In late July, Johnson & Johnson announced it would recall its three morcellator devices. Morcellators are used during laporoscopic surgeries, utilizing tiny blades to break apart tissue so it can be removed through the small incisions. This procedure has been widely used to remove uterine fibroids (myomectomy) or to remove the uterus (hysterectomy).
In this case, Johnson & Johnson moved much faster than the FDA, and has now recalled its three devices only three months after the FDA issued its first warning that use of the devices may cause the spread of the cancerous tissue, leiomyosarcoma.
Certain risks have been known about the procedure since its first use in the 1990s, but those risks appear to have been underestimated. Last year a Boston doctor who now faces a near-certain terminal cancer diagnosis brought the issue to light – and now more reports are coming in linking use of the device with a worsening of a cancer prognosis.
Some former critics praised Johnson & Johnson for its swift action on the morcellator. Dr. Diana Zuckerman, with the public health advocacy group National Center for Health research, told the New York Times, “The company has had an 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.”
A University of Michigan business professor, Erik Gordon, has also previously been critical of the company. He said about the morcellator recall: “This is one of those things where it’s enough up in the air that you might have expected Johnson & Johnson to say, well, we’re going to keep it on the market because the evidence in inconclusive. But that’s not what they did.” Prof. Gordon suggested the early action on morcellators may have been affected by the company’s earlier and costly mistakes on metal hip implants and pelvic mesh devices.
Recent history on product recalls
Metal hip replacements – Last fall, J & J agreed to pay $2.5 billion to settle claims for about 8,000 patients who had used the company’s all-metal hip implants, which subsequently had to be replaced. The company stopped making the device in 2009 and recalled it in 2010.
The company did not act so quickly in that arena, with internal documents suggesting that J & J management was aware of problems with the device at least as early as 2008. Current data now shows that more than one-third of the implants will fail within five years, whereas hip replacements are typically expected to last 10 – 20 years.
That settlement was one of the largest for a medical device. The implant failures not only caused patients to endure replacement surgeries but also injuries as well, with metal leeching out and damaging the surrounding tissues and bone.
Pelvic Mesh Lawsuits – J & J is currently facing more than 30,000 pelvic mesh lawsuits from patients enduring pain and serious injury for the product that was marketed to treat urinary incontinence and other conditions. J & J took that product off the market in 2012.
A spokesperson for the Ethicon unit of Johnson & Johnson told the New York Times that the early recall on the morcellators was not affected by the company’s problems with these other devices, stating, “Every situation is unique and evaluated independently of each other.”