SOMERVILLE, N.J. — Makers of the dangerous cancer-spreading device, the power morcellator, are being investigated by the FBI.
The FBI is looking into whether Ethicon, the division of Johnson & Johnson that manufactured the most popular power morcellators, knew of the dangers around using the device. Dr. Amy Reed and her husband, Dr. Hooman Noorchashm, are the two biggest advocates for a full FDA ban of morcellators. They were recently interviewed by the FBI to discuss their concerns. Dr. Reed underwent a hysterectomy in 2013, and as with most minimally invasive hysterectomy procedures, a power morcellator was used. Shortly thereafter, it was discovered she had an aggressive form of cancer that spread outside of her abdomen. She and her husband reached out to the FBI in late 2013. They were interviewed in October 2014 and again this summer.
The power morcellator is a device that was once popular with the surgical community. It was touted as a minimally invasive means of performing hysterectomies and myomectomies. The device is a series of small blades that are attached to a tube. It is inserted through a small incision in the abdomen where it proceeds to shred the tissue into tiny pieces. These pieces are then sucked out of the body through the tube. It is a simple way to quickly perform what used to be very invasive operations.
The dangers of the morcellator, however, quickly became apparent. Typically women undergo this type of procedure in order to have a hysterectomy (for a variety of reasons) or to remove benign fibrous tissue from their uterus, also known as uterine fibroids. The problem is that frequently hidden (and dormant) in these fibroids is a dangerous form of uterine sarcoma (cancer). It is impossible to tell prior to surgery if a fibroid has such cancerous cells. When the morcellator is used, the tissue is shredded thus flinging the cancerous cells elsewhere in the body where they quickly spread/metastasize. Many women have since had to suffer significant chemotherapy treatment and surgery, and many have succumbed to the cancer.
The FDA found that 1 in 350 women who underwent a hysterectomy or myomectomy for the treatment of fibroids have an unsuspected cancer, including the very aggressive leiomyosarcoma. In response to the study, the FDA issued its strongest black box warning on the device, but did not outright ban it. Very large insurance companies, such as Aetna and UnitedHealth, have stopped covering use of the device. Johnson & Johnson’s division Ethicon recalled its power morcellator and sent out a strong warning to surgeons, but many power morcellators remain in the market and in use. The FBI’s investigation of the device may prove as the next critical step to protecting women from this deadly device.
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