By Katie Thomas, The New York Times
July 31, 2014
Johnson & Johnson, which has come under withering criticism for its response to problems with some of its medical devices, won cautious praise from critics on Thursday for its decision to withdraw three products used in uterine surgery because of a risk of spreading cancerous tissue, only months after the safety issue became widely known.
Some experts continued to debate the medical value of the devices. A handful of other, smaller companies sell similar products.
The Ethicon unit of Johnson & Johnson said Wednesday that it was asking hospitals to return three types of power morcellators, devices that are commonly used in uterine surgery to remove fibroids by cutting the tissue into tiny pieces and extracting them through small incisions. In April, the Food and Drug Administration recommended that doctors stop using the procedure after the agency concluded that the risk of spreading cancer was higher than previously thought. That led Johnson & Johnson to announce that it would suspend sales and marketing of its products while it studied the issue, but it stopped short of withdrawing them from the market.
In a letter sent to health care providers, Ethicon asked that hospitals return three models of power morcellators made by the company: the Gynecare Morcellex and Gynecare X-Tract tissue morcellators, as well as the Morcellex Sigma tissue morcellator system.
About 50,000 operations a year involve power morcellation of tissue containing fibroid tumors, according to the F.D.A.
Some critics said they were pleasantly surprised that Johnson & Johnson acted as quickly as it did. “The company has had a rather abysmal track record on the public health front of ethical breaches in the last few years, so this is good that they’re doing this,” said Diana Zuckerman, president of the National Center for Health Research, a public health advocacy group that has criticized the company in the past over its safety record, especially concerning pelvic mesh implants. Dr. Zuckerman owns stock in Johnson & Johnson and her father, now retired, worked for many years in quality control at the company. Speaking of the decision on the power morcellators, she said, “At least it goes back to an earlier time when the company was seen as doing the right thing.”
The move comes as some in the gynecology field continue to disagree about the usefulness of power morcellators. Although the risk of spreading cancer through this procedure has been previously known, it was long believed that the chances for spreading cancer were lower, ranging from 1 in 10,000 to 1 in 500. In April, the F.D.A. concluded that the risk was closer to 1 in 350.
Still, some doctors cautioned against vilifying the procedure, saying that power morcellation allows minimally invasive surgery that, if carefully done, can be a better choice for some women. Without morcellation, more women will have to undergo serious abdominal surgery, which carries the risk of infection, bleeding, pain and blood clots. “These are things that people also die of,” said Dr. Barbara Goff, director of gynecological oncology at University of Washington. “So my concern is that we aren’t looking at this in balance.”
Mr. Gordon and others wondered whether Johnson & Johnson may have moved more quickly in this case after previous product recalls and withdrawals led to billions of dollars in legal settlements and bad publicity.
Last fall, the company announced it would pay $2.5 billion in compensation to an estimated 8,000 patients who had to have their all-metal hip implants removed and replaced, and more lawsuits were pending worldwide. Internal company documents from 2011 estimated that the implants would fail within five years in 40 percent of the patients who received it.
Johnson & Johnson is also facing more than 30,000 lawsuits involving its pelvic mesh implants, which it withdrew from the market in 2012. The devices, which treat urinary incontinence and a condition called pelvic organ prolapse, have been linked to pain and serious injuries.
Matthew Johnson, a spokesman for Ethicon, said the company’s decision to withdraw the power morcellators had nothing to do with safety issues involving other products. “Every situation is unique and evaluated independently of each other,” he said.
Johnson & Johnson does not report sales of its power morcellation products. While it dominates the market in power morcellators, they account for only a small share of its total revenue. The handful of other companies that sell such devices did not return calls for comment.
What sets the morcellation issue apart from the pelvic mesh and artificial hip cases, said Dr. Hooman Noorchashm, is the fact that the consequences can be so deadly. Dr. Noorchashm, helped draw national attention to morcellation last December after The Wall Street Journal published an article about his wife, Dr. Amy Reed, who developed advanced cancer last fall after a hysterectomy that used morcellation.
“People are being killed,” he said. “Of course they have to act responsibly.”
Photo credit to The New York Times, read original article here.