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Johnson & Johnson has stopped sales of its fibroid surgery device over concerns that its use may spread undetected cancer.
J&J's power morcellators, which have been used in laparoscopic surgery to remove uterine fibroids, have been suspended from sales worldwide, Reuters reports.
What are these devices, and why would they present a cancer risk?
Morcellation devices are essentially hollow cylinders tipped with cutting implements which are inserted into a patient during laparoscopic surgery. A surgeon uses the morcellator to grasp, cut, and extract a mass of tissue, all while avoiding "opening up" the patient with a large incision.
According to OBGYN.net, more than 80 percent of women between 30 and 50 years of age have uterine fibroids. Laparoscopic myomectomy involves the removal of uterine fibroids with only small incisions and a small viewing instrument, and can be a preferred option for women seeking to become pregnant, reports WebMD.
However, the FDA announced earlier this month that using power morcellators in laparoscopic myomectomy or hysterectomy presents a risk of spreading unseen cancers. Based on available data, the FDA determined that 1 in 350 women undergoing these surgeries to treat uterine fibroids have an unsuspected type of cancer called uterine sarcoma.
According to the FDA, use of these power morcellators to remove fibroids (which could possibly contain cancerous cells) presents a "risk that the procedure will spread the cancerous tissue within the abdomen and pelvis."
Though J&J was quick to remind customers that this was "not a product removal," it has suspended sales of its power morcellators until more research has been conducted. A J&J spokeswoman told Reuters that "[J&J is] also reaching out to regulatory agencies around the globe" with regard to its product's potential link to uterine cancer risk.
By suspending power morcellator sales, it's likely that J&J is hoping to avoid the fibroid surgery device from becoming the newest defective medical device targeted in the courts. And while the FDA has warned against the risks of power morcellation in removing uterine fibroids, they are still legal for medical professionals to use.
Women who wish to undergo laparoscopic hysterectomy or myomectomy to remove fibroids should be informed of the risk of J&J's morcellation devices, but they can still be used with a patient's informed consent.
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