Posts Tagged ‘ medical device ’

Wall Street Journal: Transvaginal Mesh and $800,000 Conflicts of Interest

Mar 14th, 2014 | By
Wall Street Journal: Transvaginal Mesh and $800,000 Conflicts of Interest

Some of the names in this story may sound familiar, primary among them  Dr. Vincente Lucente. He was one of the doctors mentioned during the Linda Gross transvaginal mesh trial naming manufacturer Ethicon (Johnson & Johnson). Lucente was one of the young doctors brought under the wing of Ethicon to be a preceptor, or trainer
[continue reading...]



When the Sales Rep is in the Operating Room

Aug 27th, 2013 | By
When the Sales Rep is in the Operating Room

One of our very smart readers,  Jade, brought this article to my attention.  Imaging your doctor learning about a new medical device in a weekend cadaver clinic. Then image your doctor being schooled on use of the device, how to implant it for example, with the sales rep in the operating room along with you,
[continue reading...]



Pap Smears: A Technican Speaks Out About Problems and Profits

Jun 20th, 2013 | By
Pap Smears: A Technican Speaks Out About Problems and Profits

June 20, 2013 ~Mark K. is a laboratory technician whose job it is to read PAP smears, the annual test recommended to screen for cervical cancer for most women. In a rare insider opinion, he shares with readers of MDND what he feels is not working. It is a rare look at what many rank
[continue reading...]



PBS “Need to Know” Friday, March 22 on FDA and Medical, Surgical Devices

Mar 22nd, 2013 | By
PBS “Need to Know”  Friday, March 22 on FDA and Medical, Surgical Devices

March 22, 2013 ~ Friday night, March 22, Public Broadcasting (PBS) looks into the U.S. Food and Drug Administration (FDA) oversight of medical devices and how so many enter the market with little review and oversight. The 510(k) process allows devices on the market after the manufacturer requests clearance from the FDA and names a
[continue reading...]



Fishing for Clients

Dec 15th, 2012 | By

December 15, 2012~ It’s unfortunate…. women and men injured by mesh and medical devices receive will sorts of solicitations online.  Some claim to be the Watchdog of America, on your side, and  fighting for justice… Beware, many are legal referral services.   Basically they take your email after you pour your heart out to them and
[continue reading...]



Most High-Risk Heart Devices Approved With No Tests

Nov 25th, 2012 | By
Most High-Risk Heart Devices Approved With No Tests

November 24, 2012 ~  Most readers of Mesh Medical Device News Desk are familiar with the ease with which surgical mesh and other medical devices make it to the market. An exchange of paperwork and a claim of ‘substantial equivalence’ to another device already being sold, and a manufacturer can launch his product- even a
[continue reading...]



FDA Follows Industry Lead to Shorten Time to Market

Oct 31st, 2012 | By
FDA Follows Industry Lead to Shorten Time to Market

October 30, 2012 ~    The FDA has issued the new rules for medical device makers to speed up the time it takes for medical devices to make it to market. Earlier this year industry agreed to pay $595 million over 5 years to the FDA as part of its operating budget. In exchange, the
[continue reading...]



FDA: How to Follow Medical Devices?

Sep 4th, 2012 | By
FDA: How to Follow Medical Devices?

Public Invited to FDA meeting on Postmarket Surveillance September 4, 2012~ Every modern day vehicle comes complete with a VIN number, an identifier number that stays with the car during its lifetime. If there is an auto recall the owner is notified and an auto dealership can easily identify a vehicle that might fall under
[continue reading...]



FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Jun 14th, 2012 | By
FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in
[continue reading...]



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.
[continue reading...]



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.