Product News and Recalls

Critics: EU medical device plan falls short

European Union officials are considering more stringent regulations for medical devices. But according to a report on MedPage Today, some European health advocates complain that the proposed regulations wouldn’t go far enough.

The report quotes Andrew Boulton, MD, president of the European Association for the Study of Diabetes, as saying: “We feel the proposals are a step in the right direction but we need many more steps to address patient safety.”

The ...

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Concerns about FDA fast-track process

A story in The Scientist magazine says some medical professionals are concerned about health risks attendant with the U.S. Food and Drug Administration’s heavy reliance on the fast-track review process for new medications.

The Scientist cites an article in the Journal of the American Medical Association, which states that the FDA fast-tracked nearly half of all the 35 drugs it reviewed in 2011.

Among them was the blood thinner dabigatran, sold ...

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Workers linked to meningitis outbreak had concerns about quality

Former workers at a company with ties to the pharmacy responsible for a deadly meningitis outbreak said they had safety concerns.

An article in the New York Times includes interviews with former employees from Ameridose, a drug manufacturing company that has many of the same owners as the New England Compounding Center – the source of the contaminated steroid medication that has so far killed 15 people.

“Six former employees, five from Ameridose and one from New England Compounding, described a corporate ...

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Man describes recovery from brain injury

The San Francisco Chronicle has printed a column by Karl Weisgraber, a 71-year-old man who suffered a traumatic brain injury after he fell off a ladder while doing work on his house and hit his head on a rock.

Weisgraber is a retired biochemist who worked on cardiovascular and Alzheimer’s research at the Gladstone Institutes in San Francisco. He spent three weeks in a coma and, through therapy, had to relearn how to walk, read and write.

An introduction to Weisgraber’s column ...

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Mesh implants prompt class action suit in Australia

The Australian Broadcasting Corporation reports on a class action lawsuit that Johnson & Johnson faces in Australia over the company’s transvaginal mesh implants.

According to the report, the mesh devices have caused “life-changing harm” for a significant number of the women who received them because of their tendency to erode in patients’ bodies.

The implants are sling-like devices designed to treat urinary incontinence and pelvic organ prolapse, which ...

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FDA warns of more drugs in meningitis outbreak

The U.S. Food and Drug Administration has expanded the list of potentially contaminated drugs from the Massachusetts-based New England Compounding Center – including another type of steroid and drugs used for heart and eye surgery.

An injectable steroid from the NECC called methylprednisolone acetate has already been linked with a deadly fungal meningitis outbreak.

On Oct. 15, the FDA issued the following warning: “As a result of the ongoing investigation of NECC, ...

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