[125347610]
I was encouraged to have treatment using the btl elixis ultra femme 360 by my gynaecologist's office ((b)(6) women's health) to help with my urinary stress incontinence. During an initial consult at (b)(6), i was given btl marketing material which claimed that it helps with urinary stress incontinence. The midwife/dr who i met with confirmed this to be true. I paid (b)(6) upfront ((b)(6) for each treatment). I was told each treatment should be 7 days apart and that i would need to come back for an annual maintenance treatment which would cost (b)(6). I underwent three treatments. My dr had people in the room who they were training watch each of my procedures which was uncomfortable and worrisome because it was obvious i was one of the first pts they had used the machine on. My first appt was on (b)(6) 2018. When i went for my second treatment on (b)(6) 2018, after sitting in the office for an hour, the appt needed to be cancelled because they couldn't figure out which attachment to use. At this point, i was feeling very apprehensive and expressed that i was worried they didn't know what they were doing. I was also upset that the next available appt would be almost 2 weeks from the first when they said they should be done weekly. I was told that i could not get my money back because i had begun treatments and that it was fine to go as 3 weeks in between. They did end up refunding (b)(6) for the inconvenience. My second appt was on (b)(6) 2018. The 3rd appt was on (b)(6) 2018. Each treatment was done differently but the 3rd treatment given by dr (b)(6) was done on totally different areas and when i mentioned this to her, she told me it was fine and it would still work. I was unaware that the fda had issued warnings regarding the btl, ultra femme 360 until (b)(6) 2018. When i called (b)(6) to inquire about this, i was told that they will no longer offer the treatments and that everyone who had one or two treatments was fully refunded (b)(6). They told me that i was not refunded because i had completed the recommended three treatments. I explained that i would never have spent (b)(6) dollars on a treatment that was not fda approved and that i could not maintain because they no longer offer it and that i wanted a refund. The woman i spoke to told me that i could get maintenance treatments, just not through them and that she would have dr (b)(6) call me about my concerns and refund request that day. She never called. Since then, i have gone on the landing page for the ultra femme 360 on the btl website and received a pop up window which indicated that the website was not intended for us customers, so they are clearly no longer marketing it for vaginal rejuvenation in the usa and maintenance treatments are not an option. My urinary stress incontinence symptoms have already returned and i feel totally taken advantage of and ripped off. I had no idea that the device was only fda approved for the treatment of wrinkles. I am scared that the device could have caused internal damage and i want to be kept aware of any future developments that come out through the fda's investigation of these devices that were being improperly marketed towards women with health conditions like mine. I also would like to know if there is any way to get my money back.
Patient Sequence No: 1, Text Type: D, B5