The U.S. Food & Drug Administration (FDA) is advising women who are considering vaginal rejuvenation to avoid energy-based laser treatments whose goal it is to treat symptoms such as “vaginal laxity, vaginal atrophy, dryness, or itching, pain during sexual intercourse, pain during urination, decreased sexual sensation.” These procedures have not been well-studied, and could result in adverse health consequences, including severe vaginal burns and scarring, FDA said.
Free Confidential Lawsuit Evaluation: If you or a loved one had problems after vaginal rejuvenation surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the vaginal laser treatment and our lawyers can help.
What is Vaginal Rejuvenation?
“Vaginal rejuvenation” refers to a family of cosmetic medical procedures intended to treat vaginal dryness, itching and laxity, according to MedScape. None of these procedures have been approved by the FDA as acceptable uses for Cynosure lasers, and using them in these capacities may increase the risk of serious side effects including severe vaginal burns and scarring. The lasers also have not been approved to treat sexual dysfunction (i.e. decreased sexual sensation, pain during intercourse, or urination).
“We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal ‘rejuvenation’ and/or cosmetic vaginal procedures,” FDA said. “The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.”
What is the Cynosure Laser?
The family of Cynosure lasers work to treat a variety of skin and hair conditions. The machines were designed for the following applications:
Cynosure Elite MPX – Dual wavelength cosmetic machine used to treat skin conditions including hair removal, skin tightening, scar reduction and vascular treatments. The device combines 2 different lasers, the 755 alexandrite (for light-skinned patients) and the 1064 Nd:Yag (for dark-skinned individuals). Both lasers are optimized for treating pigmented lesions and vascular lesions.
Cynosure Apogee Elite – Works on collagen stimulation in a variety of skin rejuvenation treatments including wrinkle reduction, skin tightening, laser facials, leg veins, acne, facial veins, and lesions. This Apogee laser system is capable of removing hair on all skin types and offers dual-wavelength (both an Alexandrite and Yag laser), which enables practitioners to treat patients with a variety of skin types.
What’s the problem?
The fear is that Cynosure lasers and other similar products are being marketed directly to menopausal and breast cancer patients without undergoing adequate safety studies, or having received approval from the U.S. Food & Drug Administration (FDA) for these cosmetic purposes. Due to the way these devices are being marketed for unnecessary (non life-threatening) purposes, women who need actual medical treatment might be more susceptible to falling for these treatments.
Can I File a Cynosure Lawsuit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against Cynosure, the maker of laser devices being marketed for unapproved and under-studied cosmetic procedures, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving medical devices allege that a product was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of vaginal rejuvenation laser treatments, our attorneys suspect that patients may be able to take legal action in light of claims that Cynosure and other manufacturers failed to adequately warn doctors and patients about the risk of vaginal burns and scarring.
Do I Have a Cynosure Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Cynosure lawsuits. We are handling individual litigation nationwide and currently accepting new vaginal rejuvenation injury cases in all 50 states.
Free Case Evaluation: Again, if you suffered complications from a laser vaginal rejuvenation treatment, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.