May 29, 2015 05:08 PM EDT
Johnson & Johns is under investigation by the FBI for possible prior knowledge about dangers linked to one of their medical devices, the laparoscopic power morcellator, which is supposed to provide a minimally invasive alternative to hysterectomies and removal of fibroid tumors, but in reality, may have been spreading dangerous forms of cancers among its patients.
The tool in questions contains small spinning blades that cut tissue into small pieces so that the tissue can be removed via suction through small incisions on the patient's abdomen. This laparoscopic technique provides a simpler means of performing surgeries, such as hysterectomies, which traditionally required lengthy recovery times due to the opening of the belly.
The problem with the morcellator, however, is that those same little blades that dice up normal tissue and fibroids can spread malignant cells if undetected cancers are present. The investigation centers on how long Johnson & Johnson has known about the potential dangers.
With the investigation ongoing, details from the FBI have been scarce, but it appears complaints from medical personnel about the potential dangers of the morcellator have been ongoing for years. By law, manufacturers, doctors, and hospitals are required to notify the FDA of any potential harmful effects of medical products. Physicians involved in the investigation claim they notified Johnson & Johnson as far back as 2006 about the dangers of using the morcellator on women at high risk for cancer.
The FDA released communications concerning the device in April of 2014, laying out potential dangers.
At the time of the report, the FDA stated that approximately 1 in 350 women undergoing hysterectomy or myomectomy (fibroid removal) for the treatment of fibroids is found to have an unsuspected uterine sarcoma. They warn that there is no reliable method for predicting or testing whether a woman with fibroids may have uterine sarcoma.
They gave a stark warning that using a power morcellator in women with unsuspected uterine sarcoma risks spreading the cancerous tissue within the abdomen and pelvis, which significantly worsens a patient's long-term survival.
They also provided guidelines for contraindications, such as women who are peri- or post-menopausal or candidates for en bloc tissue removal, which make up the majority of patients undergoing hysterectomy or myomectomy.
Johnson & Johnson removed morcellators from the market in July of 2014. As the investigation plays out, their culpability concerning prior knowledge about the dangers of their product should come to light.
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