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.
NCHR Letter Concerning Lead in DC Public School Playground – After lead was found in the playground at Janney Elementary School in Washington, DC, NCHR wrote a letter to DC Education Officials.
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.
Medical Device Dangers: FDA Facing Criticism Over Missed Signs – Today News: November 26, 2018. In this news segment, NCHR’s Jack Mitchell discusses how device safety is handled by the FDA compared to other countries.
Doctors, Patients Raise Alarms About Cancer Linked to Breast Implants – Lauren Dunn and Maggie Fox, NBC News: November 26, 2018. When Michelle Forney’s breast started swelling and itching, doctors told her she had mastitis, a common infection, and treated her with antibiotics. When she discovered that she, in fact, had a rare form of lymphoma and that it was probably caused by her breast implant, … Continue reading Doctors, Patients Raise Alarms About Cancer Linked to Breast Implants
Breast Implant Injuries Hidden as Patients’ Questions Mount – Associated Press, 2018. Women have been having problems with breast implants for decades. NCHR president tells AP that the safety studies on breast implants should be questioned.
Breast Implant Illnesses: What’s the Evidence? – A large meta-analysis of the current cornerstone breast implant illnesses research studies reveals their weaknesses and highlights what is known.
Concerns That Public Hearings on Breast Implants Will Favor Implant Manufacturers – CBS News: Oct 4, 2018. Women become ill from their breast implants and we are concerned about whether the FDA is listening to patients or plastic surgeons.
Summary of Published Study by MD Anderson Physicians on the Increase in Rare Diseases Among Women with Breast Implants – We summarize the study conducted by MD Anderson Cancer Center regarding the incidence of rare diseases among women with breast implants.
Statement of Dr. Diana Zuckerman, President of the National Center for Health Research Regarding the New Study of 100,000 Women with Breast Implants – Dr. Diana Zuckerman, the president of NCHR, makes a statement in support of the newly released MD Anderson study that shows breast implants are linked to illness.
F.D.A. Targets Vaping, Alarmed by Teenage Use – New York Times: Sept, 2018. Although the FDA sees their first “crackdown” on vaping products, are they actually doing enough to protect teens and others from these harmful products?
FDA Rarely Uses Its Power to Recall Dangerous Medical Devices. Why Not? – Meg Bryant, MedTech Dive: August 31, 2018. Dr. Zuckerman remarks about the process of taking a device off the market in a recall, and why it’s rarely done.
New Drugs So Pricey They Need New Payment Plans – Sarah Owermohle, Politico: August 13, 2018. FDA intends to speed up certain early and mid-stage clinical trials for oncology drugs by merging elements typically found in phase 1 and phase 2 trials.
The Human Tragedy of Poorly Regulated Medical Devices Gets the Spotlight in a Netflix Film – Amy Martyn, CBS News: July 27, 2108. NCHR president speaks out about medical devices, spurring filmakers to make documentary available on Netflix. The documentary discusses the human side of faulty medical devices being released to the market.
FDA Expedited Approval Process Raises Concerns About Risks – Roxanne Nelson, FDA: July 18, 2018. Expedited approval process by the FDA for drugs raises concerns for safety of consumers.
To Improve Treatments, Researchers Want To Hunt For Clues In Medical Records – Richard Harris, NPR: July 15, 2018. While researchers consider using electronic medical records to improve treatments, NCHR president spreads caution.
FDA Repays Industry by Rushing Risky Drugs to Market – ProPublica, June 26, 2018. As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.