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Medical Devices
Multistate Oximeter Lawsuit Alleges Device Racism Bias
MedTruth Editors · November 14, 2023
It has been known for decades that people with darker skin tones can have reduced accuracy when their oxygen saturation is measured with a pulse oximeter.
NewsHernia Mesh Bellwether Date Set
MedTruth Editors · October 5, 2023
Plaintiffs allege that Covidien designed defective hernia meshes that caused pain and debilitating, sometimes life-altering complications after implantation.
Legal DevelopmentsParagard Adverse Events Mount Alongside Growing Litigation
MedTruth Editors · September 26, 2023
As reports mount, more people are taking legal action for injuries allegedly connected to the Paragard non-hormonal IUD.
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Philips C-PAP Settlement Nears $500 Million
MedTruth Editors · September 21, 2023
While this settlement partially reimburses plaintiffs who bought a device that allegedly led to cancer, lung damage, breathing problems, and other injuries, it does not resolve any of the claims that Philips’ device caused these injuries.
Legal DevelopmentsBard IVC Filter Verdict Upheld on Appeal
MedTruth Editors · August 31, 2023
The court ultimately sided with the plaintiff, upholding the decision that Bard's IVC filter caused injuries to a nurse.
Legal DevelopmentsBard Port MDL Assigned to Arizona
MedTruth Editors · August 25, 2023
The Bard PowerPort is a subcutaneous, implantable port catheter system that delivers medications such as chemotherapy drugs.
Legal DevelopmentsMedtronic Accused of Bribery Scheme
MedTruth Editors · August 24, 2023
According to the lawsuit, members of a Kansas VA hospital were allegedly bribed to purchase additional, unnecessary products that were then used on patients.
NewsBard PowerPort Device May Generate Thousands of Lawsuits
MedTruth Editors · July 13, 2023
This catheter device has a risk of fracture, which results in pieces migrating into the body, causing chest pain, blood clots, and blockages in the pulmonary arteries.
NewsJ&J Hip Implant Allegedly Caused Heavy Metal Poisoning
MedTruth Editors · May 9, 2023
A woman claims her Pinnacle metal hip implant gave her heavy metal poisoning and forced her to undergo surgery.
NewsDental Device AGGA Sued For Allegedly Damaging Teeth
MedTruth Editors · March 24, 2023
The dental device is intended to expand the jaw without the need for surgery, but experts say patients’ teeth showed signs of being displaced rather than expanded.
NewsLate 2022 Reports Added to CPAP Device Communication
MedTruth Editors · March 14, 2023
Medical device reports received by the FDA at the end of 2022 have now been added to CPAP safety communication for public examination.
FDA RegulationFDA Issues Endoscope Warning Letters
MedTruth Editors · January 26, 2023
After a series of facility inspections, the leading manufacturer of endoscopes was found to have violated medical device reporting requirements and quality system regulations.
FDA RegulationNew Research Questions FDA Fast-Track Approval of Medical Devices
MedTruth Editors · January 25, 2023
Due to the findings regarding medical device recalls, the 510(k) fast-track approval process is being put into question.
Research + FindingsPhilips Moves to Dismiss CPAP Lawsuits
MedTruth Editors · January 3, 2023
In June 2021, Philips recalled CPAP devices after it was discovered that the foam used to dampen the noises made by the machines were breaking down and emitting toxic gasses and particles.
Legal DevelopmentsNext Federal Bard Hernia Mesh Trial Delayed
MedTruth Editors · December 14, 2022
The third and fourth Bard hernia mesh trials will be delayed until later in 2023 for unknown reasons.
Legal DevelopmentsExactech Implant MDL Granted
MedTruth Editors · November 4, 2022
The medical devices involved in the lawsuits are used in ankle, hip and knee replacement surgeries.
Legal DevelopmentsFDA Approves New Aid For Stroke Survivors
MedTruth Editors · September 29, 2022
A new device for stroke survivors with dysphagia has been certified safe to use and will be available for doctors to use in stroke treatment.
FDA RegulationMedtronic Recalls Obstructed Airway Tubes
MedTruth Editors · September 22, 2022
Endotracheal tubes are medical devices used during surgery to provide an airway for patients to breathe. A number of Medtronic models may become obstructed during use.
FDA RegulationFDA Approves OTC Hearing Aid Rules
MedTruth Editors · September 1, 2022
The ruling establishes a new category of hearing aids designed to be sold over the counter to adults with mild to moderate hearing impairment.
FDA Regulation40,000 Hip Implants Added to 2021 Exactech Recall
MedTruth Editors · August 26, 2022
The hip implants have been recalled due to oxygen exposure that can degrade the polyethylene liners in the implants.
NewsVaginal Mesh Suit Summarily Dismissed
MedTruth Editors · August 4, 2022
A summary judgment can be thought of as a trial on paper. Both sides submit their best arguments for why the law favors their side, accepting all of their opponent's claims, with the judge eventually deciding the outcome.
Women's HealthFDA Recalls At-Home Ventilators
MedTruth Editors · July 14, 2022
The FDA has issued a Class I recall of Baxter Healthcare Corporation’s Volara systems after severe side effects were discovered.
FDA RegulationFDA Recalls Medtronic Heart Pump Kits
MedTruth Editors · June 16, 2022
Medtronic’s HVAD Pump Implant Kit is a type of medical device used to help the heart pump blood.
NewsPhilips Respironics Ventilator Faces Second Recall
MedTruth Editors · June 14, 2022
The recall addresses the defect that causes these ventilators to completely shut down without prior warning.
FDA RegulationFDA Releases Philips Recall FAQ
MedTruth Editors · May 30, 2022
The guide helps to determine if a Philips Respironics machine was recalled and what the risks are of using these recalled devices.
FDA RegulationFDA Issues Cybersecurity Guidance For Medical Devices
MedTruth Editors · April 21, 2022
Attacks from cybercriminals have rendered entire hospital networks powerless and have led to delays in diagnosis, delays in treatment, and increases in patient harm.
FDA RegulationFDA Recalls Ventilators For Adhesive Defect
MedTruth Editors · March 29, 2022
Philips Respironics’ ventilators could stop functioning without warning or notification, potentially leading to patient deaths.
FDA RegulationFDA Orders Phillips To Issue CPAP Warnings
MedTruth Editors · March 22, 2022
Some Philips CPAP and BiPAP machines use a foam that may break down and cause serious injury.
FDA RegulationSmith & Nephew Hip Implant MDL Claims Reduced
MedTruth Editors · March 18, 2022
Plaintiffs in the MDL all underwent hip resurfacing surgery with metal-on-metal implants.
Legal DevelopmentsCook Medical IVC Filter Litigation Makes History in Indiana
MedTruth Editors · March 11, 2022
Retrievable IVC filters should be removed, but many are left in the body, and can cause bodily damage and pain.
NewsFDA Requests Public Comment on Credibility of Medical Device Models
MedTruth Editors · February 17, 2022
The new guidance will be used to support medical devices in the submission processes for a number of FDA approvals and clearances.
FDA RegulationHernia Mesh Victims Move for MDL Consolidation
MedTruth Editors · February 11, 2022
Because the patients’ claims are nearly identical, it would be inefficient to have the same discovery processes repeated in multiple courts.
NewsFDA Releases Patient Feedback Guidance
MedTruth Editors · February 3, 2022
The goal of these new guidances is to give patients and advocates a voice in the medical device process.
FDA RegulationFDA Recalls Medtronic Atherectomy Device
MedTruth Editors · February 1, 2022
Medtronic’s atherectomy system is a medical device used in surgical procedures to clear plaque from the walls of arteries that obstruct blood flow.
NewsFDA Recalls Anesthesia Component
MedTruth Editors · January 27, 2022
A flow anesthesia system provides inhaled anesthesia and controls the ventilation of patients with limited abilities to breathe.
NewsFDA Releases Device Guidance Strategies For Women
MedTruth Editors · January 21, 2022
The CDRH Health of Women program aims to address the sex and gender disparity in medicine by including women in research and working to better understand their issues.
Women's HealthFDA Recalls Medtronic Ventilators After Complaints and Death
MedTruth Editors · January 13, 2022
The ventilators have an error that can cause the devices to stop working as intended and become inoperable, which can lead to neurological injury and, if left unchecked, death.
FDA RegulationFDA Warns Medtronic Over Faulty Insulin Pumps
MedTruth Editors · January 11, 2022
In an inspection of Medtronic’s firm, the FDA found four major failures in the facility’s insulin pump manufacturing practices.
FDA RegulationPhilips Faces Class Action Suit Over Recalled Sleep Apnea Device
MedTruth Editors · November 8, 2021
Philips' CPAP machine was recalled in June over concerns that users could be exposed to polyester foam.
Legal DevelopmentsThe 510(k) Approval Process: A Guide
MedTruth Editors · October 19, 2021
Manufacturers can use the 510(k) process as long as their new medical device is appropriately similar to a device that has already been approved.
FDA RegulationBoston Scientific Recalls Pacemakers
MedTruth Editors · August 31, 2021
Boston Scientific has recalled a line of pacemakers in a Class I recall, which is issued for products which could cause serious injury or death.
NewsScottish Vaginal Mesh Victims Sent to the U.S.
MedTruth Editors · July 22, 2021
Scotland has agreed to pay for Scottish women implanted with vaginal mesh to travel to the United States and undergo treatment from a specialist.
Women's HealthPelvic Mesh Lawsuit Amendment Struck Down by Penn. Court
MedTruth Editors · July 14, 2021
Judge Wiegand has rejected the amended complaint of Susan and Carl Antonucci in an ongoing lawsuit regarding Boston Scientific’s pelvic mesh products.
Legal DevelopmentsJohnson & Johnson Pelvic Mesh Lawsuit Moves Forward Despite Lack of Details
Carah Wertheimer · May 14, 2021
A judge has decided that Theresa Drumheller does not need to provide more details about her pelvic mesh for the lawsuit to proceed.
Legal DevelopmentsTwo Brands of Mesh Linked to Greater Risk of Breast Surgery Complications
Carah Wertheimer · April 7, 2021
According to the FDA, two brands of surgical mesh used in breast reconstruction surgery may be linked to a higher risk of complications.
Women's HealthMulti-Million Dollar Transvaginal Mesh Settlement with 47 States
MedTruth Editors · March 31, 2021
Boston Scientific has agreed to settle transvaginal mesh claims from 47 states and the District of Columbia for $188.7 million. Last week’s settlement concludes a series of lawsuits accusing Boston Scientific of violating consumer protection laws by misrepresenting the safety and effectiveness of their transvaginal mesh products.
Legal DevelopmentsNew Guide Teaches Consumers How to Verify FDA Approved Medical Products
MedTruth Editors · March 18, 2021
Following an increase in fake “FDA Registration Certificates,” the FDA published an online consumer guide to medical device approval.
FDA RegulationParagard Video Ad Fails to Mention Risks, FDA Warns Manufacturer
Carah Wertheimer · March 12, 2021
The FDA has warned Paragard IUD manufacturer CooperSurgical for running ads that fail to disclose Paragard’s safety risks.
Women's HealthFDA Acts to Protect Consumers from Fake "FDA Certified" Health Care Products
James Parker · March 9, 2021
The FDA sent letters to 25 printing firms to stop producing fake “FDA registration certificates.”
FDA RegulationParagard IUD Lawsuits Transferred to Female Judge in Georgia
Carah Wertheimer · January 26, 2021
Paragard copper IUD lawsuits filed by women from 23 states were grouped together and transferred to federal court in Atlanta late last year.
Legal DevelopmentsFibroid Removal Safety Recommendations Updated by FDA
Carah Wertheimer · January 7, 2021
The FDA has finalized safety recommendations for the use of power morcellators in surgeries to remove fibroids.
FDA RegulationParagard IUD Lawsuits Best Handled by Female Judge, Attorney Says
Carah Wertheimer · December 8, 2020
A personal injury lawyer representing Paragard IUD clients suggested a female judge be assigned a pending Paragard class action lawsuit.
Women's HealthFDA Recommends Black Box Warning on Breast Implants
James Parker · October 2, 2020
The FDA has issued a final warning label and new guidance to inform patients of the potential risks associated with breast implants.
Women's HealthParagard Lawsuit Claims Copper IUD Broke in Uterus
MedTruth Editors · September 3, 2020
A woman is suing the maker of the Paragard intrauterine device after part of the copper IUD broke off in her uterus during removal.
Women's HealthDental Implant Complications: Dick Van Dyke's Painful Story
Akilah Wise · September 2, 2020
Dick Van Dyke experienced excruciating headaches, chronic fatigue and insomnia despite tests coming back normal. He turned to Twitter for answers.
Health FeaturesEssure Settlement Costs Bayer $1.6 Billion
MedTruth Editors · August 20, 2020
Bayer will pay $1.6 billion to settle the majority of U.S. claims brought by women who said they were sickened or harmed by Essure permanent birth control.
Legal DevelopmentsToxic Metal Elements Potentially Linked to Essure Side Effects
T.J. La · August 12, 2020
A French study found metal particles in the bodies of women with Essure implants, which may be due to corrosion of the device.
Women's HealthEssure Linked to Heavy Periods and Chronic Pelvic Pain
T.J. La · August 11, 2020
Women implanted with the Essure sterilization device reported experiencing heavier periods and more pelvic or abdominal pain than patients who’d had their tubes tied, according to new data from the device-maker Bayer.
Women's HealthIs It Time to Recognize Breast Implant Illness as a Medical Condition?
Lauren Styx · August 6, 2020
A petition sponsored by the Breast Implant Safety Alliance is calling for the CDC and FDA to develop a medical code for breast implant illness.
Health FeaturesAdverse Event Reporting Resumes After COVID Hiatus
James Parker · June 24, 2020
The slowdown in adverse event reporting can be attributed to an official regulatory pause for a period of two months.
FDA RegulationCME Pump Recall Initiated For Inaccurate Medication Dispensing
James Parker · April 13, 2020
CME America’s BodyGuard Infusion Pump Systems have been recalled due to potentially fatal defects in medication dispersal.
FDA RegulationFDA Pipeline Recall Initiated to Protect Aneurysm Patients
James Parker · April 9, 2020
The FDA has recalled Medtronic's Pipeline Flex Embolization products after the organization discovered that the device could fracture during or after placement.
FDA RegulationMedical Device Removal Surgeries Delayed by Coronavirus Pandemic
Nicole Knight · March 26, 2020
Patients who have been implanted with medical devices face uncertainty over when they can have an unwanted device removed or receive treatment for device-related complications.
NewsHundreds of Thousands of Medtronic Insulin Pumps Recalled
Kimberly Nicoletti · March 6, 2020
Medtronic has recalled about 322,000 defective insulin pumps used by type 1 diabetics. The pumps from the MiniMed 600 series can deliver too much or too little insulin due to missing or broken retainer rings.
FDA RegulationFDA Bans Electrical Stimulation Devices After Identifying Substantial Risk
James Parker · March 5, 2020
The FDA has banned electrical stimulation devices, used for self-injurious or aggressive behavior, due to significant psychological and physical risks.
FDA RegulationFDA's New Policy Loosens Medical Device Approval Process
Nicole Knight · February 18, 2020
The FDA has exempted more than 200 types of medical devices and testing products from safety and effectiveness reviews after a new policy went into effect Dec. 30.
FDA RegulationFDA Updates Recognized Consensus Standards for Medical Devices
Benjamin Duong · January 28, 2020
The FDA published more than 80 additions, withdrawals or modifications to its list of recognized consensus standards for medical devices in the U.S. market, impacting devices such as cardiovascular stents and nails used to secure implants to bones.
FDA RegulationEthicon Stapler Recall Removes Over 90,000 Units From Circulation
James Parker · January 27, 2020
The FDA is enforcing an Ethicon stapler recall after units were ejecting malformed staples.
FDA RegulationiPap: The Emerging Future of Cervical Cancer Screening Technology
Tess Francke · January 21, 2020
A new, at-home cervical cancer screening test may just revolutionize early detection, especially in international markets that lack the infrastructure to provide easy access to doctors and regular pap smear tests.
Women's Health2020 Kicks Off With Global End of Controversial Birth Control Essure
Carah Wertheimer · January 7, 2020
Controversial birth control Essure finally removed from the market, bringing celebratory remarks from the harmed patients who call themselves the "E-sisters."
NewsEthylene Oxide and Concerns With Medical Device Sterilization
Nicole Knight · January 6, 2020
Ethylene oxide, a gas used to sterilize more than half of medical devices in the U.S., can cause cancer. As agencies begin to regulate the gas, hospitals may face potential medical device shortages due to the lack of an acceptable sterilization alternative.
FDA RegulationFDA Approves First Single-Use, Disposable Duodenoscope
James Parker · January 6, 2020
The Exalt Model D, manufactured by Boston Scientific, is the first single-use duodenoscope approved for physicians.
FDA RegulationICIJ Report Shows More Women Injured by Medical Devices
Nicole Knight · December 12, 2019
An ICIJ analysis of the MAUDE database found more women filed medical device-related injury reports than men.
Research + FindingsRobotic Hernia Surgeries Cost More, But Are They Better?
S. Nicole Lane · December 11, 2019
Free hernia screenings may be used as an opportunity to show patients the da Vinci surgical robot, but concerns about the benefits and safety of robotic surgery remain.
Health FeaturesHealth Canada Introduces Medical Devices Directorate
Benjamin Duong · December 10, 2019
The MDD will allow Health Canada to better regulate medical device technology during its entire lifecycle — from research and development to use by patients and providers.
FDA RegulationFDA Panel Reveals: Not All Medical Devices Created Equal
Crystal Duan · December 6, 2019
The FDA hosted a public advisory committee meeting to discuss the adverse health impacts of metals in medical devices, such as dental amalgam, Paragard contraceptives and hip implants.
FDA RegulationIs Your Doctor Under the Influence of Industry Money?
Nicole Knight · December 4, 2019
Dollars for Docs, a free ProPublica database, allows patients to find out whether their healthcare provider has taken payments from drugmakers or device makers — including money for meals, gifts, travel, consulting, research activities and speaking fees.
Health FeaturesFormer FDA Adviser Draws Attention to Complications With LASIK
Emma Schkloven · November 22, 2019
Dr. Morris Waxler, a retired Food and Drug Administration advisor who voted to approve LASIK in the 1990s, is now calling for the medical device to be removed from the market.
NewsFDA Encourages Use of Disposable Duodenoscopes
Tess Francke · November 18, 2019
Traditional duodenoscopes may cause infection. The FDA recommends hospitals transition to disposable duodenoscopes and warns against illegal ATP test strips used to determine cleanliness.
FDA RegulationDoctor and Accomplice Charged in Transvaginal Mesh Surgery Scheme
Nicole Knight · November 14, 2019
A doctor and his consultant face multiple charges after tricking transvaginal mesh patients into getting unnecessary surgery.
Legal DevelopmentsFDA Recommends Black Box Warnings on Breast Implants
Carah Wertheimer · October 24, 2019
The FDA has just released a 21-page document articulating the risks and benefits associated with breast implants to ensure that all consumers have access to "complete information" on the medical devices. This is the agency’s first update to breast implant consumer information practices since 2006. All members of the public and professionals of the medical world are invited to comment within the next 60 days for any revisions to the draft before the document is finalized.
FDA RegulationRiegel v. Medtronic: How the Landmark Case Limits Patient Rights
Carah Wertheimer · October 17, 2019
In 2008, a complex case set a legal precedent that dictates how Class III medical devices are approached. It's the landmark Supreme Court ruling, known as Riegel v. Medtronic, that changed everything. Now, those harmed by Class III medical devices struggle to seek legal recourse.
Legal DevelopmentsMarketing Tactics Mislead Consumers, Says Latest Testimony Against J&J Mesh
James Parker · July 31, 2019
In the latest transvaginal mesh trial, led by California Attorney General Xavier Becerra, expert testimony speaks to the way Johnson & Johnson's advertisements mislead consumers. Surgeon Margolis believes their mesh causes "substantial, significant, irreversible damage," despite consumer-friendly ads.
Legal DevelopmentsCobalt Toxicity: The Poison in Her Hip Replacement
S. Nicole Lane · June 28, 2019
Frances was 39 when she had cobalt alloy hips implanted. Within weeks, her skin broke out in boils. Within months, she faced effects ranging from memory loss and visual disturbances to severe tinnitus and PTSD-like rage/anxiety attacks. The effects of cobalt toxicity on the brain are evident.
Patient StoriesStories Not Statistics: Faces of Transvaginal Mesh
Carah Wertheimer · May 31, 2019
For Pelvic Pain Awareness Month, MedTruth is sharing patient stories. We're recognizing two transvaginal mesh survivors living with chronic pain. For Billie Copley, 44, and Jennifer Snowden, 34, transvaginal mesh implants have changed their lives forever.
Patient StoriesFDA Stops Sales of Transvaginal Mesh
Carah Wertheimer · April 19, 2019
The FDA gave transvaginal mesh companies Boston Scientific and Coloplast 10 days to submit plans to withdraw their products from the market - officially ending transvaginal mesh sales. Unfortunately for many, the damage has been done.
FDA RegulationWhy You Should Care About the Medical Device Safety Act
Carah Wertheimer · April 17, 2019
Advocates and individuals harmed by Essure, mesh, breast implants and hip replacements are lobbying representatives to support the Medical Device Safety Act, a bill that would allow consumers to get justice from manufacturers for medical device injuries.
Health FeaturesWhat is Breast Implant Illness?
Lauren Styx · April 9, 2019
In the past 20 years, more women have been coming forward suffering from symptoms related to their breast implants. While doctors insist these ailments are caused by other health issues, victims of breast implant illness take a stand to share their truth.
Patient StoriesEssure Birth Control May Result in Unplanned Pregnancy, Birth Injuries
Nicole Knight · October 5, 2018
An unknown number of women who had the permanent birth control implant Essure still became pregnant—in some cases, resulting in miscarriage or birth injuries.
Women's HealthEssure Still Sold to U.S. Women Through 2018, Despite Risks
S. Nicole Lane · September 13, 2018
Even though the device is no longer selling in other countries, Bayer, its manufacturer, will continue to offer Essure to women in the U.S.
Health Features5 Signs You Have Hernia Mesh Complications
Ashley Lombardo · April 25, 2018
More than one million hernia repairs are performed each year. After a hernia mesh surgery, a non-healing wound may develop and the following surgeries could require longer recovery times. Here's how to identify the most common hernia mesh complications.
Health FeaturesNew Procedure May Become A Hip Replacement Alternative
Ashley Lombardo · January 22, 2018
A necessary advancement in hip surgery is being performed in an Ohio hospital, with hopes it will ease the burden of hip implant risks by offering a hip replacement alternative.
NewsMorcellator Use Declines Following FDA Warning
Ashley Lombardo · January 17, 2018
The FDA has affirmed a four-year-old warning over the risk of developing uterine sarcoma after undergoing surgery with morcellation.
FDA RegulationNewly Discovered Gene May Help Metal-on-Metal Hip Patients
Ashley Lombardo · January 10, 2018
An incredible discovery in Australia could change the way we approach metal-on-metal hip replacement procedures to better protect patients from metal poisoning.
Research + FindingsNew Zealand Fully Bans Transvaginal Mesh
Ashley Lombardo · January 10, 2018
New Zealand's staunch health advocacy has led to a full vaginal mesh ban and continued efforts to improve medical device safety for women.
NewsThe Truth About Hernia Mesh
Ashley Lombardo · October 18, 2017
More than one million hernias occur each year. Hernia mesh, a common treatment device, may cause serious complications.
Health FeaturesCould These New Bills Improve Medical Device Safety?
Ashley Lombardo · May 28, 2016
Congressman Mike Fitzpatrick proposes two bills, Ariel Grace's Law and the Medical Device Guardians Act, to improve regulations for medical device safety based on injuries related to Essure and power morcellators.
Laws + Congress