sábado, 12 de noviembre de 2016

FDA Issues Draft Guidance on Product Labeling for Certain Ultrasonic Surgical Aspirators

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Today, the U.S. Food and Drug Administration released the draft guidance document, "Product Labeling for Certain Ultrasonic Surgical Aspirator Devices." Ultrasonic surgical aspirator devices (aspirators) are surgical tools commonly used for a wide range of procedures to break down, liquefy, and remove hard and soft tissue.    
Health care providers may use aspirators in some patients with advanced cancer to remove a portion of a malignant tumor that cannot be completely removed in an effort to enhance the effectiveness of radiation or chemotherapy. When used in patients with advanced cancer, the risk of adverse effects from tissue dissemination from these devices may be small compared to the device’s potential benefits, such as more extensive tumor debulking (surgical removal of as much of a malignant tumor as possible), minimal to no collateral thermal damage (heat damage to surrounding tissue and organs caused by the procedure), and avoiding the resection or removal of organs.
Although the FDA is not aware of evidence to suggest that health care providers are routinely using aspirators for fibroid removal, the labeling of certain ultrasonic surgical aspirator devices includes an indication for use in patients with symptomatic uterine fibroids. However, the FDA believes the benefits of using aspirators do not outweigh the risks for this indication. Since there are currently no reliable preoperative screening procedures to detect uterine sarcoma in women with presumed benign fibroids, there is a chance that women undergoing surgery to remove fibroids using an aspirator may have an unknown cancer. Use of an aspirator on uterine fibroids in a woman with an unknown uterine sarcoma could cause the cancer to spread. This risk outweighs any potential benefits in this patient population, particularly since there are alternative treatment options available. 
With this draft guidance, the FDA provides labeling recommendations to promote the safe and effective use of aspirators. The FDA specifically recommends that manufacturers of ultrasonic surgical aspirator devices with a general indication for use in general surgery, laparoscopy, or gynecologic surgery do the following:
  • include a contraindication in their product labeling that states that the device should not be used to remove uterine fibroids; and
  • review and update other portions of their device’s labeling to be consistent with this contraindication.
It is important to note that this draft guidance applies to ultrasonic surgical aspirator devices intended for use in general surgery, laparoscopy, and gynecologic surgery. This draft guidance does not apply to aspirators specifically indicated for other surgical subspecialties, such as gastrointestinal and affiliated organ surgery, urological surgery, and neurosurgery.
We welcome your comments and suggestions regarding this draft guidance. The comment period will be open for 60 days in the Federal Register under Docket Number: FDA-2016-D-3275.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health