Device Safety

Latest Headlines

Latest Headlines

Registry data shows high risk of blood clot among users of Abbott's bioresorbable stent

Data from a European postmarket registry show that Abbott's Absorb BVS bioresorbable stent performs at a level similar to today's conventional drug-eluting stents on several measures, but not stent thrombosis. The risk of the stent being blocked by a blood clot was 3.4% after one year, a level of performance similar to prior generation drug-eluting stents, according to a recent EuroIntervention study.

Upcoming study to dispute FDA's data on power morcellation risk

Dr. Elizabeth Pritts, director of the Wisconsin Fertility Institute, believes that the FDA is wildly overestimating the prevalence of uterine sarcoma in women undergoing hysterectomies and myomectomies for fibroid removal and worries that banning or restricting use of power morcellators will fail to address the problem, putting women undergoing the procedure at risk of upstaged cancer.

FDA rejects petition to ban transvaginal mesh

The FDA formally rejected a 2011 citizen petition calling for the ban of all nonabsorbable surgical mesh products for transvaginal repair of pelvic organ prolapse in a letter to the Dr. Michael Carome, then deputy director of Public Citizen's Health Research Group, sent out this week. The agency expressed sympathy and agreement with the petitioner's concerns, but did not agree with the proposed remedy.

FDA panel recommends stronger labeling, limiting use of power morcellation--agency may go further

The FDA panel convened to discuss the risk of upstaging uterine sarcoma cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids recommended upgrading the labeling of power morcellators and ensuring that patients are made aware of the risk prior to surgery, among other measures.

Day One: Inside the FDA power morcellator panel

Panelists were concerned about the lack of data on the prevalence of uterine sarcoma among women undergoing hysterectomy or myomectomy surgeries during the first day of the FDA panel on the risks of upstaging uterine cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids.

JAMA study adds to robotic surgery safety concerns

A recent study found that the adoption of the da Vinci Surgical System in 2005 resulted in increased complications in minimally invasive prostatectomies because surgeons were learning on the job--to the detriment of patients.

FDA prepares to weigh risks of uterine fibroid removal tool

After months of warnings and a debate over the safety of laparoscopic power morcellators, the FDA begins its formal decisionmaking process July 10, when the Obstetrics and Gynecology Devices Advisory Committee convenes for two days in what will be one of the agency's most prominent meetings of the year.

Gold nanoparticles on orthopedic implants prevent infection

Gold nanoparticles help prevent the formation of antibiotic resistant biofilm on the surface of orthopedic implants, researchers at the Shanghai Institute of Ceramics discovered.

FDA says using recalled HydroFinity Hydrophilic Guidewires potentially deadly

The FDA slapped its most severe label on Nitinol Devices & Components' recalled HydroFinity Hydrophilic Guidewires, meaning the agency believes "there is a reasonable probability that use of these products will cause serious adverse health consequences or death."

Thousands of hospitals making simple cyber security error, exposing devices

Drug infusion pumps that can be manipulated from afar, defibrillators than can programmed to deliver random shocks, refrigerators whose temperature settings can be reset, these are some of the cybersecurity problems uncovered by Scott Erven, the head of information security for healthcare facility operator Essentia Health.