The Food and Drug Administration (FDA) recently issued a warning that power morcellators used in laparoscopic hysterectomies and surgeries to remove uterine fibroids can increase a woman’s risk of developing uterine cancer.
Following the FDA’s warning, several morcellator manufacturers have recalled or stopped selling their devices that are designed to assist in breaking down a uterus or large fibroid tumor that can then be removed laparoscopically. There is growing evidence that the use of the morcellator can spread undetected cancerous tissue throughout a woman’s pelvic region.
According to the FDA, one out of every 350 women undergoing a hysterectomy or fibroid removal surgery will have undetected cancer. As the morcellator mechanically breaks down the uterus and fibroid to prepare its extraction from the body, these cancerous cells can spread, leaving women at an increased risk for uterine sarcoma and other gynecologic cancers.
In a recent report issued by John Hopkins University, two cases of uterine cancer were reported among 424 patients who underwent a hysterectomy or myomectomy surgery using the morcellator. In an effort to prevent further risk of injury to its patients, John Hopkins University announced that it would discontinue the use of morcellators in surgeries involving women over 50 who have risk factors for uterine cancer that include genetic factors, BRCA mutations, history of pelvic radiation, or have used the drug tomoxifen.
The FDA is advising women who are facing gynecological surgery to discuss the risks involved with their doctors before undergoing any procedures. If morcellators are suggested, patients need to question its benefits and risks and investigate all options. Prior to surgery, the FDA advises women to undergo extensive preoperative testing that includes cervical cytology, endometrial tissue biopsy, and ultrasound or MRI imaging to detect any cancer that may be present.
For patients that have already undergone a surgical procedure that involved morcellation, the FDA advises them to continue regular checkups and careful screening for early detection of any underlying cancers that could develop. Even those who underwent surgery using the morcellator and tested negative for cancerous tissue should still follow this protocol.
To date, only a small number of lawsuits have been filed claiming that the morcellator used during a hysterectomy or myomectomy caused the spread of uterine cancer in patients. Legal authorities anticipate medical malpractice, product liability, and wrongful death lawsuits being filed in the near future as more women become aware of the dangers associated with the use of morcellators, and the connection between the device and their cancer diagnosis.
If you or a loved one have been injured and need to speak with an attorney, Call Injury Attorney Martin E. Goff Today at (567) 298-4661
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