Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, May 27, 2015

F.B.I. Investigates: Are Medical Device Adverse Events Reported?


F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored

By DENISE GRADY and KATIE THOMAS MAY 27, 2015
The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators.
The tool, called a morcellator, has rapidly spinning blades that cut tissue into pieces that can be removed from the body through the tiny slits made during minimally invasive surgery. Morcellators have often been used in surgery to remove the uterus, but in some women with undetected cancers they have sprayed malignant cells around inside the abdomen like seeds, speeding the progression of the disease.
The inquiries were first reported on Wednesday by The Wall Street Journal, which said the agents worked out of the F.B.I. office in Newark, N.J.


Celeste Danzi, a spokeswoman for the F.B.I.’s Newark office, declined to confirm the inquiry. “We just don’t comment on the existence or nonexistence of any investigation,” she said.
In an interview with The New York Times, Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, was harmed by the device, confirmed that they had spoken a number of times to an F.B.I. agent from Newark. A retired pathologist from Pennsylvania, Dr. Robert W. Lamparter, also said he had spoken to investigators. Both men declined to name the agent, saying they had been warned that disclosing too much information could interfere with the investigation.
Dr. Reed, 42, an anesthesiologist, had a hysterectomy because of fibroid tumors in her uterus in October 2013 at Brigham and Women’s Hospital in Boston. Fibroids are benign, but they sometimes hide cancer. A biopsy after Dr. Reed’s surgery found a hidden sarcoma, an aggressive type of cancer. The tumor spread, resulting in advanced Stage 4 cancer. Dr. Reed underwent numerous rounds of chemotherapy and radical surgery, but the cancer recurred in March of this year, near her spine, requiring still more surgery.
The couple, who have six children, have conducted a ceaseless nationwide campaign to ban morcellation. Gynecology groups have resisted, saying that sarcomas are uncommon and that morcellation makes surgery less invasive and safer for the majority of women.
In November, the Food and Drug Administration said that morcellators should no longer be used in “the vast majority” of women. But the agency did not take the devices off the market or ban their use.
Dr. Noorchashm said he contacted an agent from the Newark F.B.I. office last fall, because he suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the F.D.A. He said that he and his wife spoke with the agent a number of times over a few months, and that the F.B.I. seemed increasingly interested.
Dr. Lamparter said that he had also recently spoken to the F.B.I., and that the conversation had focused on his 2006 correspondence with Ethicon, the unit of Johnson & Johnson that sold power morcellators. At that time, he warned Ethicon of the potential for the morcellators to spread undetected cancer, according to email correspondence he provided to The Times and other news outlets. Johnson & Johnson withdrew its morcellators from the market last July.
Johnson & Johnson has said that after Dr. Lamparter raised his concerns, it added new language to the instructions for use of the device, and that the company had already recommended that, in patients where a cancer was suspected, doctors should use a special bag to remove the tissue.
In a telephone interview Wednesday, Dr. Lamparter said that he considered the change a “legal fig leaf” and that the gynecologists at his hospital, Evangelical Community Hospital in Lewisburg, Penn., reported that the training they received from the company in using the device did not substantially change after he raised his alarm.
Dr. Lamparter said he initially believed that the morcellator could still be used, but not on women at high risk for cancer. However, he added, “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.”
Ernie Knewitz, a Johnson & Johnson spokesman, said it was unaware of any investigation.

Kate Zernike contributed reporting.

http://www.nytimes.com/2015/05/28/business/fbi-investigates-whether-harm-from-surgical-power-tool-was-ignored.html?emc=edit_tnt_20150527&nlid=50639700&tntemail0=y&_r=0

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