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Medical Devices

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.

News
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."

News
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 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 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.

News
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.

News
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
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.

News
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
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