Lawsuits over a Johnson & Johnson laparoscopic power morcellator has the FBI investigating the surgical device found to be responsibility for spreading cancer in women. It's also suspected that Johnson & Johnson knew about the device's hazards prior to yanking it off the market in 2014, according to The Wall Street Journal.
The Federal Bureau of Investigation's Newark office in New Jersey is overseeing the investigation.
All of this began after the FDA warned last November that morcellators shouldn't be used on a majority of women. The Johnson & Johnson laparoscopic power morcellator was used in thousands of minimally invasive procedures each year. The device eliminated benign uterine growths -- known as "fibroids" -- so that tissue could be removed through very small incisions. This practice was widely used in hysterectomies.
It was reported that that 1 in 350 women undergoing fibroid surgery had a chance of harboring dangerous uterine sarcoma that "can't be reliably detected before the operation." Instead, morcellators can spread the malignancy and make the outcome worse, the FDA claimed. The FDA called for its strongest warning on the device, known as a "black-box." Later on, Johnson & Johnson took the tools off the market, but other mocellator manufacturers kept theirs on sale.
Robert Lamparter is a former pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania and spoke with the FBI interviewed about his 2006 correspondence with the Johnson & Johnson subsidiary that sold the power morcellators. He wrote about his concern regarding several issues, which didn't exclude the potential for an "undetected cancer to be inadvertently spread by the surgical instrument."
Lamparter's small hospital performed 292 hysterectomies the previous year and gynecologists discovered an unexpected malignancy at least once a year after that. This led to suspicion of the device even further.
J&J spokesman, Matthew Johnson, said the company is "continually assessing the totality of the available data and information—including peer-reviewed studies and scientific literature, as well as physician feedback—related to our products."
Johnson also confirmed the 2006 correspondence with Dr. Lamparter prompted the company to revise the instructions for the laparoscopic power morcellator.
About Lawsuits includes the facts in its report that numerous women of uterine fibroid morcellation lawsuits are now "being pursued on behalf of individuals diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other cancers spread following a hysterectomy or myomectomy performed laparoscopically or through robotic surgery.
"Plaintiffs allege that as they were originally designed and sold, power morcellators are unreasonably dangerous."
[Photo Credit: Daniel Acker/Bloomberg]