Vaginal Energy-based Devices: Characterization of Adverse Events Based on the Last Decade of MAUDE Safety Reports

Shannon L. Wallace, MD; Eric R. Sokol, MD; Ekene A. Enemchukwu, MD, MPH

Disclosures

Menopause. 2021;28(2):135-141. 

In This Article

Results

Between September 30, 2013 and October 31, 2019, 42 unique medical device reports associated with laser and energy-based device treatment for PFDs were retrieved. Each medical device report was associated with a single patient experience and within the 42 medical device reports, there were 85 complaints. The Mona Lisa Touch had the highest number of MDRs (40.5%) followed by ThermiVa (16.7%) and Viveve (14.2%) (Table 1).

According to the MDRs, the most common indication for laser and energy-based device treatment was "vaginal rejuvenation" (Figure 1). Five reports listed two indications for treatment (vaginal dryness and urinary incontinence, dyspareunia and urinary frequency, vaginal rejuvenation and urinary incontinence, vaginal pain and urethral pain, vulvar pain and urinary incontinence) and one report listed three indications for treatment (vaginal atrophy, dyspareunia, urinary incontinence). Most reports were submitted by patients, although 14.3% were submitted by the manufacturer and 2.4% by healthcare professionals.

Figure 1.

Indications for energy-based procedures.

Interestingly, a majority of the MDR complaints (52.9%) were actually listed as indications for energy-based devices procedures in other MDRs, which included vaginal pain, dyspareunia, lichen sclerosis, and urinary frequency (Figure 2A). While one patient may have had an energy-based device procedure for dyspareunia, another patient may actually have reported dyspareunia as a complication. Eleven MDR complaints were also indications for an energy-based device procedure in the same patient (Figure 2B). Two-thirds of the complaints (68.2%) were related to pain. Thirty-five percent of patients reported vaginal pain, vulvar pain or vaginal burning, 12.9% complained of dyspareunia and 15.3% complained of bladder or urethral pain (Figure 2C). Up to 8.2% of all MDR complaints were related to urinary tract infections, yeast infections or bacterial vaginosis, and could be addressed with antibiotics or medical therapy (Figure 2D). Four patients reported vaginal numbness (4.7%) and three patients reported vaginal bleeding (3.5%) (Figure 2E). Five of the 85 complaints (5.9%) were not likely related to an energy-based device procedure including Bartholin's gland cyst, blurry vision, eye irritation, and facial pain (Figure 2F). Serious adverse events such as third-degree burns (3.5%) were rare (Figure 2C).

Figure 2.

Characterization of MDR complaints. (A) Characterization of MDR indications and complaints for energy-based device procedures. Forty-five (52.9%) of the 85 MDR complaints were also indications for energy-based device procedures. (B) Concurrent MDR indications and complaints for energy-based device procedures. Eleven (12.9%) of all 85 MDR complaints were also indications for energy-based device procedures in the same patient. (C) MDR complaints related to urogenital pain. Fifty-eight (68.2%) MDR complaints were related to urogenital pain. (D) MDR complaints treated with medical therapy. Seven (8.2%) MDR complaints were treated with medical therapy. (E) Nonpain related MDR complaints. Fifteen (17.6%) non-pain related MDR complaints. (F) MDR complaints unrelated to energy-based device procedures. Five (5.9%) MDR complaints unlikely related to energy-based device procedures.

In evaluating the impact of the July 30, 2018 FDA announcement, we analyzed the number of events that occurred prior to this date and then number of events that were reported after this date. Most of the reportable events occurred before July 30, 2018 (83.3%), but most were reported after July 30, 2018 (78.6%) (Figure 3A, B). Of the events that were reported before July 30, 2018, 89% of them involved pain-related complications, including all three reports detailing the third-degree burns.

Figure 3.

Time-line of 42 medical device reports (MDR). (A) Medical device events that occurred before and after July 30, 2018. (B) Medical device reports that were reported before and after July 30, 2018.

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