Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, CA.
Division of Female Urology, Department of Urology, Stanford University School of Medicine, Stanford, CA.
Menopause. 2020 Sep 28;28(2):135-141. doi: 10.1097/GME.0000000000001661.
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.
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.
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%).
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.
能量设备作为一种微创治疗方法，已在医学和美容领域得到广泛应用，用于治疗包括女性生殖泌尿系统综合征、阴道松弛、压力性尿失禁、性交困难以及外阴疾病（如苔藓疾病和外阴前庭炎）等多种盆底功能障碍。然而，美国食品药品监督管理局（FDA）最近发布声明，警告患者和医务人员，能量设备治疗阴道症状的安全性和有效性尚未得到充分证实。此外，FDA 还向能量设备制造商发出通知，称其可能违反了 FDA 的营销标准。目前关于副作用的数据有限，仅限于观察性研究。因此，我们试图通过分析 FDA 制造商和用户设施设备体验（MAUDE）数据库中的监测数据，对阴道能量设备的安全性事件进行特征描述，特别关注 2018 年 7 月 30 日警告发布之前发生的事件。
2013 年 9 月 30 日至 2019 年 10 月 31 日，我们在 MAUDE 数据库中检索了所有阴道能量设备的相关数据。报告了这些设备的安全性事件发生率，并对最常见的投诉进行了描述和特征分析。我们还分析了 2018 年 7 月 30 日之前和之后的事件报告。
共检索到 42 份独特且相关的医疗器械报告（MDR）。Mona Lisa Touch 的 MDR 报告数量最多（40.5%），其次是 ThermiVa（16.7%）和 Viveve（14.2%）。每份医疗器械报告都与单个患者的经历相关，在这 42 份医疗器械报告中，共有 85 起投诉。大多数 MDR 投诉（52.9%）也是能量设备治疗的适应证，包括阴道疼痛、性交困难、硬化性苔藓和尿频。三分之二的投诉（68.2%）与疼痛有关，但严重不良事件（如三度烧伤）很少见（3.5%）。大多数可报告的事件发生在 2018 年 7 月 30 日之前（83.3%），但大多数报告发生在 2018 年 7 月 30 日之后（78.6%）。
MAUDE 报告的数据表明，大多数阴道能量设备治疗后的患者投诉包括阴道疼痛、膀胱疼痛和泌尿系统症状。本研究表明，大多数投诉并不严重，有些可能与疾病的进展有关。MAUDE 数据库中报告的少数严重不良事件可能是 FDA 发布关于能量设备警告的原因之一。在 FDA 警告之后，由于召回偏见以及潜在的诉讼，在 2018 年 7 月 30 日之后，不良事件报告可能会增加。
