J&J Suspends use of Blading Procedure in Laparoscopic Surgeries

In late April, Johnson & Johnson announced it was suspending sales of its morcellator device used for laparoscopic hysterectomies and myomectomies. This action came soon after the U.S. Food and Drug Administration issued a safety communication about the device used to remove uterine fibroids. Some are already arguing that J&J should go further and recall the product.

The J&J products being suspended are all sold by its Ethicon division. They are:

• Gynecare Morcellex Tissue Morcellator,
• Morcellex Sigma Tissue Morcellator System, and the
• Gynecare X-Tract Tissue Morcellator

Johnson & Johnson issued a statement saying that it was suspending sales of these devices “while the role of morcellation for patients with symptomatic fibroid disease is redefined by the FDA and the medical community.”

At least one doctor believes J&J should issue a full recall and take the existing potentially dangerous products off the shelves. Dr. Hooman Noorchashm is a cardiothoracic surgeon at Brigham and Women’s Hospital in Boston, Massachusetts. He became aware of the problem after his wife, Dr. Amy Reed, an anesthesiologist, had a laparoscopic hysterectomy with a morcellator in 2013 to remove fibroids. The surgery revealed she had a uterine leiomyosarcoma.

The issue in these situations is that patients have the cancer already, but the blading procedure used to remove it worsens their prognosis by spreading the cancer into other areas of the body.

When Dr. Reed found out the morcellation might have spread the cancer through her abdomen, the couple publicized the issue and launched a debate about the risks of the procedure.  Dr. Noorchashm says that the makers of laproscopic morcellators have known about these risks for years – and he believes the FDA should recall the products if the manufacturers won’t do it themselves.

J&J says that instructions for its morcellators devices have always included precautions about the possible spread of malignant tissue. But a study by specialists at Brigham & Women’s Hospital reviewed the records of more than 1,000 women for whom morcellation was used to remove fibroids; they found the procedure was associated with a nine times higher rate of unexpected sarcoma than is now quoted to patients considering the procedure.

It is possible to reduce the risks that morcellation will spread tissue, which involves encasing the tissue to be removed before it is broken up, however, this process is not frequently used, and few surgeons are trained in the technique.