 |
| Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson |
Johnson & Johnson ($JNJ) is facing more pushback over power morcellator devices used in minimally invasive gynecological procedures, as the FBI investigates how much the company knew about the products' risks before pulling them from the market last year.
The Federal Bureau of Investigation's Newark, NJ, office is heading up the investigation, asking patients and physicians about J&J's knowledge of morcellators' potential hazards, three people interviewed by the agency told The Wall Street Journal. J&J is staying mum on the probe, saying it is not aware of an investigation into power morcellator devices, according to the WSJ story. The FBI's Newark, NJ-based office declined to comment to the newspaper.
Over the past several months, FBI agents interviewed Dr. Robert Lamparter, a former pathologist at Lewisburg, PA-based Evangelical Community Hospital, about his 2006 correspondence with J&J's Ethicon subsidiary about its power morcellator devices. Lamparter reportedly told Dr. David Robinson, Ethicon's medical director at the time, that he was concerned with several issues including the risk of spreading undetected cancer with the devices. But Lamparter never cited a specific case of this happening, the WSJ reports.
J&J acknowledged its correspondence with Lamparter, saying his concerns spurred the company to revise its instructions for the device. And Ethicon morcellators "have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue," J&J spokesman Matthew Johnson told the WSJ.
"We highly value the feedback we receive from physicians, and we are 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," J&J said in emailed statement to FierceMedicalDevices.
Still, the FBI probe does not bode well for the company as it continues to deal with the fallout over related products. In April 2014, J&J suspended sales of its morcellator devices after the FDA warned of risks associated with the tools. In July 2014, J&J pulled its morcellator devices from the global market in light of more public and regulatory pushback.
Meanwhile, the FDA is weighing in on the devices' safety through updated guidance. In November, the agency slapped power morcellators with a "black-box" warning--its strongest caution--recommending against using the tools in the "majority" of women undergoing a hysterectomy for the removal of uterine fibroids. But the FDA has stopped short of banning morcellators altogether, saying the devices' benefits may outweigh the risks in some women.
- read the WSJ story (sub. req.)