NEW BRUNSWICK, NJ—The U.S. Food and Drug Administration (FDA) last month upgraded its April warning regarding a controversial device used in common fibroid surgeries called a laparoscopic power morcellator.
The stronger warning for the drill-like device comes almost six months after Johnson & Johnson (J&J), the world’s largest morcellator manufacturer, voluntarily suspended worldwide sales and distribution of its power morcellators and pulled them from the market.
In the recent advisory, the FDA is finally saying that power morcellators can spread undetected cancer. The agency now requires that all morcellator manufacturers immediately update their product labels to include a "black-box" warning.
Hooman Noorchashm, an outspoken cardiac surgeon who has spearheaded a campaign against the use of the tool in hysterectomies, told NBToday that the Medwatch Report he filed, from his wife’s bedside, in December 2013 prompted the FDA to issue its very first warning on the surgical tool exactly four months later.
His wife, Amy Reed, now a stage 4 cancer patient, is a victim of the high-tech surgical technique that Noorchashm argues is flawed.
Of J&J’s response to the April FDA warning, the issuing of a voluntary worldwide recall on its line of morcellators, Noorchashm told NBToday that the move was a “perfect first step,” but more needs to be done.
Noorchashm told NBToday what he thought J&J’s next step should be: “The next good step is for them to explain to the American people, and to United States senators why it is and how it is that when they knew this was a problem they did not report it back to the FDA.”
“Did they not think this was a complication? Did they not think this was a problem? Or were they just comfortable making money and sort of marketing a product that consultants were saying is a good thing?” he asked.
“The next step has to be a congressional hearing. A lot of people have died,” said Noorchasm.
He says that J&J's Ethicon unit was warned about the deadly problems associated with morcellation as early as 2006 by Dr. Robert Lamparter, a Pennsylvania pathologist.
A report in the Pittsburgh Business Times reads: “It was eight years ago when the multinational giant [J&J] was sent an email from a Lewisburg doctor suggesting prescreening for cancer is not always effective prior to uterine surgeries.”
“I believe there’s more risk to this procedure than J&J realizes because of the way Community Hospital gynecologists are screening patients,” wrote Lamparter, then a pathologist at Evangelical Community Hospital, according to the report.
“Our pathology group agrees that at least once in a year’s time we find an unexpected malignancy in a uterus that takes a gynecologist by surprise.”
“Virtually all uteruses have some sort of pre-op screening, whether it’s an endometrial biopsy or an ultrasound, so whatever screening is being done misses a certain number of malignancies,” Lamparter continued, according to the report.“When the operative procedure is a standard hysterectomy, no damage is done. If a morcellation is done, the patient’s survival is jeopardized.”
Noorchasm says that J&J has a major problem with both corporate ethics and corporate responsibility.
“It isn’t just that they were warned – [J&J] knew because they put it in the footnote in their manual,” he says, asking: “Why didn’t they report this back to the FDA?”
Noorchashm says that J&J opted not to inform the FDA about the problem or take any steps to halt the marketing and use of the product, as they should have in 2013.
“It’s great to have a corporation that’s good for business and good for the economy and creates a lot of jobs, but at the same time, there has to be a certain degree of corporate ethics that goes into their behavior.”
“How could they be putting out a product that is causing cancers to be upstaged – marketing it worldwide – without reporting the problem they know of to the FDA?” said Noorchashm, speaking of the eight-year period from 2006-2014.
Noting that many women have died prematurely or unnecessarily, Noorchashm said: “Based on real cases and substantive epidemiological evidence, hundreds if not thousands of women world-wide have had their cancers upstaged using J&J morcellator's for nearly two decades.”
“Most of these women did not even really understand what happened to them.”