premarket approval

/Tag:premarket approval

FDA: *IMPORTANT* How To Weigh in on Reclassifying Pelvic Mesh To High-Risk!

Prolene mesh *NEW*  Readers of Mesh News Desk understand that the Food and Drug Administration has allowed  the polypropylene-based material onto the market to treat pelvic organ prolapse and incontinence with very little scrutiny.  In fact, the 510(k) approval process is an approval to sell, and does not Read more

By | 2014-04-29T13:08:17+00:00 April 29th, 2014|FDA News|35 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

Op-Ed: Dr. Shezad Malik on Doctors and Transvaginal Mesh

Dr. Shezad Malik, MD, JD Op-Ed: Dr Shezad Malik Law Firm http://www.shezadmalik.com/ Dr. Malik is a cardiologist and now an attorney in Dallas who heads his own law firm. He is board certified in internal medicine and was a practicing cardiologist for 10 years. In 2003 he decided Read more

By | 2013-07-02T17:50:59+00:00 July 2nd, 2013|Op-Ed|3 Comments

Suffering in Silence: Nonie Wideman ~ Canadian Child Advocate and Rancher Sidelined By Transvaginal Mesh

Noni Wideman Nonie Wideman might be considered one of those angels on earth who pays it forward by taking into her home kids with all sorts of special and emotional needs – those who have suffered trauma and abuse, autism, ADHD, fetal alcohol syndrome, and handicaps, among other Read more

By | 2018-01-10T15:13:37+00:00 May 21st, 2012|News, Patient Profiles|11 Comments

Suffering in Silence: Howard Sadwin’s Story of Metal-on-Metal Hip Failure

Howard Sadwin is 65 years old and lives in Sarasota, Florida. Life has not been the same since a metal-on-metal hip implant in 2007. In fact, during his 10-month hospital stay, Howard’s doctor leaned over and whispered to him that Howard was dying. But Sadwin survived and today is fighting Read more

By | 2012-03-05T23:18:35+00:00 March 5th, 2012|News, Patient Profiles|7 Comments

Consumers Union's Safe Patient Project Brings Eight Activists to Congress

CU's Safe Patient Project February 6, 2012 ~ Consumers Union is bringing eight patient activists to Washington, D.C. to meet with lawmakers and press for strengthened medical device oversight. The timing is important. The Food and Drug Administration’s budget will be determined by the Medical Device User Fee Read more

By | 2012-02-06T21:34:14+00:00 February 6th, 2012|Featured|0 Comments

Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

  February 1, 2012 ~ Bloomberg reports on a bill  introduced this week that would put the brakes on the approval of a medical device that claims to be similar to another approved device that's been recalled or found to be defective. The bill was introduced by Democratic Read more

By | 2012-02-02T18:24:49+00:00 February 2nd, 2012|Legal News|0 Comments

LATEST FDA REPORT: Classify Surgical Mesh Devices for Pelvic Surgery as High Risk Class III

Prolene Mesh If a U.S. Food and Drug Administration (FDA) staff report is adopted, synthetic surgical mesh manufacturers such as Boston Scientific Corp., Johnson & Johnson, American Medical Systems and six other makers of  mesh used for pelvic organ prolapse (POP) repair may be forced to submit safety Read more

By | 2011-09-01T05:07:59+00:00 September 1st, 2011|FDA News|2 Comments

Gateway FDA: The New 510 (k) Guidance: A Product Liability Perspective, Gateway FDA, August 26, 2011

This August 26, 2011 blog on Gateway FDA is written for the medical device industry and its lawyers. The FDA recently issued new draft guidelines so manufacturers understand how to comply with the controversial 510(k) fast-track approval for marketing of their medical device. The new guidelines replace the 1997 guidelines Read more

By | 2011-08-26T22:52:14+00:00 August 26th, 2011|FDA News, Media Reports|0 Comments