Category Archives: Essure

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Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda

A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...

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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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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects ...

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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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Transvaginal Mesh Lawsuit Trial

$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial

An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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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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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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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

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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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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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