It is a common treatment for uterine fibroids but now Johnson & Johnson (J&J) is halting the sale and promotion of its popular surgical device, known as a morcellator, because of fears it could spread a deadly cancer.
Fibroids grow in the uterus of some women. While they are often just benign growths, an estimated one in 350 may be cancer known as uterine sarcoma. The morcellator essentially inserts a tube-shaped blade into small incisions into the uterus to grind up the suspicious tissue but in doing so it may unintentionally spread the malignant cancer.
The Food and Drug Administration issued an advisory on April 17 which discouraged doctors from using the morcellator. The agency will convene an expert committee meeting this summer to look at the issue further.
The Wall Street Journal writes that J&J sent a letter to its customers that it is waiting for any findings from the medical community to determine the future of the morcellation treatment for fibroids.
The procedure is used about 50,000 times a year, according to the FDA. Fibroids are associated with an estimated 40 percent of the half-million hysterectomies performed in the U.S.
The morcellator medical devices were approved in the U.S. using the 510(k) approval process, essentially an exchange of paperwork with no clinical trials required. The company admits that since the J&J approval in 1998 determining whether a suspicious growth is cancerous or not has been a challenge.
Prior to the invention of the morcellator, non-surgical procedures to remove fibroids included ultrasound and the use of drugs.
Last year a Boston area couple went public after the wife and mother, Amy Reed, 41, developed an advanced uterine cancer after her morcellation procedure. She contends in a lawsuit that the procedure worsened her cancer.
J&J markets the morcellator as Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract.
Weighing in is the trade group American Association of Gynecologic Laparoscopists (AAGL) which issued a message to members supporting power morcellators and opposing any restrictions on their use. The American College of Obstetricians and Gynecologists said it’s taking a closer look at the percentage of cancerous uterine fibroids.
Many hospitals and doctor’s offices already have the device in-house and there is nothing in this voluntary suspension that mandates they stop using it but hospitals such as the Cleveland Clinic and Brigham and Womens Hospital have stopped using the morcellators, reports the WSJ. Other companies that produce similar models such as Olympus Corp, Richard Wolf GMbH and Karl Storz GmbH did not respond to inquiries from the newspaper.