05.29.15
The Wall Street Journal is reporting that the Federal Bureau of Investigation (FBI) reportedly is investigating the use of laparoscopic power morcellator—more specifically, whether officials at Johnson & Johnson (JNJ), the largest manufacturer of this type of device, knew about problems before stopping sales of the product. The devices were made by JNJ’s Ethicon subsidiary.
Despite the Journals report, which names patients who have been contacted by the FBI, JNJ spokespeople have told multiple news outlets that the company has not been contacted by the FBI regarding its Ethicon morcellation devices.
Morecellators are used during minimally invasive hysterectomy procedures to remove uterine fibroids. The devices grind up tissue so that it can be removed through a small incision. When the device, however, was used on women with undiscovered uterine sarcoma cancer, the instrument instead spread cancerous tissue throughout the abdomen and pelvis.
The U.S. Food and Drug Administration (FDA) issued a warning about the risk in April last year, with agency official saying use of the device could “significantly worsen … the patient's likelihood of long-term survival.” By April, the agency required a new and stronger warning on the product label. According to figures cited by the FDA’s Center for Devices and Radiological Health, about 60,000 such procedures were performed every year.
Ethicon advised doctors to stop using the devices and withdrew them from the market, though similar devices made by other companies remain on the market.
Despite the Journals report, which names patients who have been contacted by the FBI, JNJ spokespeople have told multiple news outlets that the company has not been contacted by the FBI regarding its Ethicon morcellation devices.
Morecellators are used during minimally invasive hysterectomy procedures to remove uterine fibroids. The devices grind up tissue so that it can be removed through a small incision. When the device, however, was used on women with undiscovered uterine sarcoma cancer, the instrument instead spread cancerous tissue throughout the abdomen and pelvis.
The U.S. Food and Drug Administration (FDA) issued a warning about the risk in April last year, with agency official saying use of the device could “significantly worsen … the patient's likelihood of long-term survival.” By April, the agency required a new and stronger warning on the product label. According to figures cited by the FDA’s Center for Devices and Radiological Health, about 60,000 such procedures were performed every year.
Ethicon advised doctors to stop using the devices and withdrew them from the market, though similar devices made by other companies remain on the market.