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Ultrasonic Surgical Aspirators Contraindicated for Uterine Fibroid Removal


Washington, DC: The US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids, which has reduced the surgical options for women requiring removal of fibroids.

The fear around the use of ultrasonic aspirators appears to be similar to that of power morcellators, in that the device could inadvertently spread cancerous cells during procedures to remove uterine fibroids.

Ultrasonic aspirators are used surgically to break up both hard and soft tissues with ultrasound energy. The device then sucks out the broken up tissue from the body through a small incision. They're used by a wide variety of surgeons in both open and laparoscopic procedures.

The FDA states in its guidance document that despite the suction of the ultrasonic aspirator, the oscillating tip of the device can disperse the fragmented tissue, which poses a risk of spreading cancerous tissue. Therefore, the agency states that risk does not outweigh the benefits, "particularly since there are alternative treatment options available," the FDA states.

Accordingly, the FDA is recommending the following addition to labels for ultrasonic aspirators indicated for laparoscopic, open, or gynecologic surgery: "Contraindication: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids."

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READER COMMENTS

Posted by
nedra ashley
on
I had this procedure done

Posted by
Floria Taliaferro
on
I received surgery in June of 2012 for fibroids removal.I went in to have a complete hysterectomy .I questioned my docter about the robotic procedure because I wasn't knowledgeable about it so I had concerns.well went the procedure was finished and I was recovering the next day the doctor told me that my heart stop and she couldn't get my ovaries because she was afraid and I have been having bleeding on and off every since I went into her office and complained to her but she swore she couldn't find the problem.I asked for my medical records months later but she wouldn't sighn off on them so I changed doctors.I was told that no one will go behind her to remove my ovaries.

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