viernes, 27 de octubre de 2017

Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Guidance for Industry and Food and Drug Administration Staff

Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Guidance for Industry and Food and Drug Administration Staff

Today, the U.S. Food and Drug Administration (FDA) released the final guidance document, "Product Labeling for Certain Ultrasonic Surgical Aspirator Devices, " which describes the Agency’s current thinking on ultrasonic surgical aspirator device labeling and proposes labeling recommendations. 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 professionals 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 the spread of cancerous tissue 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 agency is not aware of evidence to suggest 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. 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 guidance, the FDA specifically recommends manufacturers of ultrasonic surgical aspirator devices with indications for use in laparoscopic surgery, open surgery, 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 guidance applies to ultrasonic surgical aspirator devices intended for use in, laparoscopic surgery, open surgery or gynecologic surgery. This guidance does not apply to aspirators specifically indicated for other surgical subspecialties, such as gastrointestinal and affiliated organ surgery, urological surgery, and neurosurgery.

Food and Drug Administration
Center for Devices and Radiological Health

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