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Health/Medical
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Title: Don’t try to rejuvenate your vagina, FDA warns
Source: Ars Technica
URL Source: https://arstechnica.com/science/201 ... arns-after-scolding-companies/
Published: Jul 31, 2018
Author: Beth Mole
Post Date: 2018-07-31 09:35:44 by Willie Green
Keywords: None
Views: 823
Comments: 2

Ouch —

The FDA notes that the “energy-based” therapies are unproven and can cause serious harm.

The Food and Drug Administration is cracking down on companies “deceptively” marketing unproven “vaginal rejuvenation” devices and treatments that have been reported to cause serious burns, scars, and chronic pain, the agency announced on Monday, July 30.

In addition to warning consumers, the FDA revealed that it has taken action, sending warning letters to seven companies marketing “energy-based” devices that are being used outside of their cleared or approved intended uses. Some of the devices, which are commonly radiofrequency- or laser-based, have legitimate uses such as removing warts or pre-cancerous vaginal or cervical tissue.

But, the agency notes, there’s no proof that these devices are effective for any of the “rejuvenating” procedures companies claim and some celebrities promote. These include empowering-sounding treatments that claim to tighten tissue, relieve pain, and boost sexual pleasure. More specifically, the companies collectively claim that the devices are able to treat vaginal “laxity,” pain during urination or intercourse, decreased sexual sensation, and vaginal dryness, itching, or atrophy. Some of these issues are symptoms related to menopause, urinary incontinence, or sexual function issues.

In a twitter thread Monday, FDA Commissioner Scott Gottlieb noted that some of the companies specifically targeted patients who had undergone breast cancer treatments and were experiencing symptoms from early menopause.

“Deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb fumed in one tweet.

Gottlieb went on to note that the agency has reviewed patient reports and medical literature and found “numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain” from the treatments.

“We’re deeply concerned women are being harmed by these procedures,” he added.

The FDA plans to monitor and follow up with the companies, as well as look into ways to revamp its oversight of such medical devices. For patients, the FDA suggests discussing any vaginal issues with your doctor.

The seven companies called out by the FDA are: BTL Industries, Inc; Cynosure, Inc.; Alma Lasers; Sciton, Inc.; Thermigen, Inc.; BTL Aesthetics; and Inmode MD Ltd.


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#1. To: Willie Green (#0)

Exactly how is your vagina coming along, Willie?

no gnu taxes  posted on  2018-07-31   9:44:51 ET  Reply   Trace   Private Reply  


#2. To: Willie Green (#0) (Edited)

I won't. I promise. Even if I wanted to, and paid for it, she wouldn't let me. Keeps saying it's not my vagina.

People who could only get government jobs ...................

Hank Rearden  posted on  2018-08-01   18:20:21 ET  Reply   Trace   Private Reply  


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