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Monday, April 21, 2014

Recent Alert Concerning Uterine Fibroids: FDA Warns But Does Not Take Morcellators Off The Market

Many techniques have furthered the technology of having uterine fibroids surgically treated. Vaginal hysterectomies are able to remove large fibroids, and a technique of manual morcellation or manual removal in pieces enhances the ability of the gyno surgeon to get quite a large fibroid removed without any abdominal incisions. Abdominal hysterectomies were then performed for even larger fibroids, and by those surgeons who felt that they couldn't safely perform a vaginal procedure. As laparoscopic hysterectomies became more popular, including the technique of preserving the cervix, called supracervical hysterectomies, gynos required a better way to remove the uterus. Power morcellators were then developed that could essentially remove the tissue in strips. When the tissue is removed in smaller pieces, or if any are inadvertently remain behind in the abdomen, this tissue can in fact cause a cancer to seed if it is already there. If a woman had (has) a prescurgical diagnosis of uterine cancer the morcellator has never been considered an ideal tool as it is known that the less cutting into cancerous tissue the less the spread of any existing cancer will occur. However, the FDA, although it has already approved power morcellators, has had now had cases where there was inadvertant spread of the cancer. No testing, whether it is d and c, endometrial biopsy, hysteroscopy, pelvic ultrasound, or pelvic examination anc 100% reliably detect all cases of uterine cancer in the preoperative period. Although the FDA is stating morcellators may allow for a safer procedure with a quicker recovery, it is warning physicians to discuss the risks and consider alternative surgeries for women having uterine fibroid surgery. The FDA is "discouraging" the use of the devices through this general warning, but has not outright banned the technology. You can read their actual statement on their website. We offer multiple types of hysterectomies through Women's Health Practice and would welcome patients for consultation or second opinion. We also currently are enrolling two uterine fibroid research studies. Call the Clinical Trial Research Coordinator for further information to see if you might qualify for a study. 217-356-3736.

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Vaginal Contraceptive Ring

If you are a female between the ages of 18 and 35 you may be eligible for a contraceptive ring investigational contraceptive medication study. Qualified participants will receive study-related medical evaluations and care at no cost. If interested, please call 217-356-3736.

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