bannerHON
img
HONnews
HONnews
img PATIENT / PARTICULIER img PROFESSIONNEL DE SANTE img WEBMESTRE img
img
 
img
HONcode sites
Khresmoi - new !
HONselect
News
Conferences
Images

Themes:
A B C D E F G H I
J K L M N O P Q
R S T U V W X Y Z
Browse archive:
2018: S A J J M A M F J
2017: D N O S

 
  Other news for:
Cosmetics
Surgery
 Resources from HONselect
Don't Believe the Hype on 'Vaginal Rejuvenation,' FDA Says

By Robert Preidt

MONDAY, July 30, 2018 (HealthDay News) -- Despite their growing popularity, there's no evidence that so-called "vaginal rejuvenation" procedures are either safe or effective, the U.S. Food and Drug Administration warns.

The procedures, which use lasers and other energy-based devices to remove or reshape vaginal tissue, claim to treat conditions and symptoms related to menopause, urinary incontinence or sexual function.

But in a statement released Monday, the FDA said it's identified numerous cases of vaginal burns or scarring tied to vaginal rejuvenation, as well as post-procedural pain during sexual intercourse or recurring or chronic pain.

It's true that the agency has "cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or precancerous cervical or vaginal tissue," or genital warts, FDA Commissioner Dr. Scott Gottlieb noted in the statement.

"But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation,' " he added.

"In addition to the deceptive health claims being made with respect to these uses, the 'vaginal rejuvenation' procedures have serious risks," Gottlieb said.

In some cases, women who've gone into early menopause after breast cancer treatments are opting for these interventions, but "the deceptive marketing of a dangerous procedure with no proven benefit, including to women who've been treated for cancer, is egregious," Gottlieb said.

In fact, the FDA recently notified seven device manufacturers about inappropriate marketing of their devices for "vaginal rejuvenation" procedures, he pointed out. The companies are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

They were given 30 days to address the FDA's concerns. If they fail to respond in that time, the FDA said it would consider it's next actions, which could include enforcement measures.

"The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions," Gottlieb said.

"These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options," he explained.

"Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options," he advised.

The FDA will closely monitor reports of problems associated with "vaginal rejuvenation" procedures, and will keep the public informed, Gottlieb said.

He also encouraged women who've suffered problems after such procedures to report them to the FDA's MedWatch program.

More information

The American Academy of Family Physicians has more on genital problems in women.

SOURCES: U.S. Food and Drug Administration, news release, July 30, 2018

Copyright © 2018 HealthDay. All rights reserved. URL:http://consumer.healthday.com/Article.asp?AID=736306

Resources from HONselect: HONselect is the HON's medical search engine. It retrieves scientific articles, images, conferences and web sites on the selected subject.
Methods
Therapeutics
Women
Equipment and Supplies
Tissues
Neoplasms
Pain
The list of medical terms above are retrieved automatically from the article.

Disclaimer: The text presented on this page is not a substitute for professional medical advice. It is for your information only and may not represent your true individual medical situation. Do not hesitate to consult your healthcare provider if you have any questions or concerns. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified healthcare professional.
Be advised that HealthDay articles are derived from various sources and may not reflect your own country regulations. The Health On the Net Foundation does not endorse opinions, products, or services that may appear in HealthDay articles.


Home img About us img MediaCorner img HON newsletter img Site map img Ethical policies img Contact