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Federal health officials are considering whether they need to review and set new guidelines for how thoroughly gynecologists should examine women for signs of uterine cancer before a hysterectomy or uterine fibroid removal.
A number of reports indicate that the U.S. Centers for Disease Control and Prevention (CDC) may convene an advisory panel in the near future to look at whether the agency should take action to ensure that gynecologists performing biopsies on women who may undergo uterine fibroid removal are satisfactorily evaluating those patients for hidden malignancies.
The concerns come following a study published in the medical journal Obstetrics & Gynecology last month, which found that the risks of uterine cancer, cervical cancer and ovarian cancer were higher among women undergoing hysterectomy than previously believed.
According to the findings, 1.44% of women undergoing the procedure had unsuspected uterine cancer; 0.60% had cervical cancer, and 0.19% had ovarian cancer.
On May 8, the Center for Science in the Public Interest (CSPI) urged the CDC to move forward with the review, noting that some women undergoing hysterectomy and uterine fibroid removal may have procedures that involve power morcellators, which could spread hidden cancer cells throughout their body cavity.
Morcellators became widely used over the past decade, allowing doctors to cut up and remove the uterus and uterine fibroids through a small incision in the abdomen. The minimally invasive procedures were recommended as a way to limit the risk of surgical complications and reduce recovery time. However, use of the devices has largely been abandoned, since the medical community discovered that morcellators may spread undiagnosed cancer cells contained within the uterus, leading to the rapid upstaging of leiomyosarcoma, endometrial stromal sarcoma and other difficult to treat cancers.
In November 2014, the FDA decided to add a black box warning to power morcellators about the cancer risk, and provided guidance on the limited instances where laparoscopic hysterectomies may be warranted.
“The FDA warnings against morcellation were a necessary step, but the new research and the magnitude of risk it reveals suggest that more must be done: a complete reevaluation of preoperative screening for these patients,” CSPI Director and President Peter Lurie said in a statement. “It is our hope that the CDC leadership will move quickly to establish the necessary guidelines to ensure that all gynecologists utilize adequate risk stratification methods, including robust tissue biopsy methods, to identify women with gynecological cancer preoperatively.”
Johnson & Johnson has faced dozens of morcellation cancer lawsuits brought on behalf of women who suffered problems after a laparoscopic procedure, and wrongful death claims by family members of women who had died of such cancers.
While most of those cases have been resolved through morcellator settlement agreements, a number of other morcellator manufacturers continue to face claims alleging that they failed to warn the medical community about the cancer risks.