Media Reports

NPR: Why People Do Bad Things

May 1st, 2012 | By
NPR: Why People Do Bad Things

May 1, 2012 ~ National Public Radio ran a podcast of an interesting topic, Why People do Bad Things. We often find that executives within a company or within a huge hospital complex will do things which most people find morally and ethically wrong. Listen to the story of Toby Groves, who as a young
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New J & J CEO Plans to Expand Medical Device Industry

Apr 30th, 2012 | By
New J & J CEO Plans to Expand Medical Device Industry

  It will be interesting to watch how Alex Gorsky, 51, handles his new job and all that comes with it. As of April 26, he is in charge of Johnson & Johnson (J&J) as its Chief Executive Officer. He also inherited a massive number of lawsuits from surgical mesh and defective metal hip devices.
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The Future of Mesh Sales is Rosy Says Market Research Group

Apr 26th, 2012 | By
The Future of Mesh Sales is Rosy Says Market Research Group

April 24, 2012 ~ Even though the number of lawsuits against synthetic mesh manufacturers is growing by the day, surgical mesh products are expected to surge in sales in 2012, according to the Millennium Research Group (MRG). The group interviewed 181 U.S. surgeons (gynecologists, urologists and urogynecologists) in November and December of last year. Among
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Consumer Reports: Dangerous Medical Devices

Apr 2nd, 2012 | By
Consumer Reports: Dangerous Medical Devices

April 1, 2012 ~ The May issue of Consumer Reports (here)  features an investigation into synthetic mesh and artificial hips – medical devices that escape rigorous testing to assure safety. Tens of millions of Americans are living with medical devices and whether a defibrillator, artificial hip or surgical mesh, – 90 percent of those devices
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Breaking News ~ J & J Sold Vaginal Mesh Implant Without FDA Approval

Mar 21st, 2012 | By
Breaking News ~ J & J Sold Vaginal Mesh Implant Without FDA Approval

March 21 ~ Bloomberg is reporting (here) that major medical device maker Johnson & Johnson (J&J) sold the Gynecare Prolift surgical mesh for three years before it was approved by the U.S. Food and Drug Administration (FDA). The mesh is now the subject of more than 550 lawsuits, reports Bloomberg. Prolift is a pre-cut mesh
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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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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.