Media Reports

Consumer Reports Campaign email Alerts Million About Defective Medical Devices

Mar 13th, 2012 | By
Consumer Reports Campaign email Alerts Million About Defective Medical Devices

MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes they are very bad. The president of the 76-year-old publication wrote in an email to 1 million subscribers this year that, “The implant that fixed your knee or your heart may
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Metal Hip Device Implant Sold in EU After Rejected in U.S.

Feb 15th, 2012 | By
Metal Hip Device Implant Sold in EU After Rejected in U.S.

February 15, 2012 ~ Barry Meier of the New York Times reports that Johnson & Johnson’s DePuy division continued to sell a defective artificial hip overseas even after it was rejected for sale in the U.S. Two related versions of the metal-on-metal hip, DePuy ASR were implanted in about 93,000 patients worldwide with about one-third
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Hernia from Hell Treated with Biologic Mesh

Feb 7th, 2012 | By
Hernia from Hell Treated with Biologic Mesh

February 6, 2012 ~ James Fico had a problem. The Sarasota Herald-Tribune (here) reports on the North Port man’s basketball-size hernia that protruded from his belly for more than five years. (Caution- the photos in this article are not for the weak of heart). Unfortunately for Fico, 62, he had had a major heart attack
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Medical Device Makers Will Double Fees for Faster FDA Reviews

Feb 1st, 2012 | By
Medical Device Makers Will Double Fees for Faster FDA Reviews

Medical device makers want to get their products into the marketplace faster. The U.S. Food and Drug Administration (FDA) needs more operating capital to review medical devices. The two have formed an informal agreement that was leaked to Bloomberg on Wednesday, February 1 (here). Under the proposed plan, medical device makers would pay $595 million
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Toys from China and Medical Devices Share Scrutiny in EU

Jan 27th, 2012 | By
Toys from China and Medical Devices Share Scrutiny in EU

Many in the United Kingdom assume that an implanted medical device is reviewed for safety before it is permanently placed inside a patient. They would be wrong. The Guardian reports (here) that the European quality standard – the CE mark – represents an assurance that is the same whether the product is a breast implant
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Showdown in House Hearings Over Mesh, Medical Devices

Jan 24th, 2012 | By
Showdown in House Hearings Over Mesh, Medical Devices

January 23, 2012 ~ House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelvic organ prolapse, and the Allergan Lap-Band for weight reduction because of a growing number of patient injuries and a fear that device makers and the U. S. Food and Drug Administration
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FDA Misses Deadline to File Financials for Review

Jan 24th, 2012 | By
FDA Misses Deadline to File Financials for Review

The U.S. Food and Drug Administration (FDA) was supposed to submit a new agreement to lawmakers on  January 15, concerning how much funding it will need next year to review medical devices and conduct product reviews. Bloomberg reports (here) no new agreement was filed – the FDA essentially missed its deadline. That may hurt the
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Covidien Recalls Surgical Staples After 3 Deaths

Jan 18th, 2012 | By
Covidien Recalls Surgical Staples After 3 Deaths

January 16, 2012 ~ Medscape Medical News (here) reports that medical device maker Covidien is voluntarily recalling surgical staples used in endoscopic thoracic surgery after three deaths were linked to the device. In addition to the three deaths, there were 13 serious injuries associated with the Duet TRS single-use cartridges which have the potential to
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FDA Orders Manufacturers to Study Mesh Complications

Jan 5th, 2012 | By
FDA Orders Manufacturers to Study Mesh Complications

JANUARY 4, 2012 ~ Bloomberg reports that the Food and Drug Administration’s division that oversees medical devices has ordered surgical mesh manufacturers to study how often synthetic mesh harms women by causing infection and organ damage. (story is here) The order follows an FDA report last summer of a five-fold jump in the number of
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Medtronic Pays $23 Million to Settle Doctor Kickback Charges

Dec 18th, 2011 | By
Medtronic Pays $23 Million to Settle Doctor Kickback Charges

Medtronic is the world’s top maker of medical devices and it didn’t get that way without help. The U.S. Department of Justice accused the Minnesota-based company of having friends in high places – Share this:



We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.