It is not exactly a recall – but Johnson and Johnson (J&J) has removed from the market its Laparoscopic Power Morcellation, a medical device used to break uterine fibroids into little pieces using a cylindrical blade with a tube to extract the tissue. The problem is in removing a uterine fibroid, one cannot be certain if it is a cancerous tumor. Decimating it into little pieces can spread undetected uterine cancer. The Food and Drug Administration (FDA) did not issue a recall but J&J announced it would suspend global sales after the FDA issued a safety bulletin April 17th.
The story came to light with the case of Amy Reed. The physician and mother of six had a fibroid removed during a hysterectomy and soon developed stage four aggressive uterine cancer known as leiomyosarcoma. She is undergoing six rounds of chemotherapy to fight the cancer.
One in 350 fibroids carry the potential for uterine sarcoma, according to the FDA, and women are generally unaware they have the cancer. According to the American Cancer Society there will be 1,600 cases of uterine sarcoma identified in the U.S. this year.
Alternatives to a power morcellation myomectomy include using a scalpel to remove the fibroids and then contain them in an isolation bag. Abdominal surgery, another traditional mode of hysterectomy, carries an increased risk of injury.
While the latest and greatest “minimally invasive” power tools often impress doctors who hope to impress their patients, hospitals such as Brigham and Women’s Hospital, which operated on Amy Reed, have been begun to restrict use of power morcellation, which is used in just above 10 percent of the 600,000 hysterectomies performed annually in the U.S., according to the American Congress of Obstetricians and Gynecologists (ACOG).
ACOG in a position paper says it is difficult to calculate the risk of morcellating an undiagnosed cancer.
The power morcellation medical device is just another example of a device approved under the FDA’s lax 510(k) approval process that involves a few thousand dollars and an exchange of paperwork. “No clinical trials are performed” says the application. That is how we are finding out too often that the patient population of the U.S. becomes the unsuspecting enrollees of an undeclared and unmonitored clinical trial.