Colorado residents interested in warnings by the Food and Drug Administration may know that in November 2014 the FDA warned that a device used to break up intrauterine growths might be instrumental in causing cancer to spread. Some insurers, including UnitedHealth, require authorization, without which the procedure is not paid. Others, including Highmark, no longer cover procedures that use the device.
The device is a morcellator, which is a power tool used to break up tissue so the growth, such as an intrauterine fibroid, may be removed using a laparoscope. Morcellation may be used for other procedures such as a hysterectomy. The morcellator minces the uterus or fibroid into smaller pieces enabling the surgeon to remove the organ or growth through a small laparoscopic incision.
The issue with a morcellator’s use is that the tool, according to the FDA, may release cancerous cells from a contained location, such as the uterus, into the abdomen. Once released, the cells may disseminate or spread to other sites within the cavity. In addition, the cells may spread through the blood to other sites in the body.
Despite the risk, morcellators are used routinely. One insurance commentator, speaking to the debate over who should have the last word concerning the use of morcellators, said insurers must now decide if payment will be denied on a limited basis or totally.
If, after using a morcellator, the patient develops intrauterine or disseminated cancer linked to the procedure, the patient may incur financial loss in addition to physical harm. Speaking to an attorney may be helpful. The attorney might examine whether prior knowledge of the procedure’s link to metastasis might point to negligence. The attorney may use this as the basis for a medical malpractice lawsuit against the physician.