Morcellators is a powerful surgical device used for removing large masses of tissues during laparoscopic surgery. In hysterectomy, these devices are used to mince up the large masses of tissues into smaller pieces so that it can be extracted from the abdomen. Now days, morcellators are being pulled from the market and their use in some surgical procedures is now being discouraged due to the potential cancer risks associated with them.
Since April 2014, the Food and Drug Administration has been discouraging the use of morcellators for performing uterine procedures. The FDA warns that these devices may help spread cancer during fibroid removal. Studies conducted by the agency revealed that one in 352 women who undergo surgery for uterine fibroids suffer from undiagnosed uterine sarcoma. In addition, 1 in 498 women are found to have undiagnosed leiomyosarcoma.
After undergoing morcellator procedure, the lifespan of the patient is approximately 2 to 3 years. Only 15 percent of women diagnosed with Stage 4 leiomyosarcoma are likely to survive after 5 years. Women are 4x more likely to die from uternine sarcoma if they have undergone the morcellation procedure.
According to the website of Williams Kherkher, morcellators are no longer safe and effective medical devices for performing various procedures like hysterectomy or myomectomy. The FDA issued a second warning regarding these devices in November 2014. Pharmaceutical company Johnson & Johnson then recalled three of its power morcellators after results of a study revealed a significant correlation between the use of morcellators and the development of cancer.
As part of its safety warning, the FDA recommended the inclusion of a boxed warning informing doctors about the potetial cancer risk of using morcellators and then sharing these information with patients prior to their surgery.
As of May 2015, the FBI has been conducting investigations as to whether manufacturers of the morcellators are violating the law by not reporting the risks associated with the procedure.Read More