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Medical Devices

A doctor placing a pulse oximeter on a dark skin-colored hand representing the racism bias in pulse oximeters.

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. 

Man with abdominal pain representing the hernia mesh bellwether trials.

Hernia 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 Developments
Paragard copper IUD representing the Paragard adverse events with growing litigation.

Paragard 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.

Women's Health
A woman on a CPAP machine representing the Philips CPAP settlement.

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 Developments
Woman with hands on her heart representing the Bard IVC filter lawsuits.

Bard 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 Developments
A doctor inserting a port catheter system representing the Bard PowerPort MDL.

Bard 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 Developments
Surgeons performing surgery with medical devices representing the Medtronic bribery scheme.

Medtronic 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.

Image of a catheter device representing the Bard PowerPort that may be fracturing and causing thousands of lawsuits.

Bard 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.

A doctor looking at X-rays of a hip implant representing the J&J metal-on-metal hip implants allegedly causing heavy metal poisoning

J&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.

A dentist and patient discussion about planned teeth treatment in dental clinic office representing AGGA dental device lawsuit.

Dental 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.

A person holding CPAP mask representing 2022 reports added to CPAP device communication.

Late 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 Regulation
Gastroenterologist setting up endoscope representing the FDA issuing warning letters for medical device reporting.

FDA 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 Regulation
Two researchers looking at data representing a study that found correlation between FDA fast-track system and future medical device recalls.

New 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 + Findings
Close up of senior patient woman hand holding CPAP mask representing the Philips CPAP lawsuits.

Philips 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 Developments
A lawyer writing on a paper during a trial representing the delayed federal Bard hernia mesh trials.

Next 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 Developments
An elderly woman holding her knee representing the Exactech implant MDL.

Exactech 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 Developments
Image of a man struggling to swallow representing the new device to help stroke survivors with dysphagia.

FDA 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 Regulation
An endotracheal tube used during surgery representing the Medtronic recall.

Medtronic 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 Regulation
A man wearing a hearing aid walking outside representing the FDA approval of over-the-counter hearing aids.

FDA 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 Regulation
Elderly woman holding hip in pain representing the hip implants added to Exactech recall.

40,000 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.

A lawyer writing case papers representing a vaginal mesh lawsuit summarily dismissed.

Vaginal 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 Health
A man at home using a ventilator similar to the ones recalled by the FDA.

FDA 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 Regulation
A doctor listening to a person's heart representing the Medtronic heart pump kit recall.

FDA 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.

A woman on a ventilator at a hospital representing the Philips Respironics ventilator recall.

Philips 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 Regulation
Woman sleeping with CPAP machine representing the FDA releasing Philips recall FAQ guide.

FDA 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 Regulation
Doctors looking at brain scan representing the FDA Cybersecurity Guidance For Medical Devices.

FDA 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 Regulation
Nurse using a ventilator machine representing the Philips ventilator recall for adhesive defect.

FDA 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 Regulation
A woman using a CPAP machine in the hospital representing the Philips CPAP foam recall.

FDA 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 Regulation
3-D illustration of a hip implant representing the hip replacement MDL.

Smith & 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 Developments
A judge using gavel in courtroom representing IVC filter litigation in Indiana.

Cook 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.

Image of a computer modeling lungs representing the FDA credibility of medical device models guidance.

FDA 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 Regulation
Image of a man with stomach pain in hospital bed representing hernia mesh victims moving for an MDL consolidation.

Hernia 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.

Image of an FDA sign representing new FDA patient feedback guidance.

FDA 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 Regulation
Illustration of an atherectomy device representing the Medtronic recall.

FDA 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.

Image of a patient under gas anesthesia representing the flow anesthesia recall.

FDA 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.

Image of a female doctor talking to a woman about test results representing the FDA's device guidance strategies for women.

FDA 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 Health
Image of a patient on a ventilator with nurses working on the device, representing the Medtronic recall.

FDA 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 Regulation
Image of a person using an insulin pump representing FDA warning Medtronic over faulty 600 series MiniMed insulin pump.

FDA 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 Regulation
Image of a CPAP machine representing the Philips recall.

Philips 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 Developments
Image of a doctor holding a breast implant representing the 510(k) approval process by the FDA.

The 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 Regulation
Image of a doctor holding a pacemaker representing Boston Scientific recalling pacemakers.

Boston 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.

Image of a Scottish flag representing Scottish vaginal mesh victims sent to the US.

Scottish 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 Health
Image of a lawyer representing the pelvic mesh lawsuit amendment struck down by Pennsylvania court.

Pelvic 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 Developments
Image of a woman holding her stomach representing the Florida J&J pelvic mesh case.

Johnson & 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 Developments
Image of a doctor telling patient about breast implant surgeries and mesh.

Two 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 Health
Image of lawyers shaking hands representing the 188 million pelvic mesh settlement.

Multi-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 Developments
Image of a doctor and an FDA official representing the FDA medical device approval process.

New 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 Regulation
Illustration of a uterus with Paragard copper IUD.

Paragard 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 Health
Image of a person signing FDA documents representing fraudulent medical device registration claims.

FDA 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 Regulation
Illustration of a Paragard copper IUD representing the lawsuits transferred to a female judge in Georgia.

Paragard 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 Developments
Image of a woman holding her stomach, representing fibroid surgery safety recommendations by the FDA.

Fibroid 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 Regulation
Image of a hand holding a Paragard copper IUD, representing the lawsuits.

Paragard 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 Health
Illustration of gloved hands holding breast implants that have a black box warning with the new FDA guidance.

FDA 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 Health
Image of a person holding a Paragard copper IUD in their palm.

Paragard 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 Health
Photo of Dick Van Dyke speaking at the 2017 Phoenix Comicon.

Dental 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 Features
Image of a uterus representing Bayer's Essure permanent birth control settlement.

Essure 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 Developments
Image of a woman holding her pelvic area in pain, due to toxic metals from Essure side effects.

Toxic 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 Health
Woman holding her stomach in pain due to Essure, linked to heavy periods and chronic pelvic pain.

Essure 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 Health
Image of a person's hands on breast implants, representing breast implant illness diagnostic code.

Is 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 Features
Person on laptop during FDA reporting hiatus.

Adverse 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 Regulation
Man attached to infusion therapy machine representing the CME Pump Recall.

CME 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 Regulation
Image of a brain scan of an aneurysm patient, representing the FDA Pipeline embolization recall.

FDA 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 Regulation
Image of empty hospital bed representing medical device removal surgeries halted by the Coronavirus pandemic

Medical 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.

Person with a Medtronic MiniMed 600 series insulin pump which was recalled by the FDA.

Hundreds 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 Regulation
Illustration of a head representing mental illness and the Electrical Stimulation Devices ban.

FDA 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 Regulation
FDA signing medical device approvals.

FDA'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 Regulation
A photo of a person typing in reference to the FDA's recognized consensus standards for medical devices.

FDA 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 Regulation
Doctor using a recalled Ethicon surgical stapler.

Ethicon 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 Regulation
A black and white photo of the tools in the OncoGenesis cervical cancer screening test which can be taken at home due to improving technology

iPap: 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 Health
Photo of women celebrating the removal of birth control Essure from the market.

2020 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."

A photo of sterilized vaginal speculum, a medical device that may be sterilized with ethylene oxide.

Ethylene 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 Regulation
A photo of a medical assistant holding a duodenoscope, representing the recent FDA approval for a disposable, single use endoscopy device.

FDA 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 Regulation
A young woman of color reads the ICIJ report that more woman have been harmed by medical devices than men.

ICIJ 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 + Findings
A patient being operated on by a robotic hernia surgery device.

Robotic 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 Features
A photo of a Canadian flag, representing Health Canada's Medical Device Directorate.

Health 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 Regulation
Photo of knee and hip implants which were discussed at an FDA Panel addressing metal-containing medical devices and dental amalgam implants.

FDA 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 Regulation
A photo of money and a stethoscope, representing ProPublica's Dollars for Docs database.

Is 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 Features
A close-up photo of a dark-skinned man with hazel eyes, representing the current focus on LASIK risk and safety.

Former 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.

A photo of an FDA-recommended disposable duodenoscope, prior to recommendations to use disposable duodenoscopes.

FDA 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 Regulation
Doctor charged in transvaginal mesh surgery scheme consulting with patient.

Doctor 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 Developments
A photo of a woman on her computer perusing FDA website after issuing Black Box Warnings on Breast Implants. 

FDA 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 Regulation
A photo of the Supreme Court to represent Riegel v. Medtronic case which set the precedent for lawsuits filed by patients harmed by Class III medical device.

Riegel 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 Developments
A photo of a mesh fence to resemble the latest transvaginal mesh trial where testimony stated that J&J Mesh Misleads Consumers with Marketing Tactics.

Marketing 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 Developments
Photo of Frances Scott, who suffered cobalt toxicity after hip implants, and other advocates of Medical Device Problems group while they lobbied at the Capitol for the Medical Device Safety Act.

Cobalt 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 Stories
A photo of Billie Copley next to a photo of Jennifer Snowden, two women injured by transvaginal mesh.

Stories 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 Stories
A photo of a woman with transvaginal mesh after news of Transvaginal Mesh Sales Halted by FDA.

FDA 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 Regulation
A photo of a rally protest where people take a stand for the Medical Device Safety Act.

Why 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 Features
A photo of a finger pointing to a breast implant as woman asks what is breast implant illness.

What 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 Stories
A photo of a pregnant woman holding her baby bump to demonstrate the way Essure Birth Control may lead to Unplanned Pregnancy.

Essure 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 Health
Photo of doctor talking to female patient about birth control while Essure sill sold in US despite risks.

Essure 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 Features
Toilet with plunger representing bowel problems after hernia mesh surgery

5 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 Features
A photo of a woman holding her hip in pain, considering undergoing hip subchondroplasty as a hip replacement alternative.

New 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.

A photo of a woman in a doctor's office, refusing power morcellator treatment for uterine fibrioids after the FDA warning.

Morcellator 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 Regulation
A photo of a young woman suffering from hip pain from a metal-on-metal hip implant.

Newly 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 + Findings
Young woman lying in fetal position

New 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.

A photo of a fence to resemble mesh to reflect how reported complications reveal unforeseen hernia mesh risks.

The 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 Features
A group of chairs representing Congress' work on Ariel Grace's Law and the Medical Device Guardians Act to improve medical device safety.

Could 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