To reduce the spread of cancerous tissue during fibroid removal and hysterectomy surgeries, Johns Hopkins University has announced it will no longer use power morcellators on women over the age of 50. Under the so-called “Hopkins Protocol,” morcellation will also be contraindicated in women who have risk factors for gynecologic cancer including tamoxifen use, pelvic radiation and hereditary cancer syndromes.
Free Morcellator Cancer Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the morcellator and we can help.
What’s the Problem?
Under the university’s new guidelines, morcellation may only be performed on qualified women by high-volume surgeons who use endoscopy bags to catch tissue spills. Endometrial sampling and imaging tests – including an MRI to look for uterine fibroids – must be performed to rule out undetected sarcomas, and women must be warned of the cancer risk before undergoing surgery.
“Given the review of our institutional data and recent national debate surrounding power morcellation, our institution developed the protocol to enhance safety for women [undergoing] minimally invasive surgery for benign indications,” said Dr. Stephanie Ricci, a gynecologic oncology fellow at Hopkins.
The new protocol was announced just days before the U.S. Food & Drug Administration (FDA) issued an updated warning on power morcellators, advising surgeons to avoid using the devices on peri- or postmenopausal women, and when tissue can be removed en bloc either vaginally or by mini-laparotomy, which is the case with most hysterectomies and myomectomies. Women must also be warned of the cancer risk before surgery, FDA said on Nov. 24.
Hopkins developed its protocol based on a review of 424 morcellation surgeries performed at the university between 2005 and 2014. Two patients who underwent the procedure were subsequently diagnosed with occult cancers, giving an incidence of 0.47%.
Taken together, the Hopkins protocol and the FDA’s new guidelines could help better clarify the narrow pool of women for whom power morcellation might still be a viable option, be it to preserve fertility or for some other health reason.
Do I Have a Morcellator Cancer Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in laparoscopic power morcellator lawsuits. We are handling individual litigation nationwide and currently accepting new morcellation cancer cases in all 50 states.
Free Morcellator Cancer Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a Morcellation Cancer Suit and we can help.