The FDA approves the first containment system for morcellation. Plus: ASRM provides guidance for Zika virus. And, the impact of HRT timing and its impact on cardiovascular disease.
The US Food and Drug Administration (FDA) has given the nod to a first-of-its-kind tissue containment system for use with certain laparoscopic power morcellators. Advanced Surgical Concepts Ltd., the manufacturer of the Pneumoliner, is required to warn patients and health care providers that the device has not been proven to reduce risk of spreading cancer during tissue morcellation.
The Pneumoliner consists of a containment bag and tube-line plunger to deliver the abdominal cavity. The tissue to be removed is then placed in the bag and the bag is sealed and inflated. Inflation creates a working space around the tissue and visualization during morcellation to help prevent breakage of the containment bag by the morcellator tip or other surgical instruments.
The device was tested in “worst-case” scenarios and found to be impermeable to substances similar in molecular size to tissues, cells and body fluids. Other testing showed that inflation of the bag provided adequate space for surgeons performing morcellation with good visualization, and under stress testing, it was found to withstand forces in excess of those expected to occur in actual clinical use.
The labeling for Pneumoliner underscores that the device is not to be used on tissue to be morcellated that is known or suspected to contain malignancy. It is also not intended for use on uterine tissue that contains suspected fibroids in women who are perimenopausal or postmenopausal or those who are candidates for en bloc tissue removal. It was approved through FDA’s de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind.
Commenting on the approval, William Maisel, MD, MPH, deputy director for science and chief scientist at FDA’s Center for Devices and Radiological Health said, “This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”
ASRM issues guidance on Zika virus
The American Society for Reproductive Medicine (ASRM) has issued a new document on Zika virus to help providers treat and counsel patients about the disease’s impact on reproduction. Developed under the direction of ASRM’s Zika Virus Guidance Task Force, the information in the report is taken largely from material prepared by the Centers for Disease Control and Prevention and the US Food and Drug Administration.
Key points from “Guidance for Providers Caring for Women and Men of Reproductive Age with Possible Zika Virus Exposure” include:
· Advising women who have Zika virus symptoms to wait at least 8 weeks after symptom onset to attempt to conceive, and men with Zika virus disease to wait until at least 6 months to attempt to conceive.
· An 8-week waiting period also applies to men and women who may have been exposed to Zika virus but who are asymptomatic.
· The same timelines apply to sexually intimate couples using their own gametes in fertility treatment.
· FDA guidance should be followed for donated reproductive tissue. Currently, FDA rules a potential donor ineligible for 6 months following being diagnosed with or having had a high probability of exposure to the virus.
· Advising against routine serologic testing for Zika virus because testing for it is complicated and not universally available.
· Advising those who are in areas of active Zika virus transmission that use of contraception to prevent unintended pregnancy is essential.
· Encouraging providers to counsel and educate patients about Zika and update their informed consent procedures to reflect that counseling.
Timing of HRT and impact on CVD
The cardiovascular benefits of hormone replacement therapy may be more pronounced in women who begin therapy soon after beginning menopause than if they start the therapy a decade after, according to a new study in The New England Journal of Medicine.
Researchers stratified 643 healthy postmenopausal women according to whether they were in early (< 6 years) or late menopause (≥ 10 years). The participants then were randomly assigned to either oral 17β-estradiol (1 mg per day, plus progesterone [45 mg] vaginal gel administered sequentially [ie, once daily for 10 days of each 30-day cycle] in women with a uterus) or a placebo (plus sequential placebo vaginal gel in women with a uterus).
Every 6 months, rate of change in carotid-artery intima-media thickness (CIMT), which was the primary outcome, was measured. Upon completion of the regimen, the women underwent cardiac computed tomography (CT) scanning to assess for coronary atherosclerosis, a secondary outcome.
After a median of 5 years, the effect of estradiol, with or without progesterone, on CIMT progression differed between the early and late menopause groups (P=0.007 for the interaction). In the early menopause group, the average CIMT increased by 0.0078 mm per year among women taking placebo and 0.0044 mm per year in those taking estradiol (P = 0.008). In the late menopause group, the rates of CIMT change were similar for both placebo and estradiol (0.0088 and 0.0100 mm per year, respectively; P=0.29). CT measures of coronary-artery calcium, total stenosis, and plaque did not differ significantly between the 2 treatment groups in either postmenopause stratum.
The researchers concluded that subclinical atherosclerosis was less likely to progress when oral estradiol was started within 6 years of menopause, but no such check in progression was seen when the therapy course was initiated 10 or more years following menopause.