Posts Tagged ‘
Class II ’
Mar 29th, 2013 |
By Jane Akre
March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The experts suggested that because of the
[continue reading...]
Posted in FDA |
10 comments
Tags: Adverse Event, Class II, Class III, Dr. Benson, erosion, FDA, Food and Drug Administration, High-Risk Device, Linda Gross v Ethicon, MDND, Mesh medical Device News Desk, non-mesh surgery, not rare, pelvic organ prolapse, POP, premarket review, Stress urinary incontinence, SUI, SUI mesh, SUI mesh injuries, SUI repairs
Jun 20th, 2012 |
By Jane Akre
Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant. It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA. The
[continue reading...]
Posted in FDA |
No Comments »
Tags: 510(k), A.S.R, acetabular component, advisory panel, Ann Morrison, BBC, birmingham Hip Resurfacing, British Medical Journal, chromium, Class II, Class III, cobalt, DePuy, FDA, Howard Sadwin, Johnson & Johnson, Medtronic, metal ions, metal-on-metal hips, MoM, recall, resurfacing system, Smight & Nephew, total hip replacements, transvaginal mesh
Apr 2nd, 2012 |
By Jane Akre
April 1, 2012 ~ The May issue of Consumer Reports (here) features an investigation into synthetic mesh and artificial hips – medical devices that escape rigorous testing to assure safety. Tens of millions of Americans are living with medical devices and whether a defibrillator, artificial hip or surgical mesh, – 90 percent of those devices
[continue reading...]
Posted in Media Reports |
No Comments »
Tags: Class II, Cleveland Clinic, Consumer Reports, Consumers Union, debilitating injuries, Defective device, Hernia Mesh, mesh kits, moderate risk, safe and effexctive, substantial equivalence, surgical mesh
Jan 12th, 2012 |
By Jane Akre
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
[continue reading...]
Posted in Legal News |
2 comments
Tags: American Medical Systems, Bard Avaulta mesh, Boston Scientific, Class II, Class III, Ethicon, FDA, Food and Drug Administration, Incontinence, infection, Johnson & Johnson, Judge Joseph R. Goodwin, Judicial Panel on Multidistrict Litigation, MDL, medical device, mesh complications, mesh erosion, mesh injuries, mesh migration, Multidistrict Litigation, not rare, pelvic organ prolapse, product liability litigation, transvaginal mesh
Sep 13th, 2011 |
By Jane Akre
MedPage Today (here) reports an FDA advisory panel meeting over synthetic mesh used to treat stress urinary incontinence (SUI) said it would like more scientific data on the newer generation of devices but recommended leaving in place the 510(k) approval process. FDA Panel Listens to Industry, Patients, Staff The Obstetrics and Gynecology Devices panel issued
[continue reading...]
Posted in Media Reports |
No Comments »
Tags: Benefit, Class II, Class III, high-risk, Incontinence, MAUDE, mesh, pelvic floor problems, POP, Risk, SUI