First, we have to mention the latest problems regarding Vaginal Mesh. I am not surprised that the FDA pulled Vaginal Mesh off the market. Though I am trained to do the procedures, I never used a vaginal mesh in my private practice. I used safer and equally efficacious surgeries and procedures where the benefits far outweigh the risks and therefore give patients a better quality of life as well as improvement in sexual gratification.

After years of problems and thousands of patient complications, the FDA mandated that two makers of Vagina Mesh Boston Scientific Corp. and Coloplast Corp. remove their products from the market. The Washington Post and the New York Times recently summarized the following:

The Washington Post (4/16, McGinley) reports the Food and Drug Administration ordered Boston Scientific and Coloplast to stop selling “surgical mesh used for certain pelvic procedures.” Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, said, “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”

The New York Times (4/16, Kaplan, Goldstein) reports that the order “is the most stringent action the F.D.A. has taken in the lengthy legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area.” The Times adds, “In announcing its decision on Tuesday, the F.D.A. said that Boston Scientific and Coloplast…had not demonstrated a reasonable assurance of safety and effectiveness for the devices.” FDA spokeswoman Deborah Kotz “said the two medical device companies had 10 days to submit a plan for how the mesh devices will be withdrawn from the market.”

So, where does it leave the patient with Urinary Incontinence today?

Well at the Center for Sexual Medicine and the Laser Vaginal Rejuvenation Institute – New York, as stated, we have never utilized Vaginal Mesh! We had the foresight years ago to avoid these problems and complications.

We have the latest state-of the-art options, both Surgical and Non-Surgical or Non-Invasive treatments for Urinary Incontinence and related procedures like Vaginal Rejuvenation, HIFEM – Hi Intensity Focused Electromagnetic Technology, PRP – Platelet Rich Plasma and Medical Therapies. Click on all the following options or contact us to educate what is best for you as an individual.

Surgical Options:
Laser Vaginal Rejuvenation with Repair of Urinary Stress Incontinence
Laser Vaginal Rejuvenation for Vaginal Tightening
Combination Laser Vaginal Rejuvenation and Designer Laser Vaginoplasty

Non-Surgical Options or Non-Invasive Vaginal Rejuvenation:
ThermiVa – contracts the vaginal tissues, stimulates collagen production, and improves blood flow and nerve function in a process known a Thermal Neurogenesis.

Orgasm Shot® aka, the O-Shot® – Decreases urinary incontinence, increases sexual desire, arousal, libido, performance and lubrication utilizing PRP – the growth factors from a patient’s own blood.

BTL Emsella therapy – similar to an MRI using HIFEM (High-Intensity Focused Electromagnetic Technology) is becoming a standard for non-invasive treatment of urinary incontinence. Without taking your clothes off, you sit on a comfortable chair, watching TV for 28 minutes and the Emsella unit passively helps you do the equivalent of 11,000 Kegel exercises. Some people call it the “Kegel Throne” It is the latest technology that is FDA Cleared for:
• Male and Female Patients with Urinary Incontinence
• Temporary increase of local circulation
• Increased sensitivity during intercourse

Medical and Bioidentical Hormonal Therapy

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