The FBI is investigating a surgical device that was found to
spread cancer in women, including looking into what the largest
manufacturer of it, Johnson & Johnson, knew about the tool's
hazards before pulling it off the market last year, according to
three people who have been interviewed.
It is unclear what stage the inquiry is in. The Federal Bureau
of Investigation's Newark, N.J., office, which is overseeing the
investigation according to the three people interviewed, declined
to comment. A J&J spokesman said the New Jersey-based medical
company isn't aware of an investigation into the device, called a
laparoscopic power morcellator.
Over the past several months, FBI agents have interviewed a
retired pathologist who alerted J&J about potential problems
with morcellators in 2006, a doctor who went public after her own
cancer was worsened by the tool in 2013, and a California woman who
has collected names of close to 400 patients and families of
patients who may have been harmed by the tool, these people
said.
The probe comes after the U.S. Food and Drug Administration
warned in November that morcellators shouldn't be used on the vast
majority of women.
Many hospitals and the nation's largest health plans either have
curtailed use of morcellators or are considering limits.
Previously used in tens of thousands of minimally invasive
procedures a year, power morcellators cut up benign uterine growths
known as fibroids so the tissue can be removed through tiny
incisions. The device is mostly used in hysterectomies.
The FDA warned in April 2014 that women undergoing fibroid
surgery have a 1 in 350 chance of harboring dangerous uterine
sarcoma that can't be reliably detected before the operation.
Morcellators can spread the malignancy and worsen the outcome, the
FDA said. In November, the FDA called for a "black-box"
warning—its strongest caution—on the tool.
J&J withdrew the tools from the market last year.
Robert Lamparter, a former pathologist at Evangelical Community
Hospital in Lewisburg, Pa., said the FBI interviewed him on May 12
about his 2006 correspondence with the J&J subsidiary that sold
morcellators.
Dr. Lamparter contacted the company's Ethicon division after he
began noticing more morcellated specimens in his lab, according to
emails and letters reviewed by The Wall Street Journal. He wrote
that he was concerned about several issues, including the potential
for an undetected cancer to be inadvertently spread by the surgical
instrument.
Dr. Lamparter wrote in a February 2006 email to David Robinson,
then an Ethicon medical director, that at his small hospital,
gynecologists were surprised by an unexpected malignancy at least
once a year, for a "1/150 to 1/300 chance that a uterus will have
an unexpected malignancy."
"If a morcellation is done, the patient's survival is
jeopardized," Dr. Lamparter wrote. He didn't identify a specific
case of this happening.
J&J spokesman Matthew Johnson confirmed the 2006
correspondence with Dr. Lamparter on Tuesday and said the doctor's
concerns led the company to revise the instructions for use for the
device.
The new language included a line saying that if cancer is
present, use of the morcellator "may lead to dissemination of
malignant tissue," Dr. Robinson wrote Dr. Lamparter in April
2006.
The company's instructions had already recommended that doctors
who suspected or know of malignant tissue should use a "tissue
extraction bag"—a bag used to pull tissue from the
body—with the device.
Dr. Robinson, who is retired from Ethicon, couldn't be reached
for comment.
Ethicon morcellators "have always included cautions in their
instructions for use about the potential spread of malignant (or
suspected malignant) tissue," Mr. Johnson said in a statement to
the Journal.
Mr. 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."
Other people said their conversations with the FBI didn't center
on J&J or other manufacturers.
Amy Reed, a 42-year-old Pennsylvania anesthesiologist who has
been vocal about her worsened cancer after she underwent a
hysterectomy with a morcellator at a Boston hospital in 2013, said
the FBI has interviewed her several times over the past few months
about her case.
The hospital where she had the procedure has acknowledged it
worsened Dr. Reed's cancer and that the device had spread
malignancy in another patient in 2012.
Sarah Robinson, a former physician assistant in Los Altos,
Calif., said she was contacted by the FBI about two months ago. Ms.
Robinson, who testified at an FDA hearing on the morcellator, has
collected a list of women and families of women who believe their
cancer was worsened by the device. Ms. Robinson said she sent an
FBI agent a list of 386 names, which includes herself, on April
3.
Write to Jennifer Levitz at jennifer.levitz@wsj.com
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