San Diego, CA – May 28, 2015
The Federal Bureau of Investigation has begun their investigation into whether medical device makers, doctors, and hospitals broke the law by failing to report issues linked to the power morcellator tool that is used during gynecologic surgery.
Over the past months, FBI agents have interviewed a retired pathologist who previously alerted Johnson & Johnson about potential issues 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 successfully collected the names of nearly 400 patients and families of patients who have been potentially harmed by the power morcellator.
Dr. Reed, a 42-year-old anesthesiologist, had a hysterectomy because of fibroid tumors in her uterus in October 2013 at a hospital in Boston. Although fibroids are benign, they can hide cancer. After Dr. Reed’s surgery, she had a biopsy which found a hidden sarcoma, an aggressive type of cancer. The tumor spread, the result being Stage 4 cancer. Reed went through bouts of chemotherapy and radical surgery, but the cancer resurfaced in March of this year, requiring even more surgery.
Dr. Reed and her husband have begun a nationwide campaign to ban morcellation, but gynecology groups have resisted saying that morcellation makes surgery less invasive and safer for women.
The investigation comes after the FDA warned in November that morcellators shouldn’t be used on the vast majority of women. Hospitals and health plans are either ceasing use of the tool of considering limited use.
The power morcellator is a tool with rapidly spinning blades that cut tissue into pieces which are removed from the body through tiny slits made during surgery. Morcellators are most frequently used in surgery to remove the uterus, but in women with undetected cancers they have tragically sprayed malignant cells around the abdomen like planting seeds for the cancer to worsen.
Dr. Lamparter recently spoke to the FBI regarding the power morcellator, and they primarily spoke about his 2006 correspondence with Ethicon, the section of Johnson & Johnson that sold power morcellators. In 2006, Lamparter warned Ethicon of the potential dangers of morcellators and their ability to spread undetected cancer. Johnson & Johnson withdrew its morcellators from the market last July.
Johnson & Johnson claims that after their conversation with Lamparter, they added new language to the instructions of the device. In patients where a cancer is suspected, doctors are told to use a special bag to remove the tissue.
Dr. Lamparter believes this change to be a “legal fig leaf” and claims that the gynecologists at his hospital, Evangelical Community Hospital in Pennsylvania, reported that training they received from the company did not change after Lamparter’s warning was made.
A Johnson & Johnson spokesman, Ernie Knewitz, says the company was unaware of any investigation.
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