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Boston Scientific indicates that it is prepared to unveil a new medical device that will make the removal of uterine fibroids safer than power morcellators, which have been linked to an increased risk of spreading cancer during laparoscopic hysterectomy and myomectomy procedures.
In a press release issued on November 17. Boston Scientific announced that it will unveil the Symphion System, a hysteroscopic tissue removal system, which will allow doctors to remove uterine fibroids without posing a risk of sending unsuspected sarcome contained within the uterus throughout the body.
The system is being described as an alternative to power morcellators, which are medical devices used in recent years to perform laparoscopic surgery for uterine fibroid removal, allowing surgeons to cut up the tissue through a small incision in the abdomen. The minimally invasive procedures were promoted as a superior surgical method, reducing the risk of complications associated with a traditional hysterectomy and shortening recovery time.
In recent months, concerns have emerged about the risk that power morcellators may spread leiomyosarcoma or cancerous tissue that some women have hidden within their uterus.
About one out of 350 women undergoing uterine fibroid removal have unsuspected sarcoma, which doctors are unable to diagnose or detect before the procedure. Most experts have recently begun to abandon power morcellators, determining that the risk of spreading cancer exceeds the benefits provided by the minimally invasive procedure.
The new system is described as a bladeless bipolar RF plasma resection device. A lack of blades could mean less chance of tissues that may contain cancerous cells being ground up and spread through the body cavity. Boston Scientific plans to unveil the system this week at the American Association of Gynecologic Laparoscopists (AAGL) Global Congress in Vancouver, British Columbia.
According to the company, the first U.S. patients were recently treated with the device.
Power Morcellator Cancer Risks
In April, the FDA warned doctors that power morcellators should not be used to remove uterine fibroids, due to the risk of doctors unintentionally spreading cancer that may be contained within the fibroids.
An FDA advisory panel met over the summer to reviewed the link between power morcellators and cancer, concluding that there is no way to reduce the risk of the devices spreading leiomyosarcoma or other forms of uterine cancer.
Following the hearings, an Ethicon morcellator recall was issued by the manufacturer, after the company decided to stop making the devices since there does not appear to be a way to make them safer. While Johnson & Johnson’s Ethicon subsidiary controlled more than 70% of the U.S. market for power morcellators, other manufacturers have not followed suit.
Many law makers and patient advocates are calling for the FDA to ban power morcellators, but some within the medical community have resisted the efforts, arguing that the benefits of the minimally invasive procedures should not be underestimated.
It appears that the new Boston Scientific device designed for hysteroscopic removal of uterine fibroids without posing the same cancer risks may allow regulators to recall morcellators without limiting the availability of minimally invasive procedures.
Morcellator Cancer Lawsuits
As more families throughout the U.S. learn that leiomyosarcoma or other uterine sarcoma may have been spread during a hysterectomy or myomectomy, a growing number of morcellation cancer lawsuits have been filed, alleging that manufacturers of the medical devices knew or should have known about the risks, yet continued to aggressively promote uterine fibroid morcellation, potentially sacrificing the small percentage of women with unsuspected sarcoma.
Plaintiffs claim that they never would have agreed to undergo a laparoscopic hysterectomy instead of an traditional treatments for uterine fibroid removal if they knew that power morcellators may cause the rapid spreading aggressive cancer, greatly shortening their life-expectancy and overall quality of life.
Other alternative treatment options have been available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy 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.