Product Review

FDA and power morcellation, gel for vaginal odor, and an intrauterine electrosurgery system


FDA guidance for power morcellation

On December 29, 2020, the US Food and Drug Administration (FDA) issued an updated safety communication, focused on their ongoing advisement that, when laparoscopic power morcellation is appropriate, only contained morcellation should be performed. Their guidance now points out that uncontained power morcellation has been associated with the spread of benign uterine tissue, which can result in additional surgery. They recommend that health care providers conduct a thorough preoperative screening and, as part of shared decision making, discuss the risks and benefits of all relevant treatment options with their patients prior to undergoing a procedure such as myomectomy or hysterectomy.

“The FDA has granted marketing authorization for one containment system and continues to encourage innovation in this area” said the report. Olympus’ Pneumoliner is the only FDA cleared containment device to provide a laparoscopic option for appropriately identified patients undergoing myomectomy and hysterectomy. The containment system is sold with Olympus’ PK Morcellator, but the company says that it has made the Pneumoliner available to physicians choosing an alternate to the PK Morcellator, provided that there is device compatibility. The Pneumoliner “reduces the spread of benign tissue into the abdominal cavity, in which pathologies, like fibroids, may regrow when tissue or cells are inadvertently left behind,” according to Olympus.

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Vaginal odor elimination gel

Relactagel, a vaginal odor elimination gel, has been clinically shown to maintain a healthy vaginal pH, favoring the growth of lactobacilli bacteria, according its manufacturer Kora Healthcare. These bacteria reinforce the protective acidity of the vagina by producing more lactic acid. Glycogen, also present in Relactagel, compounds existing glycogen stores in the vagina and acts as a nutrient for the lactobacilli.

The gel is sold in 7 single-day applications, with a single tube used per day at bedtime to eliminate unwanted odor. To maintain freshness and comfort, a single tube of Relactagel can be used for 2 to 3 days after a woman’s menstrual cycle, says Kora Healthcare. The company warns that mild irritation can occur with product use during fungal infections or when small tears are present in the vaginal tissue and that use should be discontinued if irritation occurs. In addition, if trying to become pregnant Relatagel should not be used, advises Kora Healthcare, although the gel is not a contraceptive.

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Intrauterine electrosurgery system

Olympus announces that it has acquired the trademark of VERSAPOINT, and is now manufacturing, selling, and marketing the complete intrauterine electrosurgery system—VERSAPOINT II Bipolar Electrosurgery System. The system allows for surgeons to diagnose and treat myomas, polyps, intrauterine adhesions, and uterine septa. Olympus recommends that the Twizzle Tip electrode is ideal for tissue cutting, for septum removals, and endometrial polyp resection. And they say that the Spring Tip electrode should be used for resection or bulk vaporization of a fibroid, as it has a wider vaporizing effect than the Twizzle Tip. Olympus also points out that the VERSAPOINT II Bipolar Generator allows for energy release as needed, ensuring vaper pocket formation. It offers user control during procedures by recognizing default settings for the connected electrode and allowing for customized settings with the dual footswitch, says Olympus.

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