Johnson & Johnson (J&J) has halted sales of its fibroid surgery device due to concerns that use of this device may spread undetected cancers.
J&J’s power morcellators, which have been used in laparoscopic surgery for the removal of uterine fibroids, have been suspended from sales worldwide, Reuters reported.
As we posted on our blog earlier this week, Ethicon has been sued by a New York woman who underwent laparoscopic surgery using power morcellators and alleges that this device caused the spread of prior undetected cancers.
Morcellation devices are essentially hollow cylinders tipped with cutting implements that are inserted into a woman during laparoscopic surgery. The surgeon uses the morcellator to grasp, cut and remove a mass of tissue, in order to avoid cutting the patient open with a large incision.
According to OBGYN.net, more than 80 percent of women between ages of 30-50 have uterine fibroids. Laparoscopic myomectomy involves the removal of uterine fibroids with only small incisions and a small viewing instrument and can be a preferred option for women hoping to become pregnant, reports WebMD.
The U.S. Food and Drug Administration (FDA) announced earlier this month that using power morcellators in laparoscopic myomectomy or hysterectomy presents a risk of spreading unseen cancers. Based on available data, the FDA determined that 1 in 350 women undergoing these surgeries to treat uterine fibroids have an unsuspected type of cancer called uterine sarcoma.
According to the FDA, use of these power morcellators to remove fibroids (which could possibly contain cancerous cells, presents a “risk that the procedure will spread the cancerous tissue within the abdomen and pelvis.”
Though J&J was quick to remind customers that this was “not a removal product,” it has suspended sales of its power morcellators until further research is conducted. A spokeswoman for J&J told Reuters that “[J&J is] also reaching out to regulatory agencies around the globe” with regard to its product’s potential link to uterine cancer risk.
By suspending power morcellator sales, it’s likely that J&J is hoping to avoid the fibroid surgery device from becoming the newest defective medical device targeted in the courts. Even though the FDA has warned against the risks of power morcellation for the use of removing uterine fibroids, they remain legal for use by medical professionals.
As we mentioned last week, the scientific journal JAMA has recently published an article expressing concern about the procedure. The problem is that though most fibroids are non-cancerous, a few are malignant. Cutting up malignant tissues into small pieces increases the risk that some of those pieces will migrate to other areas of the body, where they will seed new cancers.
This is exactly what happened to Dr. Amy J. Reed, who developed a rare, aggressive uterine cancer after undergoing morcellation. She has since started a campaign to stop the use of this procedure, “A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma (cancer),” she writes. “This means that every day 2-5 women in the U.S. – and more around the world, will have a deadly cancer spread because of morcellation.”
The JAMA notes that the process “may disperse fragments of undetected malignant tumors throughout the abdominal cavity and upstage otherwise contained cancers.” They go on to state that since it is difficult to detect the presence of these cancerous tumors before the surgery, the procedure may, in fact, “be too risky under any circumstance.”
If you or a loved one underwent laparoscopic morcellation surgery and were diagnosed with a new cancer, you may be entitled to compensation for your pain and suffering. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).
