510(k)

/Tag:510(k)

FDA Funding: Medical Device Makers and Lap Dog Watchdogs

Consumers Union Safe Patient Project Mesh Medical Device News Desk, August 29, 2016 ~ The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates. The Medical Device User Fee Agreement IV Read more

By | 2016-08-29T13:50:55+00:00 August 29th, 2016|FDA News|15 Comments

Report: Deaths Caused by the FDA

Mesh Medical Device News Desk, July 5, 2016 ~ Deaths Caused by the FDA That is the title of a campaign by the Alliance for Natural Health, USA.  Digging into the Food and Drug Administrations (FDA) database, the consumer group, that promotes sustainable natural health, counts 750,659 deaths caused by Read more

By | 2016-07-05T09:49:54+00:00 July 5th, 2016|FDA News|6 Comments

Noni Wideman to Consumers Union Concerning Pelvic Mesh

Mesh News Desk, March 14, 2016 ~ Noni Wideman, a survivor of a polypropylene mesh implant, writes the following letter to Consumers Union.   CU and specifically Lisa McGiffert have been involved in the pelvic mesh issue through Safe Patient Project, proposing that medical devices carry a warranty not unlike Read more

By | 2016-03-18T13:57:09+00:00 March 14th, 2016|Your Turn|5 Comments

Transvaginal Mesh- Emerging or Resolving?

Mesh News Desk, October 14, 2015 ~ As trial lawyers gather in Las Vegas for the twice-yearly Mass Torts Made Perfect, hosted by Levin Papantonio Law, one cannot help but notice the agenda for the last day - areas ahead for future litigation or areas that are waning. As you Read more

By | 2015-10-14T11:17:33+00:00 October 14th, 2015|Media Reports|33 Comments

*New* Power Morcellator Controversy Spurs FDA Proposal – But Does it Go Far Enough?

Power morcellator graphic, WSJ The Wall Street Journal (WSJ) reports on Friday the House passed a bill that would improve the safety monitoring of medical devices. It was inspired by a gynecological device - the power morcellator. The morcellator is a tool that is used to grind up Read more

By | 2015-07-13T15:50:30+00:00 July 13th, 2015|FDA News, Morcellator Injuries|0 Comments

FAVORABLE JURY VERDICTS CONTINUE IN TRANSVAGINAL MESH (TVM) LITIGATION—IS AMS WATCHING?

By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP                 In recent months, Endo Pharmaceuticals made several announcements concerning global settlements in the transvaginal mesh litigation against American Medical Systems (AMS) pending before Judge Goodwin in federal district court in West Virginia (MDL 2325).  Based on the numbers Read more

By | 2014-12-11T15:53:53+00:00 December 11th, 2014|Featured|67 Comments

LEGAL THOUGHTS ON THE AMS TRANSVAGINAL MESH (TVM) SETTLEMENT

By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP                 Recently, Endo Pharmaceuticals announced that it had reached a settlement in principle with four law firms representing plaintiffs in the transvaginal mesh litigation pending before Judge Goodwin in federal district court in West Virginia (MDL 2325).  The Press Read more

By | 2014-05-22T18:18:52+00:00 May 22nd, 2014|Featured|158 Comments

The 510(k) Process – Safety Forgotten

THE 510(k) PROCESS – SAFETY FORGOTTEN By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP The 510(k) process is relied upon by the medical device industry, including pelvic mesh manufacturers, such as Ethicon/Johnson & Johnson, Atrium Medical Corporation, and Davol/Bard, to quickly get devices marketed in the United Read more

By | 2018-06-05T10:53:05+00:00 January 23rd, 2014|Featured|10 Comments

FDA Approves New American Medical System Transvaginal Mesh Sling

AMS new sling RetroArc American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling, according to a press release that appears in the Wall Street Journal. The RetroArc Retropubic Sling System received the Food the Drug Administration’s 510(k) clearance, a standard that does Read more

By | 2013-12-09T23:26:32+00:00 December 9th, 2013|FDA News|2 Comments