Medical device complaint reportedly draws FBI attention

After a surgical device spread an aggressive but undetected uterine cancer inside anesthesiologist Amy Reed in late 2013, she and her husband launched a campaign to ban electric morcellators.

Now, the Federal Bureau of Investigation has gotten involved, according to Reed's husband, Philadelphia heart surgeon Hooman Noorchashm, and Sarah Robinson, a California woman whose cancer was also worsened by the device. Both said Wednesday that they have been interviewed by FBI agents, and believe the FBI is looking into whether manufacturers failed to report deaths and serious injuries to the Food and Drug Administration, as required by federal law.

"I had been trying to get the FBI's attention for a very long time," said Noorchashm, a heart surgeon at Thomas Jefferson University Hospital. "The FBI's questions surrounded how much the company knew and, despite knowing, how it continued marketing" the device.

Celeste Danzi, spokeswoman for the FBI in Newark, N.J., said the agency does not confirm or deny the existence of an investigation, which becomes public only if criminal charges are filed.

Johnson & Johnson, the New Brunswick, N.J., maker of the leading morcellator, has not been contacted by the FBI regarding its product, said Matthew Johnson, spokesman for the company's Ethicon division.

He said the device's usage instructions "have always included cautions . . . about the potential spread of malignant or suspected malignant tissue." He noted that J&J voluntarily withdrew the morcellator from the market last July, after the FDA issued new safety warnings.

In April 2014, the FDA warned that women undergoing surgery to remove uterine fibroids - benign growths that can cause bleeding and pain - have a 1 in 350 chance of a hidden cancer, leiomyosarcoma, that preoperative tests can't reliably detect. Before Reed's campaign, the complication was believed to be ultrarare, perhaps 1 in 10,000 women.

Reed had a hysterectomy with morcellation in October 2013 in Boston, where the couple then lived and practiced medicine. Tens of thousands of other women have been treated with the electric device since the first one was marketed in 1993.

Gynecological medical groups say morcellators still have benefits in certain cases, because the electric blade enables tissue to be dissected and removed through small abdominal incisions, reducing recovery time and surgical complications. Nonetheless, leading hospitals and large health plans have restricted or abandoned use of the device over the last year.

Noorchashm said he and his wife have been interviewed by the FBI several times since December.

Robinson, a physician assistant now on disability in Los Altos because of her cancer, said she was interviewed by the FBI about two months ago. She provided the agency a list she has compiled of nearly 400 women who believe their cancers were worsened by power morcellation.

"I think the issue here is that, not only was there a problem with the morcellator that harmed many women, but the FDA has a requirement that manufacturers must report such cases," she said Wednesday. "None were reported until Hooman and I" helped women submit their information to the FDA.

The push for an FDA ban also led Robert Lamparter, a retired pathologist at Evangelical Community Hospital in Lewisburg, Pa., to go public with 2006 correspondence in which he warned Johnson & Johnson's Ethicon subsidiary of the danger of morcellating an undetected cancer - a danger that became apparent to him in his own small hospital.

Lamparter could not be reached for comment Wednesday. But he, too, was interviewed by the FBI, according to Noorchashm. A year ago, Lamparter allowed Noorchashm to share the pathologist's e-mails and letters with the journalists, lawmakers, regulators, and others on Noorchashm's vast e-mail list.

"This morning I had a meeting with my former colleague, Dr. Lawrence Ginsburg, medical director at Evangelical Community Hospital, and presented my dilemma - openly report the information and hopefully save some lives, or stay silent and protect my hospital and friends," Lamparter wrote last May in an e-mail Noorchashm shared. "He was supportive of my decision for disclosure, much to my relief!"

Johnson, the Ethicon spokesman, said Lamparter "contacted the company in 2006 seeking advice on ways to collect and evaluate endometrial specimens following morcellation. His questions prompted Ethicon to revise the precautions contained in the device's instructions for use.

After her leiomyosarcoma diagnosis in October 2013, Reed, now 42, underwent massive surgery and chemotherapy. Still, the cancer recurred early this year, requiring surgery to remove part of her spinal column, followed by radiation. She is now at home in Bucks County with the couple's six children, but plans to return to her job at the Hospital of the University of Pennsylvania next month.

She and Noorchashm have expanded their campaign to push for an overhaul of part of the medical device regulation system, which has been faulted by experts - including the influential Institute of Medicine - for allowing many devices to come to market without being tested for safety or effectiveness.

"The Congress has to change the legislation," Noorchashm said.

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