Health Controversy: People Gaining Weight for Lap-Band Surgery
News reports this week describe a troubling trend: possible candidates for the Lap-Band weight-loss surgery are putting on more pounds in order to qualify for the procedure. According to a report on MSNBC, Elizabeth Marks, 32, was turned down for surgery once by her insurance company for being less than 100 pounds overweight, but accepted after she gained more. “I just had two weeks of eating all the junk I could,” Mark said. Others, like a woman in Washington state, …
Continue →Hip Implants Targeted for Health-Device Probe
Energy and Commerce Committee Democrats led by Representative Henry Waxman of California wrote a letter asking Republicans to investigate the safety of metal-on-metal hip implants made by companies like Johnson & Johnson. House Democrats also urged an investigation into stents used to clear clogged brain arteries. The letter is part of a push to hold hearings on the devices as the panel focuses on reauthorizing industry user fees that fund U.S. regulators’ review of new medical products. The lawmakers wrote …
Continue →FDA Says More Surgical Mesh Studies Needed
An FDA panel found that pre-approval studies are needed for new surgical-mesh products used to treat pelvic-organ prolapse, as well as research on products already on the market. The safety of transvaginal mesh products are being questioned after more than 1,500 reports of adverse effects between 2008 and 2010. Currently, transvaginal mesh products can be approved without any new research. The are products used to treat pelvic organ prolapse, an often painful condition that affects thousands of women. The mesh …
Continue →DePuy Outsources Patient Claims, Causes Controversy
Johnson & Johnson, whose DePuy Orthopaedics Inc. unit recalled its metal ASR hip replacement last year, is taking an unconventional approach to handling more than 2,000 lawsuits. The company has hired a third party—Broadspire Services Inc., which manages workers compensation for insurance companies and employers—to administer patient claims fro out-of-pocket medical costs associated with the recall. Broadspire’s physicians will ultimately determine whether a patient’s hip should be replaced. Typically, companies and their lawyers handle recalls directly. Some legal and industry …
Continue →Rural ERs Behind in Electronic Prescribing
Emergency departments in rural hospitals are lagging in switching to electronic drug prescriptions, which may mean increased medication errors, a new study finds. Although health providers will eventually face steep penalties if they don’t change their systems, the study uncovered a large gap between urban and rural hospitals’ prescribing methods. The study, reported in the Annals of Emergency Medicine, also found wide variation among the four states — Colorado, Georgia, Massachusetts and Oregon. While Massachusetts was in the lead with …
Continue →Dangerous Pelvic Mesh Creates Worries about FDA Safety
After a number of reports about surgical vaginal mesh-associated complications in women, the FDA issued its second warning about the device in three years. A panel will convene in September to determine whether the medical device needs to undergo more testing. Simultaneously, a group called the Institute of Medicine will issue a report Friday about whether the FDA’s process of approving devices protects patients and promotes innovation in the name of public health. They’re calling into question how the FDA …
Continue →FDA Warns of Transvaginal Mesh Complications
Transvaginal placement of surgical mesh to treat pelvic organ prolapse could result in serious complications, FDA officials warned Wednesday. The agency said it has received almost 3,000 reports of complications from surgical mesh implants used to treat pelvic organ prolapse. Pelvic organ prolapse occurs when one of the pelvic organs slips from its regular location to press against the vagina and cause pain, often after childbirth or a hysterectomy. Surgical mesh is often used to repair those weakened tissues. The …
Continue →J&J’s Metal-on-Metal Hips Subject of 1,000 Lawsuits
Did Johnson & Johnson know about problems with its metal-on-metal joint replacements before it ceased production in 2009? That’s the allegation of approximately 1000 lawsuits directed towards J&J’s DePuy Orthopedic Unit. A Wells Fargo analyst says J&J stands to lose more than $1 billion in liability and other costs, while J&J says it boosted its product-liability reserves by $570 million last year and has also set aside $280 million to cover medical costs of people who received the joints and …
Continue →Lap-Band Death Linked to Anesthesiologist
“Suboptimal care” by an anesthesiologist may have caused a woman to die after a recent weight-loss surgery. The surgery was connected to the 1-800-GET-THIN advertising campaign, according to a report submitted to the Los Angeles County coroner. Tamara Walter died on Dec. 26, only three days after having the Lap-Band surgery performed. A total of four patients in Southern California have now died after being referred by the 1-800-GET-THIN number to Lap-Band surgeries. A Los Angeles County deputy medical examiner …
Continue →Depuy Shoulder Implants Cause Complications
Shoulder implants manufactured by Depuy have recently been linked to complications and shoulder pain. The Depuy Shoulder Mitek Versalock Anchor is a knotless anchor system used to repair rotator injuries, designed to help sutures or stitches hold tendons firmly in place against the bone during surgery. However, the design of the anchor may cause the rotator cuff tendons to separate from the bone. The Versalock Anchor may partially pull out of the bone or completely detach from the bone, causing …
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