Johnson & Johnson recently announced that it would remove from the global market a device that is used during uterine procedures such as hysterectomies or the removal of fibroids, after reports that the devices could spread and accelerate the growth of cancers inside women. The devices are called power morcellators.
Power morcellators are used to shave tissues or growths into tiny pieces, which can then be removed without open surgery, often laparoscopically or through a tube in the abdomen. However, the masses could sometimes be malignant, and the spinning blades of the morcellators could spread deadly cancerous cells.
In April, the company decided to suspend the use of the devices after the Food and Drug Administration warned doctors that the morcellators could disperse cancerous cells. According to a company spokesperson, the morcellators are now being removed from the market because the risks for women, as well as the benefits for women, are uncertain. The decision was finalized after an FDA meeting earlier this month, at which it was discussed how difficult it can be to diagnose cancer before a procedure is performed. The company decided that until better medical guidelines are established, or new technologies are developed to lessen the risk, the device should be withdrawn from the market.
According to the FDA, about one out of every 350 women who have surgery with a power morcellator may have a type of cancer that the procedure could spread beyond the uterus. If malignant cells are spread by the device to the abdomen and/or pelvis, a woman’s chance of survival can be significantly reduced. The FDA analyzed an insurance database of about 15 percent of the country’s hospitalizations between 2006 and 2012, and found that of about 36,000 patients who had power morcellation, 99 of them were diagnosed later with uterine cancer. Had the cancer been detected prior to the procedure, power morcellation would not have been performed because of the risk of spreading the cancer.
Proponents of power morcellation say that it helps doctors to perform the least invasive procedure available. Without morcellation, women would need to undergo abdominal hysterectomies, which have more complications, larger scars, and larger recovery times. However, opponents to morcellation say that viable alternatives are available, including a vaginal hysterectomy and a mini-laparotomy.
Unfortunately, it’s not uncommon for the manufacturers of medical devices to rush those products onto the market without examining all the risks to patients. In many cases, such as those involving power morcellators, by the time all of the risks are discovered, for many patients it’s too late. In this case, it’s not yet clear how many women had undetected cancerous cells spread throughout their bodies because of the power morcellator. Many of these women will not realize that the cancer could have been detected and contained in one spot, had the morcellator not been used during their medical procedure.
Help is available for individuals who have been injured by defective medical devices. Pharmaceutical companies make millions and billions in profits annually, and out of those profits they are responsible for paying the damages of anyone who has been injured by a defective medical device. This can include past and future medical expenses, time from work, pain and suffering, and compensation for wrongful death.
At Liberty Law, Micha Star Liberty believes that every medical device manufacture owes an extremely high duty to its customers to ensure that the products it manufactures are safe for their intended purpose. If you have been injured by a defective medical product, and you are in the Oakland – San Francisco area, call San Francisco defective medical device attorney Micha Star Liberty at 501-645-1000 or 415-896-1000. She works with clients throughout the Bay area, including Hayward, San Jose, Fairfield, Tracy, and Berkeley. Call today to schedule a free consultation.