The drama surrounding power morcellators continues to heat up, with a federal lawmaker raising questions over whether Johnson & Johnson and Brigham & Women’s Hospital failed to notify the FDA of risks posed by the devices, used to treat uterine fibroids.
Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee, addressed the issue during a Nov. 17 hearing, maintaining J&J “was apparently aware of the dangers of this device as early as 2006, based upon a report from Dr. Robert Lamparter, a pathologist from central Pennsylvania, who cited about one out of 300 samples of morcellated tissue from his hospital had evidence of a hidden cancer.”
Murphy made his comments in a hearing on the regulation of diagnostic tests and laboratory operations, during which Jeffrey Shuren, head of the FDA’s device center, testified. When Murphy asked whether the hospital had reported these findings to the FDA, Shuren replied that he wasn’t aware of what actions the healthcare facility took.
Power morcellators have received a lot of scrutiny over the past couple of years, particularly related to the cancer link.
Earlier this year, the Federal Bureau of Investigations launched an investigation after cardiac surgeon Hooman Noorchashm, of Philadelphia, reported that his wife’s cancer spread throughout her body following a morcellation procedure at Brigham & Women’s Hospital in 2013 ().
Morcellators, which have been on the market for more than 20 years, are used to shred tumors.
The FDA issued a safety alert for the devices in April 2014, and in November of that year warned against their use in most women undergoing myomectomy or hysterectomy for treatment of fibroids.
Also, Brigham & Women’s Hospital was aware of the dangers in 2012, Murphy pointed out. A patient named Erica Kaitz was seriously injured in 2012 by the device and then died in 2013, Murphy said.
Shuren said hospitals and manufacturers are required to report certain events to the FDA, adding, “What I can tell you is that we have been looking into those concerns that have been raised.”
The FDA’s safety alert said morcellator blades could spread unsuspected cancers in as many as one in 350 cases.
However, Murphy pointed out the FDA has admitted that the one out of 350 risk does not address other types of malignancies, which would add to that risk.
Also, the FDA identified studies showing that morcellated patients had worse outcomes than those who had not undergone morcellation, added Murphy.
Shuren responded, “In terms of tests we looked at, we think where we have constrained it right now for use is where the benefits outweigh the risks. But we are continuing to look at new data as it arises and if so, we will act accordingly.”
Earlier this year, a bipartisan group of lawmakers called on the Government Accountability Office to investigate the FDA over morcellators, saying the agency, industry and many gynecologists had pointed to the risk of a hidden cancer as being only 1-in-10,000 ().
The GAO has accepted the request, and the work is set to get under way in January or February, agency spokesman Chuck Young tells IDDM.
Brigham & Women’s Hospital declined to comment. J&J did not respond to a request for comment by press time. — Jonathon Shacat