Everything is designed for men, even drugs – Vox, January 16, 2020. Designing medicine around the “average man” is so dangerous. We need more inclusivity in clinical trials — for women, for people over 65, and for people of color.
Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound – MedTech Dive, January 10, 2020. FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020.
Schools Seek Ways to Curb Vaping Among Students – The Wall Street Journal, January 6, 2020. With the rise of vaping related illnesses, schools turn to new tactics to deter students from vaping.
Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels – MedTech Dive, December 23, 2019. As the FDA approves medical devices, it is essential that the public is made aware of inadequate post-approval studies and spotty adverse event reporting.
I Visited a ‘Private ER’ Where People Pay Up to $5,000 a Year to Skip the Hospital— Take a Look – Insider, December 19, 2019. The ER system is broken; the country’s emergency medicine system is misused, overused, and wildly expensive.
Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t. – Annie Waldman, ProPublica, December 6, 2019 For nearly two decades, Dr. Neal Hermanowicz has led the movement disorders program at the University of California’s Irvine campus, where he earns more than $380,000 a year in salary and bonuses. The widely respected expert on Parkinson’s and Huntington’s diseases adds to his income by consulting for drug … Continue reading Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t.
Not Just Blowing Water — Vaping Presentation Will Sort Myth and Reality – Walla Walla Union Bulletin, December 3, 2019. As school districts nationwide have been caught flat-footed and struggle to banish vaping on campuses, the short term effects of vaping having seemingly created significant and life changing health issues.
How Minnesota Schools are Doubling Down on Anti-vaping Efforts – MinnPost, December 2, 2019. Teens and young adults make up the bulk of those vaping-related hospitalizations resulting from serious lung damage, causing Minnesota schools to double down on anti-vaping efforts.
Report Claims More Women than Men Injured by Medical Devices – Medical Plastics News, November 28, 2019. A report published by the International Consortium of Investigative Journalists has revealed more women than men have been injured by a medical device.
FDA Challenged Over Metal Implants ‘Public Health Travesty’ – International Consortium of Investigative Journalists, November 14, 2019. The FDA needs to require better research before implants are approved and put in patients’ bodies, instead of just counting problems after the implants are used by thousands of patients.
FDA Advisers Hear About Problems, Research Needs With Metal Implants – MedPage Today, November 14, 2019. Comparing different implants could prevent many women and men from harm resulting from metals and other substances that set off negative reactions in patients.
FDA’s Special Treatment Of Big Tech Faces Mounting Scrutiny – Kevin Stawicki, Law360, November 12, 2019. The U.S. Food and Drug Administration is taking heat from prominent lawmakers over a special approval pathway for health software products sold by Apple, Samsung and other major tech companies, opening the door to a congressional showdown over whether the agency has the right to start such a program. The … Continue reading FDA’s Special Treatment Of Big Tech Faces Mounting Scrutiny
How the FDA and EPA’s failure to communicate could put patients in danger – Politico, November 7, 2019. While EPA wants to shut down facilities that sterilize medical devices using a carcinogenic chemical, the EPA and FDA should have harmonized their standards years ago to protect patients and consumers.
FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns – Sydney Lupkin, Kaiser Health News and Daily Beast: November 3, 2019. After unanimously voting to recommend a miraculous hepatitis C drug for approval in 2013, a panel of experts advising the Food and Drug Administration gushed about what they’d accomplished. What the panelists didn’t know was that the FDA’s drug quality inspectors had recommended against … Continue reading FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns
When Recalls Fail: Many harmful products remain in homes and stores. Why that happens, what needs to change, and how to protect yourself. – Consumer Reports, October 31, 2019. Whether it be contaminated food, deadly infant sleepers, breast implants, or other unsafe products, recalls are not protecting us as well as they should be.
FDA calls for new warnings for breast implants – The Washington Post, October 23, 2019. Due to problems with breast implants, FDA calls for new warnings associated with the implants as well as providing more information about the devices.
Women Should Be Warned of Breast Implant Hazards, F.D.A. Says – NY Times, October 23, 2019. In light of breast implant hazards, FDA proposes that surgeons discuss the risks with patients and that manufacturers print bold warnings on the device packaging.
Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants – Statement of Dr. Diana Zuckerman, President, National Center for Health Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants. The FDA’s draft … Continue reading Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants
Hospitals Push Women to get 3D Mammograms, Despite No Evidence they Save More Lives – Fox Business, Yahoo Finance, and other media outlets: October 20, 2019. Hospitals are pushing women to get 3D mammograms, which is not only more expensive, but also lacks sufficient evidence to show that they save more lives than traditional mammograms.
Breast implants, heavy metals & autoimmune disorders: What should be in FDA warnings? – AZ Family, October 18, 2019. As the FDA considers issuing stronger warnings on breast implants Dr. Diana Zuckerman explains the flaws in the original clinical trials.
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.