MORCELLATOR

A power morcellator is a medical device used in laparoscopic surgeries, such as splenectomy, gall bladder removal, and hysterectomies. The device is inserted into the body through a small incision and then is used to remove large tissue sections by dividing the sections into smaller pieces or fractions. The surgical tool is designed to facilitate the removal of tissue through small incision sites and is an alternative to a traditional abdominal incision surgery. A traditional abdominal incision surgery is a much more invasive surgery, with a longer recovery time and more complications, and would leave a large scar.

The FDA approved morcellators in 1993, under the 510(k) process. The FDA indicated the device with a gynecologic use. In 1991, a non-power version of the morcellator received FDA approval.

In 2006, Dr. Robert Lampartar, a pathologist, sent a letter to Johnson & Johnson warning the company that the devices “may lead to dissemination of malignant tissue” and asked that Johnson & Johnson should consider the risk of continued use of morcellators. Johnson & Johnson added a labeling precaution in the use instructions, but did not issue any widespread warnings.

On April 17, 2014, the FDA issued a warning letter stating that the use of power morcellators may spread cancer when used to remove fibroid tumors. The FDA estimated one in 350 women undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. The FDA also estimated that one in 500 have a particularly deadly kind of cancer called leiomyosarcoma. If power morcellation is performed on women with either kind of cancer, there is a risk that the cancerous tissue will be spread within the abdomen and pelvis, and 25 to 65 percent of the time the morcellation significantly worsens the odds of long-term survival. After the FDA letter was issued, Johnson & Johnson suspended sales of the three types of morcellator models manufactured by its subsidiary, Ethicon.

In July 2014, the FDA Advisory Committee concluded that surgeons who use power morcellators should make additional efforts to inform patients about the risks of cancer associated with use of the device. The FDA also suggested adding serious warning statements to the product packaging, and increasing the classification of morcellators to Class III category, which requires new manufacturers to present proof of safety and efficacy through extensive clinical studies. FDA is also considering other steps, including adding a black box warning to the labeling of the device.

Also in July 2014, the Journal of the American Medical Association published a study that showed an increased uterine pathology following morcellator use; uterine pathology are tumors found in the corpus, cervix, vaginal canal, broad ligament, and ovaries. Ethicon issued a voluntary recall of their devices shortly after this study was publicized because of the "uncertainty" of cancer.

Following the FDA’s advisory and American Medical Association study, some hospitals and medical centers have discontinued the use of power morcellators. These hospitals and medical centers include Boston Medical Center, Brigham & Young Women’s Hospital, Tufts Medical Center, Cleveland Clinic, the University of Pennsylvania Health System, and Massachusetts General Hospital. In addition, several insurance companies decided to limit coverage of uterine morcellation in light of the potential risks to the patients’ safety. Some of the insurance companies include Blue Cross-Blue Shield of Massachusetts, Harvard Pilgrim, Fallon Health, Highmark Inc., and UPMC.

In the lawsuits that have been filed, the plaintiffs claim that the manufacturers of the devices knew of and failed to warn patients and the medical community of the increased risk of cancer development after power morcellator use. Plaintiffs also claim that the companies failed to make the devices safe for their intended use, by failing to properly design the devices and conduct adequate testing. The companies that are named as defendants in the lawsuits are Ethicon (a subsidy of Johnson & Johnson), LiNA Medical USA, Blue Endo, Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI.