On July 30, 2016, Johnson & Johnson announced that it would pull its power morcellation devices from the global market. This comes after the company suspended sales of the surgical tool in April 2014 after the FDA issued an advisory warning linking morcellators to the spread of cancerous tissue throughout a woman’s uterus, pelvis, and abdomen. Ethicon, a Johnson & Johnson subsidiary, will issue a letter to customers to discontinue use and return the devices.
The device works by shredding uterine fibroids, allowing a woman to receive treatment without the need for invasive surgery. However, when these pieces of tissue are not completely removed, they can migrate throughout the body, spreading potentially cancerous tissue and significantly decreasing the patient’s chance of long-term survival, especially patients with a previous history of uterine cancer.
Johnson & Johnson previously defended the safety of its product, but said that it was awaiting a decision from the FDA. The FDA estimates that the device is used in around 50,000 surgeries each year.
The risk of spreading cancerous tissue in the body was widely believed to be so small (1 in 10,000) that most doctors didn’t even mention it to their patients. Now, the medical field has begun reevaluating that risk after a high-profile case in Boston. The FDA has now said that women undergoing a procedure to remove uterine fibroids have a 1 in 350 risk that the growths are malignant. Use of power morcellation devices to shred potentially cancerous cells can cause the cells to spread to other areas of the body.
Ethicon plans to voluntarily remove power morcellators from the market because of its link to the spread of undetected cancer, which can be aggressive and difficult to treat and which cannot be detected before the procedure. As more women and families learn of the risks associated with myomectomy and hysterectomy procedures done with a power morcellator, people are questioning whether Johnson & Johnson made the product as safe as they could have and whether they provided adequate warnings.
There are currently numerous pending lawsuits against Ethicon brought by individuals who have been diagnosed with endometrial stromal sarcoma or leiomyosarcoma after surgery in which a power morcellator was used. If you or a family member has received a cancer diagnosis after a surgery involving a morcellator, do not delay in speaking to an attorney about your legal rights. Contact Bartimus Frickleton & Robertson, P.C. today to talk about pursuing compensation for your losses.