FDA Issues Sharp Warning on Hysterectomy Devices, But No Ban

Tuesday, November 25, 2014

Since April, when the FDA opened an investigation into the safety of power morcellators used in more than 60,000 yearly hysterectomies and myomectomies, consumer advocates have been waiting to see if the agency would ban their use.

Today, FDA officials answered those questions with a harsh warning against use of the devices, but stopped short of issuing a full ban.

Officials now state that most women who undergo a hysterectomy or fibroid removal should avoid a laparoscopic procedure with a morcellator. They also recommend against their use in women who are near or past the age of menopause, who have suspected cancerous cells, or who can have vaginal procedures instead.

The new advisory requested that makers of morcellator machines add warnings to be given to all women who are considering a procedure with the device.

Morcellators are used in laparoscopic surgeries to limit the incision site and tie required for recovery. They became a stalwart in hysterectomies and fibroid removal surgeries in the past decade due to the ease of use for surgeons and smaller scars for patients.

However, the ultra-thin blades that allow such small incisions can produce deadly results: if a patient has undetected cancer tissue, the mincing of tissue for easier removal can spread the cells to otherwise healthy tissue nearby.

In April, the FDA cited a study by Columbia University that showed 1 in 350 women who have hysterectomies or myomectomies may have undetected uterine cancer. And, there is no way to find it before surgery.

In July, the agency gathered a panel of experts to study the issue deeper, which led to today’s decision.

The FDA advisory is to take effect immediately. However, it may prove moot as the largest manufacturer of the machines, Johnson & Johnson Ethicon, has recalled them.

Already, they and other manufacturers face hundreds of lawsuits from women who developed uterine cancer after undergoing a hysterectomy.

If you’ve been affected in a similar way, DrugNews can connect you with a lawyer specializing in morcellation cancer lawsuits today. Call or email for more information or an immediate legal evaluation of your case.

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