Risks of Unapproved Vaginal Rejuvenation Procedures

Cosmetic treatments and medical procedures are not just to keep faces looking young. These days, many women are undergoing vaginal rejuvenation procedures to restore tissue to a more youthful state. The U.S. Food and Drug Administration (FDA) has serious concerns about these procedures, however, and warns women that they may do more harm than good.

The vaginal rejuvenation treatments – sometimes referred to as designer vaginoplasty, revirginization, or G-spot amplification – usually consist of three five-minute procedures performed over a period of a few months. A doctor inserts a probe into the vagina, where it radiates laser energy to destroy and reshape the vaginal wall tissue. The laser treatments can be expensive, ranging from $1,800 to $6,000 for the three sessions, and are not typically covered by insurance.

Companies that make the laser devices have marketed them to women as a method of internal and external rejuvenation. In addition to giving women’s genitals a more youthful appearance, they also claim to relieve symptoms of menopause, including dryness, atrophy, urinary incontinence, and painful intercourse.

Some advertising is targeted to breast cancer survivors who have undergone early menopause due to treatment, which can include chemotherapy, radiation, or removal of the ovaries. These patients are typically advised against taking estrogen to manage their symptoms and may seek other solutions.

FDA Voicing Concerns About Women’s Safety

The FDA has approved certain laser and energy-based devices to treat abnormal tissue such as genital warts, ovarian cysts, and lesions, which could lead to cervical or vaginal cancer. They have not approved any laser devices for vaginal rejuvenation procedures, however. The agency claims that there has been no evidence of their effectiveness for this purpose.

Recent studies and adverse event reports have prompted the agency to issue warnings of potential injuries. These can include chronic pain, vaginal burns, painful intercourse, and scarring. The FDA also issued warning letters to seven companies who make the devices.

The FDA is especially critical of the way the laser treatments are marketed; not only are companies encouraging women to seek unapproved treatment that could harm them, but it may get in the way of seeking other therapies that have been proven safe and effective.

Whether they are pursuing treatment for medical or cosmetic reasons, women should understand the full risks of laser vaginal rejuvenation before they make the decision to undergo the potentially dangerous procedure. If a woman suffers an injury caused by one of these laser devices, the company that makes the device may be held financially liable for medical malpractice, as may the doctor who administered the treatment in the event of a surgical error.

New Jersey Medical Malpractice Lawyers at Eichen Crutchlow Zaslow, LLP Obtain Compensation for Victims of Medical Negligence

If you or a loved one has suffered harm due to an unregulated treatment method, call the New Jersey medical malpractice lawyers at Eichen Crutchlow Zaslow, LLP. Our knowledgeable, experienced lawyers will thoroughly review the facts of your case to determine who is at fault for your injury and hold them accountable for their negligence. With offices conveniently located in Edison, Red Bank, and Toms River, we help clients throughout New Jersey. Call us today at 732-777-0100 or contact us online for a free consultation.