A surgeon whose wife’s cancer was morcellated and hence spread and made more aggressive, has said the morcellator represents a national security threat from the FDA. The surgeon said this threat is greater than the one from [so-called] ISIS. He also said that gynecologists are corrupting basic surgical principles by using morcellators on fibroids without first screening them for cancer.
Thousands injured by Morcellation
Morcellators do present a greater national security threat to Americans than the shadow government-funded “terrorists” of ISIS. One study has found that some 1 in 350 women has cancer when she is operated on with a morcellator for a hysterectomy or uterine fibroids. The morcellator greatly compounds the cancer problem. Disturbed sarcomas are not only spread but also made more aggressive when morcellated. The morcellator has been used for 20 years. If, as estimated, some 200,000 women are morcellated yearly, and 1/350 of those has cancer, then some 600 women yearly face a greater risk of having their cancer spread and made more aggressive. That means some 12,000 American women may have been injured or killed by morcellators. That tragic result has led to morcellator lawsuits being filed across the country.
Dr. Noorchashm and Dr. Reed
Dr. Hoonan Noorchashm, a cardio thoracic surgeon in Philadelphia, Penn., is married to Dr. Amy Reed, an anesthesiologist and surgical intensive care physician. The couple has six children. In Oct. 2013, their lives changed forever, after Dr. Reed underwent laparoscopic surgery for hysterectomy. Surgeons found leiomyo sarcoma that was not benign. The couple asked their gynecologist surgeon, “Did you get it all in one piece?” The response was, “No, I’m sorry. We morcellated it.”
That was the beginning of a very long journey that culminated in Dr. Noorchashm’s testifying before an FDA advisory panel meeting in 2014 (see video below) to call for the banning of power morcellators. Dr. Reed has since had lung surgery, back surgery, and chemotherapy for her cancer. The cost of her care has been at least $500,000 and counting. . .
The proper surgery for sarcoma is to get it all in one piece. Cancers in the uterus or anywhere else can drip and spread if a surgeon uses a morcellator, which is exactly what happened in Dr. Reed’s case.
Wall Street Journal Connection
Dr. Noorchashm has said he was fortunate to be able to speak with a Wall Street Journal editor. He pointed out that not every citizen has the capacity to do so, that most would simply go home, go bankrupt (medical bills are the leading cause of bankruptcy), and die.
Dr. Noorchashm and Dr. Reed have since become outspoken patient advocates. They readily admit that had they not had the experience of seeing up close and personal how the FDA works (or doesn’t), they would likely have never done anything about the problem of devices being unleashed on the public without proper testing. Dr. Noorchashm now says that an informed consent form is a legal device designed to protect doctors. When he spoke out against the morcellator, he was told by the companies making it that he would have lawsuits served against him. He was shocked to find that not one single company had reported an adverse event to the FDA before his wife’s case. He points out that gynecologists bill each morcellator operation at $30,000.
Morcellator Problems unreported
“I’m astonished that these gynecologists are reporting that only now are they noting this problem,” he says. “How was this not reported?” he asks the FDA advisory committee in the video (below). “This is a systemic practice. It’s not safe. It’s not responsible. . . this is a group of surgeons committing industry-wide negligence.”
Mincing up Tumors a Surgical Corruption
Dr. Noorchashm says that mincing up potentially cancerous tumors inside a woman’s body is “a massive corruption of surgical technique. A mainstay of surgical therapy of sarcomas is unblocked dissection with good margins. That is basic surgery. Gynecologists have corrupted that.”
Sacrificing Minority for Majority
Dr. Noorchashm takes umbrage with the notion that morcellation is good for the majority.
“Where in this society have we accepted the sacrifice of a minority subset of women for the benefit of the majority?” Dr. Noorchashm asks the FDA panel with mounting outrage. “What is that number we’re going to accept? One in 350? Is it one in 1,000? Is it one in 500? (These) surgeons have built this device and trained a whole generation of surgeons to mince up tissues inside of a woman’s body. Is this a safe and logical device? Is this something you want your own mother, sister, wife, daughter to be subject to?
“The only categorization this device requires, now, is banned, unsafe, illogical, incorrect, unacceptable and deadly.” His voice quivers with emotion while two of his six children flank him. Dr. Noorchashm continues, “ I’m sickened that these gynecologists are incapable of seeing what they do. It is collective blindness. It has happened in history before. And you don’t have to go back to far in history to see that whole groups of people could be blind to fundamental error in judgment.
“These 30 women (in the gallery) are real. The Wall Street Journal proved that.” Dr. N read the names of the 30 who were fighting sarcomas unleashed throughout their bodies by a morcellator.
Morcellator National Security Threat
“Congressional leaders are good at talking about threats to national security, threats that are 6,000 miles away. They have hearings about it all day. This (the morcellator) has killed hundreds of Americans. This has wasted billions of dollars of our resources. You tell me, which is a greater national security threat. ISIS or an FDA-approved morcellator, or the 510(k) legislation? I appeal to your common sense.”
The doctor also pointed out that there’s no definitive way to diagnose sarcoma, to screen women before using a morcellator on them. He pointed out how in general surgery morcellation is considered an arcane practice that most general surgeons have abandoned. He said a gynecologist, by contrast, “gets zero days in general surgery. They don’t get a liberal general surgical education.”
FDA a Mission-Corrupted Agency
The FDA dramatically failed in not banning the device, says Dr. Noorchashm. (The agency has indicated that it frowns on or questions the practice.) For analogy, he used a can of soup. He said that if a can of soup had deadly results in one out of every 350 people, they would take it off the shelf. Morcellators are still on the shelf. Though the FDA has discouraged their use, Dr. Noorchashm believes that is far from enough.
“The FDA is a mission-corrupted federal agency,” says Dr. N. It has deviated from its public health mission in favor of streamlining life saving devices to market. That is a marketing mandate, he says, not one made for safety.
“You cannot have a federal agency not speaking for people who are in harm’s way. Because lobbyists are well fed, well dressed, well rested. Patients who get harmed go home, they go bankrupt, and they die. They don’t lobby. It’s the job of the federal government to protect these folks, and the (government) is miserably failing.”