Johnson and Johnson Recalls Power Morcellator
Johnson & Johnson pulled its power morcellator from the global market. The company’s Ethicon later issued a worldwide letter to customers to return power morcellator tools, which slice up uterine tissue into smaller pieces so it can be removed in minimally invasive surgery.
The company already suspended sales of the surgical tools in April following an FDA advisory warning which linked the tool to the spreading of dangerous cancer cells in women. Spreading of these cancerous cells can significantly decrease a patient’s chance of long-term survival, especially for those who have a previous history of uterine cancer. At the time Johnson & Johnson defended the safety of the tool, but said it was waiting for a definitive decision from the FDA.
While the risks of cutting up cancer inside the body were long known, the risk that a woman with presumed fibroids actually had sarcoma was widely believed to be so small—1 in 10,000—that most gynecologists rarely even mentioned it to patients.
But after a high-profile case in Boston, the medical field began re-evaluating that risk. In April, the FDA said women undergoing surgery for fibroids have a 1 in 350 risk that the growths are actually cancerous. Power morcellators could spread undetected tumorous cells into the abdomen and pelvic region. Before the advisory warning was issued in April, the FDA estimated that the device was used in about 50,000 uterine surgeries each year.
The FDA has not issued a definitive decision yet on the morcellator’s future. But Johnson and Johnson’s Ethicon subsidiary plans to initiate a voluntary market withdrawal because of the tools risk in spreading aggressive forms of uterine cancer which doctors are not able to diagnose or detect before the procedure.
As women and families learn that cases of aggressive uterine cancers diagnosed following a laparoscopic hysterectomy or myomectomy may have been caused by morcellation, questions are being raised about why adequate warnings were not provided and whether manufacturers failed to make the device as safe as it could have been.
Uterine fibroid morcellation lawsuits are now being pursued on behalf of individuals diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other cancers following a surgery performed with a power morcellator.
If you or a loved one have been diagnosed with cancer following a surgery involving a power morcellator, please contact the law offices of Goza & Honnold at (913) 451-3433. You may be entitled to compensation for related injuries.