WASHINGTON, Oct. 2, 2014 /PRNewswire/ — The US Drug Watchdog is launching an initiative focused on identifying women who had a what is called a laparoscopic power morecellation treatment done, that ending up causing their uterine cancer to actually spread. For more information, potential victims are urged to contact the US Drug Watchdog anytime at 866-714-6466. http://USDrugWatchdog.Com
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The US Drug Watchdog now alerting women who have uterine cancer to avoid having a procedure called a laparoscopic power morcellation without first alerting their physician to their condition. According to the FDA having this procedure done with a woman with uterine cancer could actually cause the cancer to spread. The FDA has indicated this procedure could actually "significantly worsen the patient's likelihood of long term survival."
The US Drug Watchdog says, "If you are a victim of uterine cancer, and you had a procedure called a laparoscopic power morcellation, and your cancer has spread, please call us immediately at 866-714-6466. We just became aware of this situation, and we fear there could be thousands of women at risk." http://USDrugWatchdog.Com
According to a US FDA statement on April 17, 2014, "Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.
"Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health, most women will develop uterine fibroids at some point in their lives. While most uterine fibroids do not cause problems, they can cause symptoms, such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes requiring medical or surgical therapy.
"Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival."
The FDA Warning Included the Following:
Based on currently available information, the FDA's recommendations for health care professionals include:
- Be aware that the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
- Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
- Carefully consider all the available treatment options for women with symptomatic uterine fibroids.
- Discuss the benefits and risks of all treatments with patients.
- After carefully weighing the risks and benefits of the procedure, if a health care professional nonetheless determines that laparoscopic power morcellation is the best therapeutic option for his or her patient, the health care professional should:
- Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
- Be aware that some clinicians and medical institutions now advocate using a specimen "bag" during morcellation in an attempt to contain the uterine tissue and minimize the risk of cancer spread in the abdomen and pelvis.
For attribution please refer to the April 17, 2014 notification from the US Food and Drug Administration http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393689.htm
The US Drug Watchdog says, "If you have had a laparoscopic power morcellation procedure done within the last three years, and you had a pre-existing condition of uterine cancer please call us at 866-714-6466, if the procedure made the cancer worse." http://USDrugWatchdog.Com
Media Contact:
M. Thomas Martin
866-714-6466