Category Archives: Essure

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Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Cancer Groups Call for E-cigarettes Regulation/Research

Two-Leading-Cancer-Groups-Issue-Call-for-Regulation-of-E-cigarettes-and-Research-on-Health-Risks

The American Society of Clinical Oncology & the American Association for Cancer Research called for government regulation & research of e-cigarettes on health effects.

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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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Fracking Releasing Hazardous Chemicals into Local Waterways

Fracking Releasing Hazardous Chemicals into Local Waterways

Study shows two hazardous chemicals—ammonium & iodide—are being released & spilled into Pennsylvania and W.Virginia waterways from fracking operations in Marcellus shale.

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FDA Urged to Ban Powdered Caffeine

FDA Urged to Ban Powdered Caffeine

Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.

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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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Two Men Found Dead of Carbon Monoxide Poisoning

Two Men Found Dead of Carbon Monoxide Poisoning at Long Island, New York Auto Shop

Two men were found dead of apparent carbon monoxide poisoning in a Holbrook, New York, auto-detailing shop Thursday night, Suffolk County police say.

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Louisiana Whistleblower Lawsuit Revived

Louisiana Whistleblower Lawsuit Revived

A state appeals court in Louisiana has ruled that a former employee of Rapides Parish Coliseum can proceed with a whistleblower lawsuit against the Coliseum Authority.

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Essure Plaintiffs Ask to Move Lawsuit to Federal Court

A group of women has filed a lawsuit against Bayer HealthCare over adverse effects of the Essure birth control system. Twenty-eight women filed the lawsuit together on March 21, 2017. Each woman alleges she suffered adverse health effects as a … Continue reading

Posted in Defective Medical Devices, Essure, Legal News |

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

Posted in Defective Medical Devices, Essure, Health Concerns | Tagged , , , , |

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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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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Power Morcellators, Essure Birth Control System Prompt Introduction of Two Proposed Bills to Protect Consumers

House legislation has recently been introduced in an effort to prompt quicker action by federal regulators to remove dangerous medical devices from the market. Two bipartisan bills are expected to ease the process for patients who have suffered due to … Continue reading

Posted in Defective Medical Devices, Essure, Legal News, Product Recalls, Recalled Medical Devices |

New Study Says Essure Approval May Have Had Insufficient Safety Data

According to a just-published study, the Essure birth control implant may have received initial Food and Drug Administration (FDA) approval based on insufficient or flawed data. The FDA approved the Essure non-surgical permanent birth control device in 2002, but since … Continue reading

Posted in Defective Medical Devices, Essure |

FDA Mandates New Clinical Study and Boxed Warnings for Essure Birth Control Device

On February 29, 2016 the Food and Drug Administration (FDA) announced the actions it would take to address the risks associated with Essure permanent birth control device. A news release on the FDA website indicates that the FDA ordered Bayer, … Continue reading

Posted in Defective Medical Devices, Essure, Health Concerns |

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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FDA to Announce Essure Review Decision in February

FDA-Essure-Decision

The U.S. Food and Drug Administration (FDA) has said it will announce its decision about what action it will take on Bayer’s permanent birth control device Essure in February 2016. The FDA decision will be based on information gathered by the … Continue reading

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Update on FDA Evaluation of the Safety of Essure Birth Control System

FDA Evaluation of the Safety of Essure Birth Control System

The Food and Drug Administration (FDA)’s Office of Women’s Health has issued an update on the agency’s evaluation of the safety of the Essure birth control system. Essure—a form of permanent birth control (female sterilization)—is under FDA review in response … Continue reading

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