A communication from the U.S. Food and Drug Administration indicates that women who went through a vaginal rejuvenation process might not be aware of the associated dangers. The devices used for vaginal rejuvenation could be unsafe and could come with significant side effects, according to the FDA.

According to new complaints, women who underwent a vaginal rejuvenation process have reported side effects that may have been worse than what they were led to expect. Women who went through this vaginal rejuvenation process without a proper warning about the possible risks may qualify to join a free lawsuit investigation.

The vaginal rejuvenation process is promoted to women who have menopausal or sexual symptoms or those women who are suffering from urinary incontinence. The Food and Drug Administration released a safety communication over the summer, advising women and their treatment providers that the agency has not evaluated the devices used in these treatments for safety and effectiveness when they are used for these treatments.

The vaginal rejuvenation devices use radio frequency or laser waves and were FDA-approved for the purpose of treating pre-cancerous cervical tissue and vaginal tissue as well as genital warts. However, their use to treat other problems, such as vaginal itching, laxity, and dryness have not been approved by the FDA. Furthermore, the FDA says it has not approved them for use in treating problems such as painful urination, painful intercourse, and decreased sexual sensation.

Many of the problems reported with these treatments include vaginal burns, recurring and chronic pain, scarring, and continued or new pain during sexual intercourse. Many different companies involved in creating and promoting the devices used in vaginal rejuvenation treatments have been notified by the FDA about potentially inappropriate marketing.

The FDA is currently evaluating next steps in relation to vaginal rejuvenation treatments and claims that many of these companies have been engaged in improper marketing of devices for unapproved uses, which could cause some patients to suffer unnecessary injuries due to not knowing the risks or from failing to get assistance with recognized or appropriate therapies to treat medical conditions.

More than a dozen adverse event reports have already been filed with the Food and Drug Administration about damage linked to the vaginal rejuvenation process.

Many of the women who have reported these vaginal rejuvenation issues may not have been warned about the dangers in advance of getting the procedure, and the FDA believes that these companies may need to do more to notify potential patients about the risks, so that they can make an informed decision about what is in their best interests. If you or someone you know needs assistance following a vaginal rejuvenation process, you may qualify to participate in a free vaginal rejuvenation lawsuit investigation.