Abstract and Introduction
Abstract
Objectives: Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning.
Methods: The MAUDE database was queried between September 30, 2013 and October 31, 2019 for all vaginal energy-based devices. The incidence of safety events was reported for these devices and the most common complaints were described and characterized. Event reporting was analyzed before and after July 30, 2018.
Results: Forty-two unique and relevant medical device reports (MDRs) were retrieved. The Mona Lisa Touch had the highest number of MDRs (40.5%) followed by ThermiVa (16.7%) and Viveve (14.2%). Each medical device report was associated with a single patient experience and within the 42 medical device reports, there were 85 complaints. A majority of the MDR complaints (52.9%) were also indications for energy-based devices procedures, which include vaginal pain, dyspareunia, lichen sclerosis, and urinary frequency. Two-thirds of the complaints (68.2%) were related to pain, but serious adverse events such as third-degree burns (3.5%) were rare. Most of the reportable events occurred before July 30, 2018 (83.3%), but most were reported after July 30, 2018 (78.6%).
Conclusions: MAUDE-reported data suggests that the majority of patient complaints after vaginal energy-based device treatment include vaginal pain, bladder pain, and urinary symptoms. This study suggests that the majority of complaints are not severe, and some may be related to progression of the disease. The few severe adverse events reported in the MAUDE database may have contributed to the FDA warning regarding energy-based devices. Recall bias after the FDA warning, as well as the potential for litigation, may have prompted an increase in adverse event reporting after July 30, 2018.
Video Summary: https://links.lww.com/MENO/A650.
Introduction
Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders (PFDs) including genitourinary syndrome of menopause (GSM), vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis.[1–8] Available management options for the treatment of pelvic floor disorders include pelvic floor physical therapy, topical creams, hormone therapy, and reconstructive surgical procedures.[9] While many of these treatment options can significantly improve symptoms, each treatment modality differs in efficacy and carries a unique set of challenges and potential side effects.[10–12]
Energy-based device vaginal therapy offers the option of a short, minimally invasive office-based procedure requiring two to five treatments given in 6-week intervals with once yearly maintenance therapy and minimal recovery time. There are two major types of energy-based vaginal devices—laser devices and radiofrequency devices.[13] Laser devices, such as fractional CO2 laser systems and Erbium:YAG lasers, use beams of light to induce collagen and elastin formation.[14–16] Radiofrequency devices use energy to heat tissue and stimulate subdermal collagen production and increase local fibroblast activation.[17]
The United States Food and Drug Administration (FDA) has granted FDA 510 (k) clearances to several energy-based devices for incision, excision, and vaporization of body soft tissues and, in the field of gynecology, this includes the treatment of abnormal or precancerous cervical or vaginal tissue and condylomas. However, the FDA has not cleared energy-based devices for the treatment of GSM, urinary incontinence, sexual dysfunction, or vaginal rejuvenation.[18] Of note, FDA-cleared medical devices have received an FDA 510 (k), which is a premarket submission to demonstrate that the device to be marketed is safe, effective, and substantially equivalent to a legally marketed device. FDA-approved medical devices have undergone the premarket approval process, which involves scientific and regulatory review by the FDA and a much more stringent evaluation of safety and efficacy.
On July 30, 2018, the FDA issued a statement expressing concern over the marketing of energy-based devices to treat conditions and symptoms related to menopause, urinary incontinence, or sexual function. The FDA claimed that there was a lack of adequate evidence to support their use for these non-FDA-cleared indications and criticized the manufacturers for deceptive marketing of these products. Each manufacturer received a "It Has Come to Our Attention" Letter (IHCTOA Letter) from the FDA which requested additional information about the promotion of these devices and a warning about possible violation of the Federal Food, Drug and Cosmetic Act (FD&C).[19] The FDA cautioned these manufacturers that promotion of these products in this manner may violate FDA standards and could lead to significant adverse events in patients.[20]
The goal of our study was to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning.
Menopause. 2021;28(2):135-141. © 2021 The North American Menopause Society
