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Trump’s pick for FDA to test ‘due diligence’ of Agency’s science – Bloomberg Law, November 25, 2024: Dr. Marty Makary has been named by Donald Trump to lead the FDA. The Johns Hopkins surgeon has been an outspoken critic of FDA’s relationships with industry and his appointment could shake up the status quo. NCHR and other experts are optimistic that Dr. Makary will encourage the agency to reduce conflicts of interest and hold industry to a higher standard for FDA approval of medical products and food safety.
Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself – The Washington Post, November 25, 2024: This news article quotes NCHR and other experts explaining that Vivek Ramaswamy is a former biotech executive who is very critical of the FDA in ways that reflect his extensive conflicts of interest. If Donald Trump follows Ramaswamy’s advice, Ramaswamy is likely to greatly increase his wealth and patients will be harmed by paying for expensive new medications that do not work.
F.D.A. names a new chief of medical devices – New York Times, Oct 22, 2024: Michelle Tarver is the new director of CDRH, FDA medical device center, promoted from within the agency. We are hopeful that she will move CDRH to focus more on ensuring safe and effective medical devices, reversing the bias of former director Jeff Shuren. But given her expertise, why has the agency failed to warn Lasik patients as promised?
He Regulated Medical Devices. His Wife Represented Their Makers. – The New York Times, August 20, 2024: Ever wonder why there are so many ineffective and unsafe implants and diagnostic tests and other medical devices harming patients? This NYT investigation explains how FDA official Jeff Shuren was involved in decisions that benefited his wife — who worked for Theranos and other major device companies. Why did FDA allow that to happen year after year?
A Special Report: Can Breast Implants Cause Chronic Disease? – This excellent review from HealthCentral.com quotes breast implant patients, NCHR and other experts responding to new FDA warnings and troubling research. We explain the research evidence of risks of breast implant illness and lymphoma and point out the misleading denials of risk by plastic surgeons.
Silicone Breast Implants Were Banned in the ’90s for Making Women Sick. How Did They Make a Comeback? – After a moratorium with loopholes, silicone gel implants became widely available in 2006. Breast implants were sold to millions of women before being studied on any women.
Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust – A Congressional report detailing coordinated attempts by Trump White House officials to influence the Food and Drug Administration’s pandemic response shows the need for more transparency at FDA to regain the public’s trust. The House Select Subcommittee on the Coronavirus Crisis reported that advisers to Donald Trump sought to build support for hydroxychloroquine as a Covid-19 treatment, despite no evidence that it worked, and to pressure the White House behind closed doors to authorize a COVID vaccine before the 2020 election.
Some policy watchers say it shows the FDA defended scientific evidence against efforts to politicize health policy. Others say any reports of attempted political interference is damaging to public trust in the FDA and other agencies. FDA Commissioner Robert M. Califf has said he will make combating health misinformation a priority. NCHR president Diana Zuckerman praised Califf for making it clear that he will not let the FDA’s reputation be undermined by misinformation.”
Danica Patrick reveals she had breast implants removed after suffering complications – Good Morning America, May 2, 2022: Former NASCAR driver Danica Patrick revealed she had her breast implants removed after suffering medical complications she believes were caused by the implants. We explain that her symptoms of breast implant illness were typical of breast implant illness, and she immediately felt better after the implants were removed.
Bella Hadid regrets getting a nose job at 14. How young is too young for plastic surgery? – Model Bella Hadid regrets getting a nose job at 14. USA Today asks NCHR’s Dr. Diana Zuckerman how young is too young for plastic surgery, and we explain how it depends on the situation but that teenagers are unlikely to make the best decisions and parents need help from surgeons to say “let’s wait.”
She’s the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants – Will this new law help women considering breast implants make informed medical decisions? The FDA took a step in the right direction but will doctors accurately inform their patients?
FDA’s agenda in limbo as Biden’s nominee stalls in Senate – Matthew Perrone, Fox13: February 08, 2022 WASHINGTON — (AP) — President Joe Biden’s pick to lead the Food and Drug Administration has stalled in the narrowly divided Senate, an unexpected setback that could delay decisions on electronic cigarettes and a raft of other high-profile health issues pending at the agency. Biden nominated Dr. Robert Califf for the … Continue reading FDA’s agenda in limbo as Biden’s nominee stalls in Senate →
What’s Wrong with the FDA? – Washington Monthly, January 20, 2022: If Robert Califf, the White House nominee for commissioner of the FDA, is confirmed by the Senate, he’ll take the reins of an agency with its reputation in tatters. Once revered as the global leader in drug regulation, the FDA has approved one bad drug and medical device after another over the past 30 years, leaving staff demoralized and overseas regulators scratching their heads. NCHR and other experts provide recommendations for improvements.
Breast Augmentation and Plastic Surgery Are on the Rise – What Are the Risks? – Honeysuckle Magazine, December 29, 2021: There has been a 33 percent increase in cosmetic surgery for women between 2000 and 2020. However, the measures meant to guarantee their safety are disputed among experts such as the National Center for Health Research.
Biden’s Drug Agency Nominee Returns With Deeper Industry Ties – Bloomberg Business, November 23, 2021: President Biden’s choice to lead the FDA made millions of dollars from health and drug companies since his last stint in government, raising new questions about his ties to firms the agency oversees.
Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties – The New York Times, November 12, 2021: Is Biden nominee Dr. Califf the best choice to head up the FDA. The New York Times describes his pros and cons, and we point out that the White House doesn’t mind his Pharma ties.
Biden picks ex-FDA chief Robert Califf to again lead agency – AP News, November 12, 2021: Robert Califf will be nominated as FDA Commissioner today. We told AP “He knows how the FDA works, and he avoided making any outrageous decisions as commissioner. Those are essential if the FDA is going to regain the public trust.”
Biden expected to tap Califf as FDA commissioner – Roll Call, November 12, 2021: Robert Califf will be nominated to again serve as FDA commissioner. We tell Roll Call that he’s a political compromise, close to Pharma but avoiding the controversy that happens when FDA ignores scientific evidence.
Biden chooses Robert Califf, former Obama FDA chief, as agency commissioner – Washington Post, November 12, 2021: President Biden is expected to nominate former FDA Commissioner Robert Califf to return as the agency’s head, and we explain why this political compromise makes sense despite his industry ties.
Breast Implants will now come with Black Box Warnings, List Risks – Legal Reader, November 9, 2021: Will FDA’s requirements to warn patients about the cancer risks and other serious risks of breast implants be enough to adequately warn women considering implants? Experts disagree.
When it comes to clinical trials, healthcare’s diversity problem is standing in the way of medical advancement – Fortune, November 5, 2021: The lack of diversity in clinical trials is standing in the way of medical advancement. NCHR president Dr. Diana Zuckerman explains how that delayed progress in treating triple negative breast cancer, which is more common among Black women.
FDA approves new restrictions, orders stronger warnings for breast implants – CBS 5, October 27, 2021: The U.S. Food and Drug Administration added new restrictions to who can sell and distribute breast implants and approved new labeling for all FDA-compliant implants. Dr. Diana Zuckerman spoke with CBS 5 on the need for more comprehensive warnings to patients.
Patients Must Be Warned of Breast Implant Risks, F.D.A. Says – The New York Times, October 27, 2021: The FDA has placed black box warnings on breast implant packaging and told manufacturers to sell the implants only to health providers who review the potential risks with patients before surgery. The National Center for Health Research asks who will enforce that?
FDA continues operating without a Senate-confirmed, permanent leader – Homeland Preparedness News, September 28, 2021: Should you be concerned about the lack of a permanent FDA Commissioner? NCHR explains why the new Commissioner needs to be someone who cares about public safety and public health.
Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data – BMJ, August 20, 2021: The FDA is being criticized for not holding an advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Will it undermine public confidence?
Beleaguered FDA in talks for drug-company funding – Marketplace, July 13, 2021: Fees paid by drug companies make up half of the FDA’s revenue. Dr. Diana Zuckerman explains how these fees often influence FDA decisions and sacrifice patient safety.
Former ‘Bachelorette’ Clare Crawley Is Removing Her Breast Implants Over Health Concerns—Here’s What to Know – Health, July 6, 2021: Former ‘Bachelorette’ Clare Crawley says “As much as I love my implants, my body is fighting them,” she says. NCHR’s president helps explain why.
My breast implants are making me sick — and I’m not alone – Salon, June 20, 2021. It’s not in our heads: More women are speaking up about how their breast implants are making them sick. And Healing Breast Implant Illness Society of North America and National Center for Health Research are making sure women know they are not alone.
4 in 10 Adults Over 50 Consult Online Reviews When Picking a Doctor – HealthDay, April 14, 2021. Finding a new doctor can be a daunting task. For help, many older adults turn to online reviews, a new study finds. In fact, many people rate online reviews as highly as they would a recommendation from friends and family when picking a doctor. Dr. Diana Zuckerman, president of the National Center for Health Research, said that choosing a doctor is a complex undertaking.
What Genentech is doing to fix biotech’s diversity problem – Fortune, April 7, 2021. There’s a big problem with clinical trials: a lack of diversity. This problem led researchers to believe that Black women did not develop breast cancer as frequently as white women and created a gap in understanding how different treatments work. How can companies like Genentech start increasing diversity in clinical trials?
Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL – Cancer Therapy Advisor, February 8, 2021. Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field, including Dr. Diana Zuckerman of the National Center for Health Research and their Cancer Prevention and Treatment Fund.
Congressman calls for FDA to continue vaccine trials – ABC, December 29, 2020. Rep. Llyod Doggett of Texas wrote to the FDA urging COVID-19 clinical trials to continue until they have more data.
Covid-19: Should vaccine trials be unblinded? – Jeanne Lenzer, BMJ: December 29, 2020. The lack of planning for how to treat participants in covid-19 vaccine trials is a bad precedent, with the loss of potentially valuable safety and efficacy data, say research experts. Jeanne Lenzer reports: In October the US Food and Drug Administration issued non-binding guidance to manufacturers of covid-19 vaccines urging … Continue reading Covid-19: Should vaccine trials be unblinded? →
FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine – NPR, October 22, 2020. Dr. Diana Zuckerman spoke about testing for vaccine safety at the FDA advisory meeting on Covid-19 vaccine approval.
Study finds removing breast implants improved symptoms – AzFamily.com, October 1, 2020. The FDA is finally encouraging better information about the risks of cancer, breast implant illness, and other health problems for women considering breast implants. But we agree with patients that the agency could do so much more.
FDA Updates Breast Implant Labeling Recommendations to Help Inform Patients About Dangerous Potential Side Effects – Cure, September 29, 2020. Makers of breast implants should include a black box warning about cancer and other serious risks, along with a patient decision checklist for patients to sign, according to final guidance issued by the FDA.
First, Their Breast Implants Made Them Sick. Then They Were Hit with the Bill. – Cosmopolitan, August 18, 2020. Insurance companies rarely cover the costs of breast implant removals, even when they make women really sick.
The Number Of Women Having Their Breast Implants Removed Is on the Rise – Women’s Health, August 8, 2020. A growing number of women, especially athletes, are having their breast implants removed to alleviate symptoms of breast implant illness.
New Study Backs Breast Implant Illness Claims by Patients – International Consortium of Investigative Journalists, July 2, 2020. A study in a leading plastic surgery journal offers more evidence to support the existence of breast implant illness, a malady reported by thousands of women but dismissed as scientifically unproven by many plastic surgeons and some health authorities.
Women with Breast Implants Should Not Need to Wait for Safety Information They Urgently Need – Our Bodies, Ourselves, July 1, 2020. In response to the demands of thousands of breast implant patients, the FDA proposed that a black box warning be affixed to all implant packages to inform women and their doctors about the most serious risks of breast implants.
“We Can’t Ever Go to the Doctor with Our Guard Down”: Why Black Women Are 40% More Likely to Die of Breast Cancer – Fortune Magazine: June 30, 2020 Black Americans are dying from the COVID-19 pandemic at a disproportionately high rate, and are also much more likely to die from many other health problems. Black women are less likely to develop breast cancer but 40% more likely to die from it than White women. The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it.
CRS: Congress Can Rein in FDA’s Flexible Covid-19 Vaccine Trial Policies – Inside Health Policy, June 03, 2020. The Congressional Research Service says Congress could rein in FDA’s COVID-19 policies by passing a law, and NCHR explains why that is a good idea.
Allergan is trying to track down women with breast implants it recalled nearly a year ago – Fortune, June 3, 2020. FDA has asked small nonprofit organizations to help inform tens of thousands of women that they have a type of breast implant that has been recalled due to increased cancer risks.
A Patient’s Guide to Telemedicine – Drugwatch, May 20, 2020. NCHR advises Drugwatch about preparing ahead of time for telemedicine visits in order to make the best out of the appointment.
FDA Warns Allergan Over Breast Implant Studies – International Consortium of Investigative Journalists, May 19, 2020. The FDA warns Allergan over failure to complete breast implant studies.
‘They killed her’: Why are breast implants still putting millions of women at risk? – Fortune, May 18, 2020. Breast implants and the other “medical aesthetics” products that are driving profits are also endangering women’s health.
Tests for COVID-19: Has the FDA said yes too many times? – The Hill Opinion Contributors, May 6, 2020. Most tests being sold in the U.S. aren’t proven to be accurate by unbiased scientists. Here’s what you need to know.
Coronavirus Relief Act Gives Drug Makers New Sway Over FDA – Pogo, May 5, 2020. Under the $2 trillion coronavirus relief law, makers of over-the-counter drugs will pay the FDA to oversee their products and will gain new sway over the consumer protection agency.
FDA considers black box warning for all breast implants – WCPO Cincinnati, February 09, 2020. The FDA may finally require blackbox warnings for women considering breast implants, due to complications connected to implants after a mastectomy.
No Shortage of Controversies for New FDA Commissioner – The Wall Street Journal, January 29, 2020. New FDA Commissioner Stephen Hahn faces tug of war over controversial issues in health, including e-cigarettes, stem-cell research, and the use of cannabidiol (CBD).
Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound – FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020, according to device center Associate Director for Compliance and Quality Erin Keith. Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating … Continue reading Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound →
Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t. – 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 companies. […] In recent years, internal … Continue reading Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t. →
Report Claims More Women than Men Injured by Medical Devices – The ICIJ used the Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database to conduct the research. This data is publicly available and contains eight million reports which have been filed by doctors, patients and manufacturers when a medical device is suspected of putting someone at risk, causing injury or resulting in death. … Continue reading Report Claims More Women than Men Injured by Medical Devices →
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.
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.
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 →
How Safe Are Breast Implants, Really? – Elemental by Medium: September 3, 2019. How safe are breast implants really? The answer is complicated.
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.
Kris Pickel, CBS 5 Investigates up for national Emmy for breast implants illness stories – Arizona Family: July 31, 2019. Thanks to Kris Pickel, for her Emmy nominated investigative series on breast implant illness! We were glad to work with Kris on this important investigation!
Why Everyone Is Talking About Breast Implant Safety Right Now – Allure: July 29, 2019. Allure quotes us pointing out how little is known about which breast implants are safest and for whom. But many plastic surgeons continue to claim that breast implant illness is a combination of common symptoms that many people have even if they don’t have implants. Not true.
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 Breast Implants Linked To Cancer Recalled After FDA Request – NBC: July 24, 2019. NCHR president explains to NBC News why recalling Allergan textured breast implants is “an important step” to improve patients’ safety.
Allergan Recalls Textured Breast Implants Globally Due to Cancer Links – ICIJ: July 24, 2019. Women considering breast implants shouldn’t have to worry that they will cause cancer, NCHR president tells investigative journalists at ICIJ.
Allergan Recalls Textured Breast Implants Linked to Rare Cancer – Washington Post: July 24, 2019. Allergan finally recalled their biocell textured breast implants because of the evidence that they can cause cancer. We thank the FDA for urging the company to recall these implants and we hope that the delay hasn’t harmed many patients.
Allergan Recalls Textured Breast Implant Tied to Rare Cancer – ABC Action News: July 24, 2019. NCHR president points out that the removal of Allergan biocell textured breast implants was inevitable because patients had died from lymphoma caused by the implants. Why weren’t they recalled sooner?
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.
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 Reviews Breast Implant Safety as Women Raise Concerns – FoxNews 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?
Leaking Breast Implants Leave Women Fighting Infections, Insurers – Bloomberg Law: April 8, 2019. Women with breast implants are facing health problems due to leaking devices, and insurers are hesitant to pay for removal.
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.
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.
Mum Has Double-D Breast Implants Removed After Becoming Convinced They Were Poisoning Her – Metro News: March 11, 2019. A mother from Mississippi had her implants removed as she was convinced that they were causing her horrific health problems.
The Implant Files Sparked Reform Around The World. Here’s Why We’re Still Reporting. – ICIJ: February 27, 2019. The International Consortium of Investigative Journalists continue to scrutinize implants and their effect on people worldwide.
Mother Who Got Breast Implants to Fix Her ‘Mom Bod’ Suffered Horrific Reaction – Daily Mail, February 21, 2019. A mother who got breast implants had such a severe autoimmune reaction that evaporated once the implants were removed.
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.
Breast Implants: the Trouble is Under the Skin – Radio-Canada Info, November 2018. This video looks at the troubling effects breast implants have on women and how healthcare systems are letting them down.
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’ – Daily Mail, December 2018. 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.
US Goal to be “First” on Devices Worries Former Regulators – Associated Press, 2018. As part of an investigation of ineffective and unsafe medical devices, this AP article explains that the Device Center leadership has changed his focus from safety to “We want the US to be first” to get devices on the market.
Breast Implant Injuries Hidden As Patient’s 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.
Silicone Breast Implants Increase Arthritis Risk 600%, Stillbirth Risk 450% and Skin Cancer Risk 400%, Study Claims – Daily Mail, November 2018. MD Anderson Cancer Center’s study reports huge increases in risk for arthritis, stillbirths, and skin cancer, among others.
Doctors, Patients Raise Alarms About Cancer Linked to Breast Implants – NBC News, November 11, 2018. There is an association that has been established between a form of cancer (ALCL) and breast implants.
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.