ‘I Was Not Warned.’ Washington Post: March 25, 2019. At an FDA advisory committee meeting, women who were harmed by breast implants say they were not warned of the risks.
US Experts: Too Soon to Pull Breast Implants Tied to Cancer Associated Press: March 25, 2019. At an FDA advisory committee meeting for breast implants, experts say it’s too soon to ban implants that cause ALCL.
FDA Takes Hard Look at Breast Implant Safety Amid Fresh Cancer Fears MedTech Dive: March 21, 2019. Recent connections of breast implants to cancer (ALCL) have forced the FDA to take a hard look at these implants’ safety.
FDA Slams Breast Implant Makers in Warning Letters Days Before Federal Hearing that Could Ban Them from the US Market The Daily Mail: March 20, 2019. The FDA has finally issued warnings to two breast implant makers notifying them of incomplete safety studies that were mandatory for the implants to be on the market.
FDA Issues Warning to Two Breast Implant Makers NBC News: March 19, 2019. The FDA released warning letters to two breast implant manufacturers in light of large numbers of women reporting complications.
Reports of Breast Implant Illnesses Prompt Federal Review New York Times: March 19, 2019. With an overwhelmingly large number of women reporting adverse effects to their breast implants, collectively known as breast implant illness, the FDA finally agrees to review the devices.
What Does Gottlieb’s Resignation Mean for Medtech? Medtech: March 6, 2019. FDA Commissioner Scott Gottlieb sent in his resignation, but what does it mean for drug and device safety? NCHR President, Dr. Zuckerman, weighs in.
Double-Booked Surgeons: Study Raises Safety Questions For High-Risk Patients NPR: February 26, 2019. A study shows that surgeons who leave the operating room before the surgery is over do not put the patient at a much greater risk.
Is FDA Doing Enough to Make Sure Sunscreens are Safe? NCHR supports the FDA’s issued guidance regarding sunscreen sold over-the-counter that contains ingredients not thoroughly studied.
Policing Big Pharma’s Influence Over Doctors’ Treatment Guidelines Medical treatment guidelines are supposed to advise doctors how best to treat their patients. But what if the guidelines are written by doctors who are paid by particular pharmaceutical or device companies? Even if your doctor doesn’t take money from Pharma, how will biased guidelines affect what your doctor recommends to your treatment?
Municipal and Schools Budgets Proposed for FY ’19-20, Public Comments Focus on Turf, Ice Rink Greenwich Free Press: January 25, 2019. NCHR’s president, Dr. Zuckerman, traveled to Connecticut to present information on artificial turf fields.
Health Care Industry Spends $30 Billion a Year on Marketing NBCnews.com: January 8, 2019. Drug companies spend $30 billion a year on ads and marketing, but we’re all paying for all of those ads.
The FDA is Still Letting Doctors Implant Untested Devices into Our Bodies Washington Post: January 4, 2019. Why are unsafe medical devices implanted in our bodies? How thoroughly are they tested for safety? The news is surprising.
29-Year-Old Fitness Model Gets Breast Implants Removed after She Says the Silicone Gave Her Seven Years of ‘Brain Fog, Bald Spots and Rashes’ A young fitness blogger gets breast implants and her health deteriorated dramatically. Two weeks after her explant, she is already recovering from her symptoms. NCHR president explains that this is a risk for all women, and especially those with a family history or personal history of autoimmune or connective tissue diseases.
FDA Recommends “Modernizing” Review of Devices in Wake of Global Investigation British Medical Journal: November 27, 2018. While FDA commissioner Scott Gottlieb recommends medical device approval reform, NCHR says it is not enough.
After Years of Complaints, U.S. and U.K. Officials Say They Want to Reform the Medical Device Industry Consumer Affairs: November 29, 2018. The US and UK are making demands to the medical device industry for safer and more effective products.
Here’s What We Know About Breast Implants and This Rare Type of Cancer SurvivorNet: November, 2018. Ties have been made between breast implants and ALCL, a rare cancer. Patients feel betrayed by doctors who fail to warn them.