Risk of Morcellator Spreading Uterine Cancer Known for Years: Report
As a growing number of lawsuits are now being filed over the spread of uterine cancer during minimally invasive hysterectomies and fibroid surgery, at least one doctor indicates that he has been warning Johnson & Johnson for years that their power morcellators may be causing the spread of cancer cells.
Power morcellators have been used in recent years during laparoscopic fibroid surgery, allowing doctors to cut up the uterus or uterine fibroids and remove the tissue through a small incision on the abdomen. However, the FDA recently warned doctors that the devices may spread uterine cancer for women with unsuspected sarcoma.
According to an exclusive report published last week by the Pittsburg Business Times, Dr. Robert Lamparter, a pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania, indicates that he told Johnson & Johnson’s Ethicon subsidiary about the cancer risks with power morcellators as early as 2006. However, it was not until just recently that the manufacturer announced that they are halting production and sales of the devices.
The Pittsburgh Business Times obtained letters and e-mails between Dr. Lamparter and Dr. David Robinson, who was at that time the medical director of Ethicon Women’s Health and Urology. Dr. Lamparter asked Ethicon to reconsider the cancer risk to women from power morcellation, and Robinson told Lamparter that the company added a warning to instructions for doctors on how to use its power morcellators. However, most doctors and patients did not learn about the risk until the FDA warnings were issued in April, and thousands of women have had aggressive cancers being spread without being informed about the risk.
After determining that about 1 out of every 350 women who undergo a laparoscopic hysterectomy, robotic hysterectomy or myomectomy for uterine fibroid removal may have unsuspected sarcoma, the FDA issued a warning on April 17, indicating that the morcellators should no longer be used due to the risk that spreading cancerous tissue throughout the abdomen may greatly reduce the likelihood for long-term survival. Because there is no reliable way for doctors to detect the uterine cancer prior to the surgery, the FDA urged doctors to avoid uterine fibroid morcellation and to consider alternative surgical techniques.
Following the FDA warnings, many hospitals released statements indicating that they will no longer be performing laparoscopic hysterectomy or uterine fibroid surgery with morcellation.
Johnson & Johnson’s Ethicon subsidiary, which was the leading manufacturer of power morcellators, also announced in April that it was halting sales and distribution of power morcellators until the FDA and medical communities can determine the correct course of action regarding the devices.
The FDA has indicated that it will convene a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss the clinical role of laparoscopic morcellators in treatment of uterine fibroids and whether surgical techniques or the use of accessories like tissue collection bags may make the devices safer. The FDA advisory committee will also review whether new warnings should be placed on all laparoscopic power morcellators regarding the risk of spreading uterine cancer.
Lawsuits Over Uterine Cancer Spread by Morcellation
As women and families learn that cases of uterine cancers diagnosed following a laparoscopic hysterectomy or urterine fibroid removal may have been caused by morcellation, questions are being raised about why adequate warnings were not provided and whether manufacturers failed to make the devices as safe as they could have been.
A number of uterine cancer morcellation lawsuits are now being pursued on behalf of individuals who had leiomyosarcoma, endometrial stromal sarcoma or other cancers spread during the procedures. Plaintiffs allege that as they are currently designed, power morcellators are unreasonably dangerous.
In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.
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