March 31st, 2008 amy
To add to the great drug coated stents safety and effectiveness debate, data showing strong clinical efficacy for Medtronic’s Endeavor drug coated stent were presented yesterday at the American College of Cardiology meeting. Entitled “One-Year Clinical and Angiographic Results in Diabetics from ENDEAVOR IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System Versus […]
March 31st, 2008 joshua
The Food and Drug Administration (FDA) is pursuing a $2.2 million penalty against a California cochlear implant hearing aid maker because its device poses a public health risk.
The FDA says Advanced Bionics LLC violated federal law as its manufacturing standards don’t meet the federal standard, and the company failed to notify the FDA when it […]
March 28th, 2008 amy
The Canwest News Service published an interesting article Wednesday reporting that one in seven Canadians who have knee or hip replacement surgeries are ending up back in the hospital within a year.
The article reports, “Of the 51,029 people who underwent a first-time knee or elective hip replacement in 2005-2006, more than 7,700 returned to […]
March 27th, 2008 amy
Intra-articular pain pumps used in shoulder surgeries can cause a lifetime’s worth of pain, even permanent disability. The pain pump catheter, placed into the shoulder joint during the surgery, can cause deterioration of the cartilage — a condition called Postarthroscopic Glenohumeral Chondrolysis (PAGCL). In 2006, one study found that 12 patients out of 152 developed […]
March 26th, 2008 amy
The long-awaited drug coated stents proposed guidelines have finally been posted by the FDA, following more than two years worth of concern that drug-eluting stents may cause deadly blood-clotting more often than bare metal stents.
Per the FDA,approximately one million U.S. patients undergo procedures to treat hardening or blockages of the heart arteries, a condition that […]
March 26th, 2008 joshua
The Waxman cometh to the rescue of victims of faulty medical devices.
After a recent Supreme Court ruling, it appeared the ability to sue a medical device maker if its FDA-approved device failed them. The high court ruled federal approval trumps any state law and provides immunity for device makers of inferior grade.
But the Medical Device […]
March 25th, 2008 amy
The defective Kugel Mesh Hernia Patches are still injuring people, and new claims are still being filed, particularly since the beginning of 2008. In January, the Rhode Island Federal Judge hearing Kugel patch cases expanded the proceedings to include all lawsuits claiming injuries caused by Davol’s defective hernia patches — even those not included in […]
March 25th, 2008 joshua
Stryker Corp’s CEO took a huge pay cut in 2007, somewhat mirroring his company’s performance, but there certainly aren’t any tough times at the MacMillan home.
Despite the company’s name repetitively coming up in recall, contamination and FDA warning letter news, Stryker CEO Stephen P. MacMillan still earned a compensation package valued at $2.3 million in […]
March 24th, 2008 amy
Michael Mastromarino finally pleaded guilty last Tuesday for a laundry list of charges ranging from body stealing to forgery in the Brooklyn body parts and tissue scandal which leaves thousands of people transplanted wondering whether they’ll be sickened by the tissue of diseased corpses. The Biomedical Tissue Body Parts Scandal leader faces 18-54 years in […]
March 24th, 2008 joshua
The focus of the federal inquiry looking into kickbacks physicians received to use certain hip and knee implant parts is now squaring on doctors, according to a New York Times report.
The five major makers of these devices have settled with the government and agreed to pay $310 million in civil charges after admitting to paying […]
