bad medical devices blog

The FDA on October 20 sent a letter to healthcare practitioners warning about complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences.
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh […]

University of Minnesota Medical School is considering a new conflict-of-interest policy so strict that doctors wouldn’t even be able to accept Post-it Notes bearing a drug company’s logo, the Star Tribune reports. The far-reaching policy, which if enacted would be among the toughest in the nation, comes as congressional investigators and the U.S. Justice Department […]

A year after the big Medtronic defibrillator recall, only a few defective wires that connect defibrillators to hearts have been replaced, the Toledo Blade reports some Toledo cardiologists say.
Last October, Medtronic recalled its Sprint Fidelis lead, the wire connecting the implanted defibrillators to the heart, after four reports of death due to fracturing lead […]

The New York Times reports that heart doctors and makers of medical devices meeting for their annual Transcatheter Cardiovascular Therapeutics convention were made aware that two senators are asking tough questions about financial ties between the doctors and the companies.
The Times says lawmarkers Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of […]

Medtronic’s new drug-coated artery stent does not compare to that made by Johnson & Johnson, and based on a report, shares of the company dropped in trading this week.
The Medtronic stent has been linked to heart attacks in its patients, an adverse reaction not linked to a similar stent manufactured by J&J.
In a study of […]

A Chicago woman has filed a lawsuit against a surgeon for implanting a heart device without her consent.
In the court filing, according to Forbes, the surgeon was receiving royalties from the company whose device he installed.
Dr. Patrick McCarthy is being accused of implanting the Myxo ETlogix rings in Toni Vlahoulis without receiving her consent. The […]

The Wall Street Journal reports that eight medical companies are joining forces to launch a $100 million study to determine how best to protect heart patients from rare but dangerous clots after they are treated with artery-opening devices called stents. The four-year, 20,000-patient study is intended to determine whether stent patients can safely go off […]

Two new studies suggest that heart patients may be better off receiving fewer artery-opening stents. The devices too often are used indiscriminately, research shows.
The Wall Street Journal reports that these results from a study known as FAME were presented here at the annual Transcatheter Cardiovascular Therapeutics meeting of cardiologists and medical-device manufacturers. And those findings […]

The Food and Drug Administration has approved the latest version of Boston Scientific’s latest version of its popular, yet controversial, Taxus stent.
In 2006, the FDA cracked down on Boston Scientific about the growing reports of the drug-eluting stent, designed to replace the traditional bare metal stent in preventing artery clogging and closure.
The Taxus stent was […]

The Food and Drug Administration has approved the latest version of Boston Scientific’s latest version of its popular, yet controversial, Taxus stent.
In 2006, the FDA cracked down on Boston Scientific about the growing reports of the drug-eluting stent, designed to replace the traditional bare metal stent in preventing artery clogging and closure.
The Taxus stent was […]