Professional Statements and Societal Positions Guidelines
Professional Statements and Societal Positions Guidelines
In November 2014, the U.S. Food and Drug Administration (FDA) published a safety communication on laparoscopic power morcellators used for myomectomy and hysterectomy in most women. FDA recommended that manufacturers of these devices include in their product labels a boxed safety warning and wording on contraindications.
In November 2012, the Acessa™ System (Acessa Health, Austin, TX, formerly Halt Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The technology was previously approved in 2010, at which time it was called the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System. The intended use of the Halt 2000GI system was for percutaneous laparoscopic coagulation and ablation of soft tissue. Unlike FDA clearance of the Acessa System, the intended use statement for the Halt 2000GI system does not specifically mention the treatment of uterine fibroids.
