Tag Archives: Essure

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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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Three Injured, Long Island Railroad Train Hits Car on Tracks

Three Injured When Long Island Railroad Train Hits Car on Tracks

Three people, including a train engineer, were injured on Wednesday when a Long Island Rail Road train hit a livery cab on the tracks west of Wyandanch station, LIRR officials said. LIRR spokesman Salvatore Arena said the driver of the Lincoln Town Car was taken to Good Samaritan Hospital Medical Center ...

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System for Tracking Prescription Drug Side Effects Flawed

Study Finds System for Tracking Prescription Drug Side Effects Flawed

System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.

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Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

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Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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Boston Scientific Transvaginal Mesh

Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries

More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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Iowa Couple Files Lawsuit over Essure Birth Control System Injuries

Couple Files Suit over Essure Birth Control System Injuries

Bayer Health Care faces a new lawsuit alleging injuries from the Essure permanent birth control system. In their lawsuit, an Iowa couple alleges that the wife suffered serious injuries as a result of the birth control device, Top Class Actions … Continue reading

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Bayer Faces Thousands of Essure Lawsuits

Bayer Faces Thousands of Essure Lawsuits

Thousands of women have filed lawsuits against Bayer alleging that Essure, the permanent birth control device, caused complications. The device has gained more attention in light of complaints from numerous women, many of whom took to social media to express … Continue reading

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Illinois Woman Alleges Essure Complications Led to Removal of Uterus, Fallopian Tubes

Essure Issues Led to Removal of Uterus, Fallopian Tubes

Another lawsuit has been filed against Bayer over Essure, the permanent birth control device for women. An Illinois woman alleges that Essure implantation led to serious complications, ultimately leading to the removal of her uterus and fallopian tubes. Essure consists … Continue reading

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Essure Litigation Underway, as Court Ruling May Hold Bayer Liable

Essure Suit Underway, as Court Ruling May Hold Bayer Liable

Bayer is facing a number of lawsuits alleging that the permanent birth control device Essure led to injuries such as pain, bleeding and device migration. A group of 98 women recently filed a lawsuit in Missouri and over 200 lawsuits … Continue reading

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Premarket Approval for Essure Birth Control Device Was Fraudulent, Patients Say

premarket-approval-Essure

Patients involved in the clinical trials conducted in connection with the premarket approval application (PMA) for the Essure birth control device say that patient records were altered to show favorable results despite patient reports of problems. The Food and Drug … Continue reading

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Legislation Introduced to Require FDA to Pull Essure Birth Control from Market

FDA to Pull Essure Birth Control from Market

U.S. Representative Michael Fitzpatrick of Pennsylvania has introduced a new bill that directs the Food and Drug Administration (FDA) to withdraw Bayer’s Essure birth control implant from the market. The safety of the implantable device—a permanent birth control method—has been … Continue reading

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Pennsylvania Congressman Proposes Legislation to Revoke FDA Approval for Essure Birth Control System

Pennsylvania Congressman Mike Fitzpatrick plans to introduce legislation to revoke the approval the Food and Drug Administration (FDA) granted to the Essure birth control system in 2002. The bill calls for withdrawing Essure’s approval within 60 days, ABC station WRIC … Continue reading

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Essure Study Raises Safety Concerns

Essure Study Raises Safety Concerns

A study published in the British Medical Journal lends support to claims some women have made about the safety of Essure, Bayer’s permanent birth control device. The study, which was led by Dr. Art Sedrakyan of Weill Cornell Medicine in … Continue reading

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FDA Panel Urges Label Changes, Better Guidance for Birth Control Device

FDA Panel Urges Essure device Label Changes

A Food and Drug Administration (FDA) advisory panel has recommended that the label for the Essure birth control device clearly state that Essure is a surgical device and the implant should come with more comprehensive instructions for insertion and follow-up … Continue reading

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After Learning that Essure Meeting Coincides with Papal Visit, Essure Advocates Criticize FDA

Essure Advocates Criticize FDA

Advocates for women who say they suffered injuries related to the permanent birth control device Essure say that the U.S. Food and Drug Administration (FDA) intentionally scheduled a panel meeting the same day as Pope Francis’ first-ever papal address. The … Continue reading

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