FDA Strengthens Warning on Medical Devices (Morcellators)
Posted on: December 4th, 2014 by Richard Cuthbert
On November 25, 2014, the Food and Drug Administration (“FDA”) regulators strengthened the warning on a common gynecologic surgical device known as a morcellator. Since April 2014, the FDA discouraged morcellation for uterine procedures warning that morcellators may spread occult cancer in the course of fibroid removal. Before strengthening the warning on November 25, 2014, the FDA approved dozens devices for laparoscopic power morcellation. The FDA now suspects that nearly 1 in 350 patients, that are undergoing these procedures with morcellators, are at risk for having unsuspected uterine sarcoma, which can have major life altering consequences, including death.
What is a Morcellator?
A morcellator does exactly what it sounds like . . . it morcellates – it cuts tissue into tiny pieces or morsels. Think of the morcelator as a “mini mincer,” a drill with a very long, hollow bit, and a blade on the end. The doctor inserts the mini mincer in the patient’s abdomen to access the uterus. The doctor then blasts away at the uterus, chopping it into fine pieces and sucking those pieces up through the hollow tube.
According to the Society of Gynecologic Oncology, morcellation was developed as a minimally invasive procedure to reduce the size of an enlarged uterus so that it may be removed through two small laparoscopic incisions or through a woman’s vaginal canal — rather than the traditional and more invasive open hysterectomy surgery.
The Problem With Morcellation
The problem with morcellation is straightforward once you understand how the morcellator works. Occasionally, some of the minced bits of (morcellated) tissue are not sucked up through the tube, leaving them scattered in the body. The problem arises when the scattered tissue contains cancerous cells, creating the potential for these cancerous cells to spread cancer throughout the body.
Findings have shown that these minced bits of cancerous tissue can promote the spread of a rare, and deadly, form of uterine cancer. As a result, several manufacturers have suspended the production of morcellators. Many hospitals have also banned morcellators until the risks are more fully evaluated. In fact, Johnson and Johnson has since completely suspended selling their entire line of morcellation devices (the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator).
Bottom Line About Morcellation
Be wary of power morcellation surgery for uterine procedures. If you have had this procedure in the past, get checked out. Once uterine cancer takes hold and spreads, it is difficult to stop.
If you have undergone this technique for a uterine procedure and now have cancer, give Cuthbert Law Offices a call at 1-804-733-3100 or contact us online. We are available 24 hours a day for emergencies and we do not charge anything just to sit down and talk.