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July 16, 2015

Reports of FBI Investigation of Johnson & Johnson for Power Morcellation Device

Following the FDA's warning in April 2014  regarding the 1-in-350 risk of uterine fibroids being cancerous and the potential for the surgical device known as a power morcellator to spread that cancerous tissue during the removal process, key figures involved in the controversy over the safety of morcellation devices have stated that the FBI is investigating the devices’ largest manufacturer: Johnson & Johnson. A formal FBI investigation, however, has not been publicly announced.

It's not clear when the FBI's investigation of Johnson & Johnson began, but a Wall Street Journal article states that over the past several months they have interviewed pathologist Dr. Robert Lamparter regarding his 2006 communications with the manufacturer to "reconsider the risk to the patient," and Dr. Amy Reed regarding her diagnosis of late stage cancer following surgery with a power morcellation device and her and her husband's subsequent efforts to have the device banned. The article adds that the FBI has also spoken with physician assistant Sarah Robinson, who has collected close to 400 names of women and the families of women who believe that the morcellation procedure led to the worsening of their cancer.

Johnson & Johnson, which holds an estimated 72 percent of the power morcellator market, voluntarily withdrew its morcellation tools from the market in July 2014.

In November 2014, the FDA updated its earlier warning to state that it was "warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids" due to the "risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival" if the morcellation procedure is used on women with unsuspected uterine sarcoma.

According to the American College of Obstetricians and Gynecologists (ACOG), approximately 600,000 hysterectomies are performed in the U.S. each year. For women under 40, about 30 percent of hysterectomies are performed laparoscopically while women between the ages of 40 and 49 have this surgery conducted laparoscopically almost 44 percent of the time.

Power morcellator lawsuits have been filed against manufacturers, including Johnson & Johnson, for the alleged harm caused by these devices. Motley Rice medical and power morcellator lawyer Carmen Scott currently represents women allegedly harmed by these devices.