Archive for September, 2009

FDA reconsidering approval of ReGen knee device

RegenThe FDA is reconsidering the approval of ReGen Biologics Inc’s knee device after an investigation showed that unprecedented industry and Congressional involvement influenced the agency’s decision. Joshua Sharfstein, the agency’s principal deputy commissioner, said, however, that patients who have had Menaflex implanted in their knee need not panic and noted that the device is still on the market. ReGen Chief Executive Gerald Bisbee said in a statement that the report didn’t evaluate the scientific evidence about the device. The company said the product is safe and helps knee-surgery patients recover more quickly.

Nucleus 5 System implant for hearing impaired approved

CochlearThe FDA has approved Cochlear’s Nucleus 5 System for adults and children with severe-to-profound hearing loss. The Nucleus 5 System is the only one of its kind on the market today that offers the smallest, most water resistant sound processor, the thinnest titanium cochlear implant, two-way remote assistant, SmartSound((TM)) 2 technology and AutoPhone (TM) capability.

Study: LUNA not effective for alleviating chronic pelvic pain

BrighamAccording to a study published in the September 2 issue of JAMA laparoscopic uterosacral nerve ablation (LUNA) does not result in the improvements in chronic pelvic pain, painful menstruation, painful sexual intercourse or quality of life, when compared with laparoscopic surgery that does not interrupt pelvic nerve connections. The study was conducted by a team from Birmingham Women’s Hospital, University of Birmingham.

Impact of obesity surgery extends to next generation

Clinical EndochronologyA new study shows that children born to women who have achieved drastic weight loss through stomach surgery are healthier than children born to severely obese moms. The findings suggest that obesity creates an unhealthy environment for a fetus that has ramifications later on, scientists report in the November Journal of Clinical Endocrinology & Metabolism. Dana Dabelea, a physician and epidemiologist at the University of Colorado–Denver and the Colorado School of Public Health in Aurora said “This is the first proof that exposure to obesity in utero is associated with long-term effects.”