Never has the female genital area received so much attention. Changing cultural trends have suddenly exposed this area because of the rise in popularity of the “Brazilian” look. This has led to either a reduced amount of, or no pubic hair at all. The other cultural change for females has been clothing. The “thong” has become a popular form of underwear. Yoga style clothing is very figure forming and tight.
*Please see below for FDA statement from the commissioner Scott Gottlieb, M.D., on efforts to safeguard women's health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for "vaginal rejuvenation"
The following gives a list of procedures and treatments that are available at our MediSpa.
The female genital area consists of two pairs of ‘lips’. The outer lips are thicker. The inner lips are much thinner and extend from the clitoris to the lower vaginal opening. The desired appearance is such that the thinner inner lips should barely protrude beyond the outer lips. If the inner lips are too long, they will extend beyond the outer lips and some women will find this cosmetically unattractive. This can also cause pain or discomfort as the inner lips get caught in clothing or with such activities as cycling.
Labial reduction is a small surgical procedure that reduces the size of the inner lips. It takes about 90 minutes to perform, under local anaesthesia and has quite a short recovery time.
The vaginal tissues, like all our tissues, weaken and lose elasticity. This will often occur after childbirth. Over time, this may also lead to stress urinary incontinence (SUI), which means the loss of some urine with coughing, sneezing or activity.
Vaginal laxity can be treated with the Fotona Intimilase laser. This painless procedure takes about 40 minutes with no recovery time. The laser stimulates a healing process in the vaginal tissues to generate new collagen (this is the same as we do for facial skin tightening). Having this treatment may prevent the development of SUI. Maintenance treatments are recommended.
Pelvic floor laxity is a common outcome of pregnancy and vaginal birth. It can occur for other reasons also, such as chronic cough or occupations that require a lot of abdominal straining. This can be improved with specific exercises that physiotherapists can help with. Some forms of incontinence may need surgery but many can be treated with the Fotona Incontilase laser that strengthens the pelvic floor and vaginal canal to better support the bladder. This also is a painless procedure that takes about 40 minutes and no recovery time is needed. Maintenance every year or two is recommended.
This means pain due to muscle spasm in the vaginal muscles. This may cause painful intercourse or may be bad enough to prevent intercourse altogether. Again, there can be many causes from psychological to back problems. Treatment may involve pelvic physiotherapy and/or treatment of the pelvic floor muscles by injection of Botox into the tight muscles.
The outer lips are comprised mostly of fatty tissue. For many women, as they age, the fatty tissue can be lost, leaving the lips thin and wrinkled. Fillers such as Restylane/Juvederm can be injected into the lips to restore their volume.
The skin in the genital area is really no different to the skin on your face. For labial skin that has lost elasticity, we can do laser or radio-frequency resurfacing. This treatment will require some topical numbing cream to be applied for about an hour prior to treatment. Resurfacing stimulates your own collagen to improve skin quality and elasticity as well as improving skin blemishes such as pigmentation.
This whole change about the genital area has come about as a result of removal of pubic hair. This is commonly done by shaving, trimming or waxing. Although these methods are successful, they can cause stubble, shaving bumps, ingrown hairs and pain. Laser treatment can permanently remove hair leaving the skin soft. Several treatments may be required and the treatments can be uncomfortable. We will apply numbing cream to the area as necessary.
As mentioned, the skin in the genital area is no different to our other skin. We can prescribe topical creams for a wide variety of skin conditions that can affect this area. This could include, for example, lightening creams for reducing pigmentation.
Many women have one or more of their nipples inverted. This means that the nipples do not protrude from the breast. This can cause an undesirable appearance when there is a cavity at the nipple site. This cavity can also become irritated and an unpleasant discharge can sometimes present from this area. Also with more tightly applied clothing, this may not give the desired look to an individual’s appearance. There is a small surgical procedure that can permanently correct this problem. The procedure does, however, transect the milk ducts and so this is not something that should be done if you are planning on nursing an infant.
This procedure was developed by Dr. Charles Runels, Alabama. He was the inventor of the Vampire face lift which is a way of combining fillers like Juvederm and Restylane with PRP (Platelet Rich Plasma) for enhancing facial features and defying the process of aging. He felt that, if this process rejuvenated the facial skin, what could it do in the genital area. The O-shot was developed by Dr. Charles Runels. This treatment is used for the following indications in the female;
• Enhancement of sexual sensitivity and response
• Treatment for Stress Urinary Incontinence (SUI)
• Treatment for vaginal atrophy (dryness) in the menopause
• Treatment for lichen sclerosis (skin changes on the genitals)
It has also had a dramatic effect on SUI (stress urinary incontinence). The injections are almost painless and there is no recovery time at all yet the results can be dramatic. This can also be combined with the laser procedures mentioned above. Dr. Balharry has done the training through Dr. Runels and offers this procedure here at the MediSpa.
What happens during the first treatment?
On your visit for this procedure, we first draw some blood from you (just like having a blood test at the lab). This then goes through a special preparation that takes only about half an hour. This preparation concentrates the platelets in your blood, which are the cells that carry the growth factors and healing cells for repair and regeneration of your tissues. At the same time, you are given some numbing cream to apply to the area to prevent any pain sensation.
The concentrated cells (PRP) are then injected in to a special part of the vagina (the G-spot) and also in to the clitoris. Most women find these injections painless after the numbing cream. The results of increased sensitivity will sometimes happen very quickly, but, as this is basically a healing, or regenerating process, you have to allow 6-8 weeks for a true response.
The big advantage here is that there are no drugs or medications, just using your own blood. The procedure can be repeated if it loses its effect. There is no downtime or recovery time. For menopausal women there is no worry about using vaginal oestrogen. For urinary incontinence, it often stops the need for medications, many of which have quite unpleasant side effects.
For more information, go to www.o-shot.info
All these treatments are done in our MediSpa. Also, there is no one treatment that works for everyone. Often we will do a combination of vaginal tightening with labial reduction and resurfacing. All it takes is a complimentary consultation with Dr. Balharry to discuss your concerns and to help to provide the best option for treatment.
* Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”
For Immediate Release
July 30, 2018
Statement was updated on Aug. 2, 2018 to reflect a correction in the listing of manufacturers that received a letter from the FDA.
Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to meet their health care needs as well as protecting them from harmful products and deceptive medical claims. A large part of our work focuses on efforts to bring forth innovative, new products. But we’re equally dedicated to monitoring the landscape to ensure products are delivering on their intended benefits and to ensure that if new health risks arise, we take appropriate action.
Delivering on this complementary mission is a key aim of our Medical Device Safety Action Plan. The plan outlines how the FDA will encourage innovation to improve safety, detect safety risks earlier and keep doctors and patients better informed. Our plan would establish a robust medical device patient safety net in the U.S. We are taking steps to streamline and modernize how we implement post-market actions to address device safety issues to make our response to risks more timely and effective.
Advancing the health of women is a priority for the FDA. As part of our action plan, we’re working to improve evidence generation about the safety and effectiveness of health technologies in clinical areas that are unique to women. And as part of these efforts, we also watch for, and take action against, bad actors who unfortunately take advantage of unsuspecting consumers by marketing unapproved, deceptive products that may pose safety risks and violate the trust of American consumers.
That’s what we’re doing today.
We’ve recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.
As part of our efforts to promote women’s health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts). But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for “vaginal rejuvenation.” In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.
In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.
We haven’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.
Today, we’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared.
We recently notified seven device manufacturers of our concerns about inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are: Alma Lasers, BTL Industries, Cynosure, InMode, Sciton, Thermigen and Venus Concept. We requested that the manufacturers address our concerns within 30 days. If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate. This matter has the full attention of our professional staff.
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. 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. Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.
We’ve been focused on advancing new policies to improve our oversight of device safety. As part of our Medical Device Safety Action Plan and our ongoing commitment to advancing women’s health, we’ve begun building out important device safety registries. We’ve also established the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.
As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with “vaginal rejuvenation” procedures. We will keep the public informed if significant new information becomes available. We’d also like to learn more about patients’ experiences with these procedures. We encourage those who’ve had an adverse event associated with the use of these devices to report their problem to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.