Archive for March 2012

FDA Expert Panel to Assess Metal Hips

Mar 30th, 2012 | By
FDA Expert Panel to Assess Metal Hips

The FDA has scheduled a two-day expert panel review of metal-on-metal hips as concerns mount about patient injuries. The June 27-28 gathering (location yet to be announced) will include researchers, patients, doctors and scientists to decide whether or not the agency needs to do a better job protecting patients in light of the high complication
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Beverly Martiniano: Suffering in Silence and Waiting Until October

Mar 27th, 2012 | By
Beverly Martiniano: Suffering in Silence and Waiting Until October

October 1, 2012 is an important day for Beverly Martiniano. It’s her 65th birthday, yes. But it is also the day she qualifies for Medicare allowing her to take the first step to have several synthetic surgical meshes removed from her body that have plagued her life and health for several years. She tells MDND
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What to Understand Pre-mesh: Graphic Videos of Mesh Removal and Sling Incision Treatment

Mar 27th, 2012 | By
What to Understand Pre-mesh: Graphic Videos of Mesh Removal and Sling Incision Treatment

The Cleveland Clinic is renowned for some pretty innovative procedures and reputable doctors. Among them, Dr. Howard Goldman provides video demonstrates a “simple sling incision” which cuts a synthetic sling used to treat incontinence if the patient is having complications. Many doctors feel anything other than a complete extraction leaves behind the complications of synthetic
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Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

Mar 23rd, 2012 | By
Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

March 23, 2012 ~ This has not been a good week for Johnson & Johnson. First word that it sold the transvaginal surgical mesh, ProLift, without getting any sort of FDA approval in advance (see background story here). Now the New York Times (NYT) (here) is reporting that J&J began phasing out the DePuy defective
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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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Call to Action: Citizens Lend Support to Sound Devices Act

Mar 21st, 2012 | By
Call to Action: Citizens Lend Support to Sound Devices Act

March 23, 2012 ~ The SAFETY OF UNTESTED AND NEW DEVICES (SOUND DEVICES) ACT OF 2012 is a critical step to stop others from being harmed by untested, unsafe medical devices like synthetic surgical mesh, say patients harmed by synthetic surgical mesh. The Sound Devices Act, introduced by Rep. Edward Markey (D-MA)  will give the
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Politics Gives a Pass to Negligent Doctors, Drug and Device Makers

Mar 20th, 2012 | By
Politics Gives a Pass to Negligent Doctors, Drug and Device Makers

March 20, 2012 ~ The advocacy group, Public Citizen in a letter (here) to Congress issued Monday, March 19 calls on the U.S. House to Reject the medical liability bill called H.R. 5. The House may vote this week on the legislation called the Help Efficient, Accessible, Low-Cost, Timely Healthcare Act. It essentially shields the
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Sick of Suffering in Silence

Mar 19th, 2012 | By

MARCH 19, 2012 ~ By Jane Akre    A story before I tell this story.  I was commissioned to write a 2,100 word piece for the Chicago-based magazine “In These Times.”  I had pitched the long-time editor and he said they were very interested. Great I thought. The money wasn’t much but the exposure for an
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Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

Mar 14th, 2012 | By
Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

March 7, 2012 ~ The Union of Concerned Scientists (USC) issued the results of a survey released today of 977 Food and Drug Administration scientists. They were asked about the pressure they feel to approve drugs and medical devices – can they communicate candidly with the public? – can they publish their results? –  is
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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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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.