Highmark First Insurer to End Uterine Morcellation Coverage
Highmark Inc., one of the nation’s largest insurance companies, announced over the weekend that it will no longer cover laparoscopic uterine surgeries that involve the use of the a power morcellator. The company is the first to announce such a … Continue reading
First Trial in Federal Mirena Litigation Scheduled to Begin in March 2016
The federal judge overseeing a Mirena litigation in the Southern District of New York has scheduled its first trial to begin in March 2016, court records indicate. According to a scheduling order on July 29th, the proceeding’s first trial has … Continue reading
J&J Issues ‘Worldwide Market Withdrawal’ of Power Morcellator Products
Johnson & Johnson has started taking all its power morcellator products off the market, and is asking doctors to promptly return devices they bought before the company’s sale suspension in April, according to the Washington Post. Johnson & Johnson announced … Continue reading
Doctor Asks FDA to Investigate Program that Approved Power Morcellator Surgery
An FDA committee’s failure to agree on whether power morcellator use should be banned in the U.S. has prompted a doctor to ask for further investigation into the agency’s process for approving medical devices, according to recent reports. The written … Continue reading
Testosterone Class Action in Canada Claims Delatestryl Can Cause Serious Heart Events
A class action lawsuit launched in Canada claims that the manufacturer of Delatestryl, a prescription testosterone treatment, failed to warn doctors and patients about its association with serious cardiovascular side effects. The complaint, which was filed in the Ontario Superior … Continue reading
5,500 Lawsuits Now Filed over GranuFlo, NaturaLyte in Mass. Litigations
A dialysis drug and service provider is currently “fending off a tidal wave of lawsuits” on behalf of GranuFlo patients who allegedly sustained strokes, heart attacks and other injuries that may have caused sudden cardiac death, the Boston Herald reports. Between … Continue reading
FDA Rejects Testosterone Black Box Warning, Schedules Advisory Committee Meeting to Discuss Heart Risks
U.S. health regulators have rejected a petition seeking a so-called black box warning to alert patients of potential cardiovascular risks associated with AndroGel and other low testosterone therapy medications. However, the Food & Drug Administration (FDA) will convene a meeting … Continue reading
Petition to Ban Power Morcellator Surgery Garners 12,700 Signatures by Mid-July
More than 12,700 people have voted to ban power morcellator surgery in the U.S., by way of a petition that warns of its potential to spread uterine sarcoma and other cancers throughout the abdominal cavity. According to the Change.org petition’s … Continue reading
Testosterone Treatments Raise Concern in Canada, Regulators Warn Men about Heart Risks
Testosterone treatments now blamed for serious heart and blood vessel problems in men have now been flagged for danger in Canada, where regulators have warned the public about these side effects, according to CBC News. A statement issued July 15th … Continue reading
FDA Advisors Say Morcellator Cancer Risk Can’t Be Fully Eliminated
A panel of advisors convened by the U.S. Food & Drug Administration (FDA) agreed on Friday that there is probably no way to completely eliminate the risk that a power morcellator might spread undetected uterine cancer cells during minimally-invasive gynecological … Continue reading
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