For the past several months, DrugNews has reported on growing concerns that power morcellator devices used in many hysterectomies could spread uterine cancer.
Since April, the FDA has launched an investigation and advised doctors of potential risks. The largest manufacturer of the devices has also stopped selling them for the time being.
Now, however, the doctor that started the public awareness campaign over hysterectomy device cancer dangers could face legal action from a company that isn’t happy about the prospect of losing sales.
Last year, Dr. Amy Reed, an anesthesiologist from Massachusetts, learned that she had advanced stage uterine sarcoma after undergoing a hysterectomy. Since then, she and her husband Dr. Noorchashm have warned of the risks of power morcellators.
Morcellation devices allow doctors to perform laparoscopic surgeries with much smaller incisions than normal, speeding recovery times, reducing scars and limiting the risk of infection after surgery.
However, the tiny blades can also spread tissue as they cut. The FDA has warned that as many as 1 in 350 women that undergo the procedures could have undetected uterine cancer, which can be substantially accelerated.
Dr. Noorchashm’s campaign included writing letters to other doctors, health regulators and the manufacturers of the devices themselves, asking that they be pulled from the market.
In July, Johnson & Johnson, the largest maker of power morcellators, announced they would no longer sell them. However, German manufacturer Karl Storz is not happy about all the negative attention.
Karl Storz made the device used in Dr. Reed’s fibroid removal. Now, they have written Dr. Noorchashm demanding that he stop warning of cancer dangers and blaming them for his wife’s case.
He says he will continue to warn the public about morcellators, and push for an end to their usage.
Lawyers have also begun filing lawsuits against morcellator makers on behalf of those affected by cancer. Until recently, no one warned patients of this serious risk.
Lowes, R. Morcellation Critic Dares Device Maker on Lawsuit Threat. MedScape. (September 4, 2014). Retrieved from http://www.medscape.com/viewarticle/831267#2
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.