Archive for January 2012

FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

Jan 30th, 2012 | By
FDA Whistleblowers Sue Agency, Claim Retaliation Over Unsafe Medical Device Revelations

January 30, 2012 ~ What’s going on inside the FDA? Six of the “FDA Nine” whistleblowers are suing the agency for illegally spying on their private email claiming they were retaliated against after they warned lawmakers that unsafe medical devices were being approved for market.  You may recall as President Obama was taking office on
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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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New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

Jan 19th, 2012 | By
New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project on Government Oversight writes about the 510(k) process that allows untested medical devices onto the market without premarket approval. Share this:



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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Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation

Jan 12th, 2012 | By
Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation

JANUARY 12, 2012 ~ A growing number of women from around the country who are plaintiffs in transvaginal mesh litigation have a court date of Wednesday, January 26 in Miami. The Judicial Panel on Multidistrict Litigation (MDL)  is set to hear requests by plaintiff attorneys to have thousands of defective mesh lawsuits consolidated in the
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Bad Apples and the Defective Silicone Breast Implants Distributed Worldwide

Jan 10th, 2012 | By
Bad Apples and the Defective Silicone Breast Implants Distributed Worldwide

JANUARY 10, 2012 ~ The front-page headlines in Europe concern substandard and defective breast implants made by the French company Poly Implants Protheses (PIP) that ruptured and deflated leaking machine-grade silicone in the women who had the implants to enhance their appearance or to mask the effects of disfiguring breast surgery. Share this:



Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

Jan 9th, 2012 | By
Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

JANUARY 9, 2012 ~ The following is a list of the companies who received the letters from the Food and Drug Administration (FDA) January 3, 2012, requesting three years of followup studies on the complications associated with synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence. This is unprecedented in that the
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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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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.