18 Again: Vaginal tightening quackery?

Dec 06 2012 Published by under Uncategorized

When Ultratech India Limited launched 18 Again back in August, this so-called 'vaginal rejuvenation' gel got a lot of press.  The Guardian.  The BBC.  The New York Daily News. Jezebel. Huffington Post.  The Daily Mail.

18 Again wasn't the first product of its kind.  It wasn't even the first vaginal rejuvenation product named '18 Again'.  Little Genie Productions sells a "Vaginal Shrink Cream" called 18 Again, which supposedly helps women "recapture" their "vagina's youth".

Ultratech's 18 Again is not new, so what made it news worthy?  Likely two things - the use of Madonna's 'Like A Virgin' in Ultratech's 18 Again ad campaign and a marketing scheme based on the seemingly antiquated "... idea that women are undesirable beyond virginity."

Ultratech's 18 Again sparked conversation on many fronts - gender, culture, sex, politics...  science?  Most media mentions of  18 Again made no mention of science.  Can a ointment actually tighten the vagina ("revirginize")?  Is it possible that vaginal absorption of 18 Again ingredients will lead to a tighter vagina?

No.  This negative assessment of 18 Again is based on the following review of human anatomy and physiology, as well as an examination of 18 Again's listed ingredients1.

 

Image 1: Female reproductive system

 

 

 

Need a vagina review?  See Emily Willingham's excellent DoubleXplainer: What is the vagina?

 

 

 

 

 

Ultratech makes many claims for 18 Again; below are the claims relating to vaginal tightness.

Tightens and rejuvenates the vagina
The constringent properties of ingredients in 18 Again help in Tightening and Rejuvenating the Vagina. 18 Again helps in improving blood flow to the vaginal muscles, removes dead cells, enhances the growth of new cells and provides a natural moisturising effect.

Improves the grip and strength of the vagina
18 Again improves the tone and strength of vaginal muscles, which helps in strengthening the vaginal grip.

[18 Again website]

Ultratech experts, Dr. Rashmi Saraogi and Dr. R. M. Saraogi (both medical doctors), support Ultratech's claims with statements asserting 18 Again is the best way to achieve vaginal tightening barring surgery.  To see the supposed benefits of using 18 Again, women are instructed to...

 Wash your hands and clean the vagina with water. Open the bottle of 18 Again gel and take a small quantity (approximately 4 to 5 gms) onto your fingertips. Gently insert your finger in the vagina and apply the gel inside the vagina in all directions. Apply twice daily for 3 months along with vaginal tightening exercise as mentioned in the product leaflet.

Image 3

Inserting a finger into their vagina brings a woman in contact with the outmost cells of the vagina's mucosal layer.  Beneath these cells (nonkeratinized stratified squamous epithelium) is the sub-mucosa.  Also called the  lamina propria, the  sub-mucosa contains elastic fibers (collagen, elastin, and reticular fibres), a dense network of blood vessels, along with a lymphatic and nerve supply.  Beyond the sub-mucosa is the muscularis layer, consisting of smooth muscle fibers arranged into an outer longitudinal and inner circular layer.  This arrangement is typical for organs tasked with pushing things through themselves, like the digestive tract and the vagina.  The vagina's third layer - the adventitia - provides major structural support for the vagina, being packed with collagen.  Around the adventitia are three sets of muscle systems that aid in the general muscular strength of the pelvis: (1) ischiocavernosus and bulbocavernosus, (2) transverse perineii and, (3) levator ani.  Muscle, with the help of elastic fibers and collagen, controls vaginal structure and flexibility ("tightness") - not the mucosal layer 18 Again would come in contact with upon application.

Tightening the vagina is done by the vaginal muscles so I don't know how a local cream can do the job. ~ Dr. Nisreen Nakhoda, GP

[Virginity cream sparks Indian sex debate]

 

Image 3: Female anal triangle

 

To gain muscle mass and improve muscle tone or strength, one must do it old fashioned way - exercise.  Muscle development depends on a series of biochemical processes that are kicked-off by the use of the muscle.  Even individuals taking chemicals known to effect muscle development, such as steroids, must exercise to develop that muscular physique they're pursuing.  Steroids do their job when those exercise-provoked biochemical processes do theirs.

Exercise can also strengthen/tone pelvic muscles.  Kegel exercises (instructions below) are regularly recommended to women and men to strengthen the  pubococyggeus (PC) muscle, which is part of the levator ani muscle system (Image 3).

  • Women: Insert a finger into your vagina. Tighten the muscles as if you are holding in your urine, then let go. You should feel the muscles tighten and move up and down.
  • Men: Insert a finger into your rectum. Tighten the muscles as if you are holding in your urine, then let go. You should feel the muscles tighten and move up and down. These are the same muscles you would tighten if you were trying to prevent yourself from passing gas.

[Pelvic floor muscle training exercises from MedlinePlus of the National Institute of Health]

In men and women, the PC muscle supports the bladder and rectum, aiding in urinary and bowel control.  Indeed, Kegel exercises were developed as a physical therapy for physical therapy for urinary and bowel incontinence, as well as sexual dysfunction.   In the area of sexual health, Kegel exercises - via their role in strengthening pelvic muscles - have been recommended as a treatment for orgasm dysfunction.  However, experimental data linking Kegel exercises and orgasmic ability is not conclusive.  In women, the PC is one of the muscles supporting the vagina's third layer, the adventitia.  Kegel exercises, with and without weights, are recommended for women seeking to tone/strength vaginal muscles and prevent/treat vaginal prolapse.

Kegel exercises are mentioned in the FAQ section of the 18 Again website.

12. What are the options for tightening the vagina?
There are three options in isolation or in combination. One is intra-vaginal application of medicaments like 18 Again gel. Second is repeated practice of Kegel exercises. The third is to undergo Vaginoplasty (surgery). The best and safest option is application of 18 Again gel along with the recommended exercise.

32. What is Kegel excercise?
Kegel exercise (named after Dr. Arnold Kegel), is a pelvic floor exercise. It consists of repeatedly contracting and relaxing the muscles that form part of the pelvic floor. Its aim is to improve muscle tone by strengthening the muscles of the pelvic floor and is strongly recommended by doctors worldwide.

The PC muscle will be strengthened if Kegel exercises are done correctly and regularly.  Ultratech's 18 Again, however, will have no effect on vaginal musculature1.

Along with claiming 18 Again will tighten the vagina, Ultratech also claims 18 Again "...helps in improving blood flow to the vaginal muscles...".  The vagina is well-supplied with blood from three sources; vaginal branches of the uterine artery (for the upper vagina closet to the uterus), the inferior vaginal artery (for the middle vagina), and the middle hemorrhoidal and the clitoral arteries (for the distal vagina).  18 Again, applied to the outer layer of the vagina's mucosa, seems as if would have no impact on blood flow to the vagina.

 

Image 4: Uterine and vaginal arteries

 

Examining each of the listed ingredients for 18 Again further supports the assertion that vaginal absorption of 18 Again ingredients will have no effect on vaginal musculature.  This does not mean 18 Again will have no effect whatsoever.  Adsorption of 18 Again by outer cells of the mucosal layer may lead to changes to the cells of that layer.

Below is the list of ingredientsUltratech has provided for 18 Again, along with each ingredient's supposed benefits.

WOODFORDIA FLORIBUNDA
Woodfordia is used as an astringent and has stimulant properties. It acts to contract the walls of the vagina. Its alkaloids provide relaxant and anti-spasmodic effects on uterine lining and blood vascular muscles resulting in increased blood flow.

CENTELLA ASIATICA
Centella Asiatica is used as a vasodilator and blood vessel strengthener. It is known for its effects of generating modulating properties on connective tissues and anti-ageing properties. It has wound healing properties, heals scarred tissues and promotes skin health. Its topical application increases the tensile strength of flesh and tissues. It also helps to promote an increase of haemoglobin and decrease of urea and acid phosphates in the blood.

PUNICA GRANATUM
According to a legend, Punica Granatum grew in the Garden of Eden and the fruit has been used as a folk medicine for thousands of years. More recently, it has been acknowledged as a 'superfood' that can relieve symptoms of many diseases. Punica Granatum fruit extract is a rich source of polyphenols and demonstrates antiviral, antibacterial and incredible antioxidant properties. It is a strong antioxidant, helps to protect tissues from damage, and lowers inflammation in the body.

ALMOND
When estrogens and progesterone plummet; the vagina becomes dry and unhealthy. Almond, as an ingredient in 18 again increases lubrication and prevents vaginal itchiness. Almond is used as an antispasmodic and rejuvenation agent.

ALUM
Alum is a strong astringent and tightens the lax vaginal walls. It is used for vaginal tightening, is a blood coagulant and soothing agent. It also possesses antibacterial properties which helps in fighting vaginal infections that are prone to develop in the ageing tissue.

VITAMIN E
Vitamin E is an excellent antioxidant that prevents tissue damage and promotes cell growth. The topical use of Vitamin E helps overcome vaginal dryness. It is also used to promote the healing of wounds and scars, wrinkles and stretch marks.

ALOE VERA
The gel of Aloe vera is an excellent cleansing agent that helps in cleaning the dead tissues on the skin and helps in the growth of new tissues. It also prevents fungal infections and is a very effective clotting agent. The gel of Aloe vera is used as lubricant and natural moisturizer. It has healing properties and is used in treatment of vaginal infections, allergic reactions, preventing urinary tract infections, scarring and warts. This gel is very helpful in stimulating the immune system.

GOLD
The softest of all metals, gold is a natural product. Gold is a powerful rejuvenator. It strengthens the body immunity and maintains vitality & vigor. Since time began, gold has been used in medicines designed to defy ageing and prolong life! The softest of all metals, gold is a natural product. When applied to the vaginal walls, it influences the walls at a cellular level, giving them new energy, defies ageing related changes and provides rejuvenation. Using gold produces amazing age-defying results that are beneficial for preventative and repairing purposes of the vagina in a very short period of time.

The claims made for the ingredients above are quite varied.  For brevity2, not all of the claims will be addressed in detail.

Image 6: Woodfordia floribunda

The plant Woodfordia floribunda (also known as Woodfordia fruticosa) has a long history in herbal medicine.  In India, this plant is used in both the Ayurvedic and Unani systems of traditional medicine.  In the textile industry, this plant is used as a dye source.  The use of  Woodfordia fruticosa extracts in herbal medicine and textiles is due to a single class of chemicals called tannins or polyphenols.  Tannins tend to be colored and are one of the many types of chemicals that act as astringents.  The property of astringency is why Ultratech states Woodfordia fruticosa "...acts to contract the walls of the vagina."

 

Have you ever sipped a red wine and puckered your mouth?  This is because that wine contains astringent tannins.

Astringents bind proteins on the surface of mucosa cells lining your cheeks, with the astringent-protein complex precipitating (solidifying) along the mucosa. Precipitation changes the structure of the mucosal cells - they pucker (contract) and we pucker at the a sensation called "astringency".

The tannins in red wine do cause the mucosal cells lining your checks to contract, but these tannins do not change the size of your mouth.  Your mouth is just as big - or small - as it was before you drank that red wine.  The mucosal cells lining your cheeks do not control the structure of your mouth.  Similarly, exposing the mucosa of the vagina to an astringent will not alter the structure of a vagina.

Astringents disrupt the normal function and structure of mucosal cells, thus our exposure to them should be limited3.   This does not mean astringents do not have legitimate medical uses.  Sometimes, we need to alter the mucosa.  Sufficient precipitation of astringent-protein complexes along the mucosa creates a barrier, stopping stuff (including more astringent) from going deeper and other stuff (like blood) from leaking out.  Astringents are used to help control bleeding, with one specific example being the use of  alum irrigation to treat severe bleeding of the bladder.

Acute or continued exposure of the mucosa (e.g. mouth, digestive tract, vulva, vagina, etc.) to astringents can irritate the mucosa.   Astringents "dry out" mucosal cells - not the best thing, as these cells often line areas that need lubrication to work optimally (e.g. mouth, digestive tract, vulva, vagina, etc.).  A stringing or burning sensation alerts astringent users that cells are irritated.  These sensations can be quite painful, but astringent users often take a stringing or burning feeling as 'proof' the astringent is 'working'.  The astringent is working, but perhaps not toward the user's intended goal.

Astringents have played a central role in vaginal tightening and "revirginization".

Most of the recipes for tightening and narrowing the opening of the vagina and the tissues of the vulva are astringents, applied topically as baths or poultices and more rarely internally as douches or pessaries.

Hanne Blank, author of Virgin: The Untouched History

Woodfordia floribunda isn't the only astringent 18 Again contains.  Punica granatum (pomegranate) peel, pulp, and fruit contain tannins with astringent properties.  Alum (aluminium potassium sulfate hydrate) is a well-known astringent, featuring prominently in vaginal tightening and revirginization recipes throughout history.   One such recipe, dating back to the 11th century, appears in Autumn Stanley's Mothers and Daughters of Invention: Notes for a Revised History of Technology.

Soaking a soft cloth in a mixture of ground sugar, white of egg mixed into rainwater in which alum, fleabane, and the dry wood of “a vine” have been boiled down with “other similar herbs,” and thoroughly washing and bathing her vagina with this solution.

As with Woodfordia floribunda, Ultratech claims alum will tighten vaginal walls.  Like the tannins in Woodfordia floribunda , alum may cause mucosal cells to contract, but alum will not alter the vaginal musculature4.

Image 7: Pomegranate

Like alum, pomegranate has long history of gynecological applications.  Pomegranate rind is featured in five vaginal suppository formulations for contraception authored by Soranus of Ephesus (98-138 AD).  One such formulation includes both pomegranate and alum.

Moist alum, the inside of pomegranate rind, mix with water, apply with wool.

[Hippocrates' Woman: Reading the Female Body in Ancient Greece by Helen King]

In modern times, pomegranates are best known for being an antioxidant "super food".  It is the antioxidant property of pomegranate that Ultratech highlights in their 18 Again ingredient description.  Pomegranates owe their antioxidant properties to the same chemicals that act as astringents - tannins.  Like most chemicals, tannins pull double (or more) duty.

Antioxidant chemicals inhibit oxidation, a process in which one chemical loses electrons to another chemical (an oxidant).  The oxidant, having gained electrons, is said to be ‘reduced’.  Antioxidants are often described as “stopping free radicals”.  These free radicals are oxidants, which – left unchecked – will oxidize chemicals in cells, changing the oxidized chemical's structure and/0r function.

Free radical damage can change the instructions coded in a strand of DNA. It can make a circulating low-density lipoprotein (LDL, sometimes called bad cholesterol) molecule more likely to get trapped in an artery wall. Or it can alter a cell's membrane, changing the flow of what enters the cell and what leaves it.

[Antioxidants: Beyond The Hype]

Our bodies produce antioxidants (e.g. manganese superoxide dismutase) and we ingest others from our diet (e.g. vitamin E and vitamin C).  However, antioxidant chemicals are not equal.

...big misconception is that antioxidants are interchangeable. They aren't. Each one has unique chemical behaviors and biological properties. They almost certainly evolved as parts of elaborate networks, with each different substance (or family of substances) playing slightly different roles.  This means that no single substance can do the work of the whole crowd.

[Antioxidants: Beyond The Hype]

Diet can be a great source of antioxidants and these chemicals can be beneficial to health, but that does not mean so-called “antioxidant rich” foods are a gastronomical Foundation of Youth.  This year saw a number of companies get sued for over-the-top antioxidant-related health claims.  Hershey for claims made of their Special Dark Cocoa and Special Dark Kisses,  the Dr Pepper Snapple Group for claims made for a number of soft drinks, and  Monavie and Juicey Açai  for açai  juice product claims.  POM Wonderful fell afoul of the Federal Trade Commission (FTC) over health claims it made for its pomegranate juice drinks.

…there was insufficient competent and reliable scientific evidence to support the implied claims in some of the Challenged Advertisements disseminated by Respondents [POM Wonderful], that the POM Products treat, prevent or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, or were clinically proven to do so.

D. Michael Chappell, Chief Administrative Law Judge, FTC

Skepticism is called for when evaluating a product's antioxidant-related health claims - whether that product is a food or a cosmetic5, like 18 Again.

...skin care products containing antioxidants – are they worth the investment? The fact is some work and many do not for a variety of reasons such as packaging and formulation issues.  Antioxidants should be formulated with another antioxidant because they work as a team, meaning they help each other by ‘recycling’ each other. Think of a soccer team, the players need to work together to move the ball across the field. One player cannot do it alone. You need the team of players. The same is true in how antioxidants work; they work most effectively as a team. Thus, skin care products that contain only one antioxidant are not recommended.

[The Skin-y Facts on the Benefits of Antioxidants in Skin Care Products by University of Colorado Associate Professor of Dermatology Theresa Pacheco, MD]

Antioxidant chemicals added to cosmetic may aid in preventing skin damage, but such chemicals are often added to simply preserve the cosmetic.

 Cosmetic formulations contain fragrances, natural fats and oils that can all be subject to auto-oxidation by exposure to air causing off-odors and other instabilities.

Adding antioxidants to the raw material or the formulation is a way to preserve the stability.

[Antioxidants in Cosmetic Formulations from Chemists Corner]

While Ultratech states "...18 Again is a concoction in its precise proportion that works towards providing the most effective rejuvenating and restorative properties within three months", they provide no data as to 18 Again's formulation actually working as an antioxidant once applied as directed.  Indeed, Ultratech provides no data related to any of the claims made for 18 Again on the product website.  This is not to say that for sale in the US such data is required.

"...Cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market.

[Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) from the US Food and Drug Administration (FDA)]

Plant extracts, as sources of antioxidants, are becoming cosmetics mainstays like  vitamin E, almond oil, and aloe vera - all of which are 18 Again ingredients.  Vitamin E, almond oil, and aloe vera can help keep epithelium from drying out - perhaps a good addition considering 18 Again contains astringents.

Image 8: alpha-tocopherol

Vitamin E is not single chemical but a collection of eight chemicals - each an antioxidant.  Vitamin E chemicals are found in a variety of foods, like almonds and spinach, in varying amounts.  The vitamin E chemical present in the largest quantities in our blood and tissues is alpha-tocopherol.  Most vitamin E supplements contain a synthetic version of alpha-tocopherol, as do many cosmetics listing 'vitamin E' as an ingredient.  Vitamin E chemicals are typically added to cosmetics for their antioxidant action, but vitamin E oil is routinely marketed as a stand-alone moisturizer and scar reducing agent.  Ultratech claims "The topical use of Vitamin E helps overcome vaginal dryness" and this may be the case.  The other claims Ultratech makes regarding vitamin E, in light of its topical application, are likely a stretch given current research.

This study which examined whether UV induced damage could be helped by topical Vitamin E treatment concluded that it could not.  And this study looked at the effect of topically applied vitamin E on scar tissue resulted in no observable benefit.  But other researchers have reported effects so a benefit is possible if not yet proven.  There is no evidence that using Vitamin E in hair will have any significant beneficial effect.

[Are vitamins effective in cosmetics? from Chemists Corner]

Almonds are a good source of vitamin E, but almonds are mostly lipids (fat) and protein.  Almond oil is a popular stand-alone moisturizer - something Ultratech highlights.  Ultatech also states almond is an antispasmodic.  Chemicals with antispasmodic properties can help  relieve spasms of involuntary muscle, under the general class of muscle relaxants.  Antispasmodic drugs are used most often in the treatment of cramps or spasms of the stomach, intestines, or bladder.

We have the opium poppy to thank for most modern antispasmodic drugs.  In the early 20th century, it was discovered that two different groups of opium alkaloids (pyridine-phenanthrenes and benzyl-isoquinolins) had antispasmodic properties.  This discovery prompted research into structurally related chemicals - one being benzaldehyde, which was found to behave as an antispasmodic when applied directly to different types of isolated muscle tissue.  Benzaldehyde is the main constitute of bitter almond oil, contributing to the smell and taste of this oil.   Though benzaldehyde acts as an antispasmodic, it is not used in that capacity6.  This is likely because benzaldehyde is easily oxidized to form benzoic acid, a chemical which does not act as an antispasmodic.  When we ingest benzaldehyde, one of the ways our bodies get rid of it is via oxidation to benzoic acid.  Upon application to skin, this oxidation of benzaldehyde also occurs.

Bitter almond oil is obtained by processing bitter almonds, a fruit of a variety of the almond tree (Prunus amygdalus).  The biggest commercial use of benzaldehyde is as a flavoring agent in foods, while in cosmetics benzaldehyde is used for fragrance and/or taste.  Sweet almonds, the fruit of a different variety of almond tree than bitter almonds, are also used in cosmetics.  However, the processing of  sweet almonds does not produce  benzaldehyde - this is a major distinction between bitter and sweet almonds.  Based on Ultratech's description for their almond ingredient, bitter almond oil might be the actual ingredient.  Even if bitter almond oil was used was used in 18 Again's formulation, it unlikely this would give 18 Again any antispasmodic action given our body's rapid metabolism of benzaldehyde.

Ultratech claims there are two antispasmodic ingredients - almond and Woodfordia fruticosa.  Regardless of the legitimacy of 18 Again's antispasmodic action claims, why would a type of muscle relaxant be added to a product marketed as a vaginal tightener?

 

Image 9: Ultratech's 18 Again

 

Centella asiatica, like Woodfordia fruticosa, has a long history of use in Ayurvedic system of traditional medicine.  Ultratech claims that the topical application of Centella asiatica (also known as gotu kola, pegaga or pennywort)  "...increases the tensile strength of flesh and tissues."   The basis of claim is likely a very specific Centella asiatica extract called TECA7 (titrated extract of Centella asiatica).

TECA is a highly purified extract, fractioned and enriched in triterpenic acid and triterpenic sugar ester fractions to reach about the 40% of asiaticoside and about the 60% of the triterpenic genins: asiatic acid and madecassic acid. The purification steps are extreme and involve chemical treatments that remove the herbal matrix. The final extract is a recombination of a highly refined extract with an isolated constituent and the natural proportion of the components is not maintained.

[Assessment report on Centella asiatica (L.) Urban, herba from the European Medicines Agency of the European Union]

TECA contains all of Centella asiatica's biologically active chemicals - asiaticoside, madecassoside, asiatic acid, and madecassic acid.  Cosmetics and products marketed for medicinal use which list Centella asiatica as an ingredient often actually contain TECA or asiatiocoside alone.  Animal research to date indicates that the topical application of a 1-2% preparation of TECA, or asiaticoside alone, may assist in wound healing chiefly by helping scar formation8.

Image 10: Collagen from human anterior cruciate ligament

Scaring is often thought of negatively, though it is a necessary part of wound repair.  The separation of tissue (wound) provokes a sequence of events and a host of processes to re-establish tissue connectivity and blood flow.  The job of patching-up tissue is done by collagen, a fibrous protein who's "day job" is to provide structural support and flexibility to a variety of tissues.  Though we often talk of collagen in the singular, there are over two dozen types of collagen distributed throughout the body.  Collagen I and III are involved in scar development, though normal scars9 are predominately collagen I.

The patch-job done by collagen (a 'scar') can takes weeks to complete.  TECA, or some of its active chemicals, appear to accelerate scar maturation by promoting the accumulation of collagen I10.  Promotion of collagen I accumulation may not mean TECA (or its active chemicals alone) spurs collagen I production.  In aid of collagen I accumulation, TECA (or its active chemicals alone) may work by limiting the body's method of breaking down collagen I.  More research is required to fully illuminate the role of Centella asiatica's biologically active chemicals in collagen accumulation.

Both collagen I and III are found in the vaginal sub-mucosa (lamina propria), as well as the muscularis.  While it may be tempting to conjecture that Centella asiatica's biologically active chemicals would boost vaginal collagen and somehow tighten the vagina, there is no published research demonstrating such effects11.  One may wish to speculate that application of a TECA-containing ointment would "protect" vaginal collagen - there is no published research demonstrating this effect either11.  Also, a healthy body does a very good job of maintaining its own collagen12.

A healthy body also does a very good job of keeping the vagina in top working order.  Indeed, a healthy body does all that Ultratech claims aloe vera gel will do.  Ultratech claims aloe vera "helps in cleaning the dead tissues on the skin and helps in the growth of new tissues... prevents fungal infections and is a very effective clotting agent... is used as lubricant and natural moisturizer... has healing properties and is used in treatment of vaginal infections, allergic reactions, preventing urinary tract infections, scarring and warts.... is very helpful in stimulating the immune system."

Though aloe vera is perhaps best known as a sunburn treatment, aloe vera has historically been used to treat everything from asthma to ulcers - and nearly everything in between.  A panacea aloe vera is not.

  • Aloe latex contains strong laxative compounds. Products made with various components of aloe (aloin, aloe-emodin, and barbaloin) were at one time regulated by the FDA as oral over-the-counter (OTC) laxatives. In 2002, the FDA required that all OTC aloe laxative products be removed from the U.S. market or reformulated because the companies that manufactured them did not provide the necessary safety data.
  • Early studies show that topical aloe gel may help heal burns and abrasions. One study, however, showed that aloe gel inhibits healing of deep surgical wounds. Aloe gel has not been shown to prevent burns from radiation therapy.
  • There is not enough scientific evidence to support aloe vera for any of its other uses.

[Aloe Vera from the National Center for Complementary and Alternative Medicine at the National Institute of Health; emphasis added]

Like aloe vera and other listed ingredients for 18 Again, gold has a long history in traditional and modern medicine13.  Gold is fairly nonreactive, which is one of the reasons gold is used to make things that we want to last - like jewelry and currency.  Under the right conditions, certain nonmetals can entice gold to participate in a reduction-oxidation ('redox') reaction.  Metallic gold has an oxidation number of 0, i.e. its number of electrons is equal to its number of protons.  During those redox reactions, gold will lose electrons to a nonmetal.  Typically, a redox reaction occurs to yield gold with an oxidation number of I (loss of 1 electron) or III (loss of 3 electrons).  Gold (III)  compounds are usually highly toxic, but some gold (I) compounds have been used to treat rheumatoid arthritis for over 75 years.

It is unlikely any gold (III) compounds are used given their toxicity.  It also seems reasonable to exclude the gold (I) compounds used to treat rheumatoid arthritis, if only because 18 Again is a cosmetic5 formulation rather than a drug formulation.  It is possible that 18 Again contains an Ayurvedic preparation called Swarna bhasma14, which contains nano-sized pieces of metallic gold.  Though Swarna bhasma contains metallic gold, this does not mean Swarna bhasma is nonreactive.  Nano-sized gold particles can be taken-up by cells and those gold redox reactions mentioned earlier do occur in our bodies.  Much more research is needed to fully characterize the action of gold nano-sized particles ('nanoparticles').  Though Swarna bhasma has been used for hundreds - perhaps thousands - of years, research into the biological activity of  gold nanoparticles is in its infancy.

For other 18 Again ingredients, the claims made for them implied what form of the ingredient was actually used.  Ultratech's claims for gold are so vague as to preclude any reasonable conclusion as to what exact form of gold was used.  The guess of Swarna bhasma is based solely on Ultratech's use of other herbal medicine staples like Woodfordia fruticosa and Centella asiatica.  However, based on currently available research on metallic gold, gold (I) and gold (III) compounds, it seems unlikely that gold would affect vaginal tightness.

 

Image 11: gold bars at the National Institute of Standards and Technology

 

The preceding review of anatomy and physiology, along with 18 Again's ingredients, support the position that this product will not tighten the vagina.

As 18 Again will not lead to vaginal tightening, what about the currently available 'vaginal rejuvenation' surgical procedures?  The American Congress of Obstetricians and Gynecologists' (ACOG) Committee on Gynecologic Practice addressed such options in the 2007 report Vaginal "Rejuvenation" and Cosmetic Vaginal Procedures.

There have been an increasing number of practitioners offering various types of vaginal surgeries marketed as ways to enhance appearance or sexual gratification. Among the types of procedures being promoted are so-called "vaginal rejuvenation," "designer vaginoplasty," "revirgination," and "G-spot amplification."  Often the exact procedure performed is not clear because standard medical nomenclature is not used.  Some procedures, such as vaginal rejuvenation, appear to be modifications of traditional vaginal surgical procedures.  Other procedures are performed to alter the size or shape of the labia majora or labia minora.  Revirgination involves hymenal repair in an attempt to approximate the virginal state. G-spot amplification involves the injection of collagen into the anterior wall of the vagina.

Medically indicated surgical procedures may include reversal or repair of female genital cutting and treatment for labial hypertrophy or asymmetrical labial growth secondary to congenital conditions, chronic irritation, or excessive androgenic hormones.  Other procedures, including vaginal rejuvenation, designer vaginoplasty, revirgination, and G-spot amplification, are not medically indicated, and the safety and effectiveness of these procedures have not been documented. No adequate studies have been published assessing the long-term satisfaction, safety, and complication rates for these procedures.

Also of concern are ethical issues associated with the marketing of these procedures and the national franchising in this field. Such a business model that controls the dissemination of scientific knowledge is troubling.

Clinicians who receive requests from patients for such procedures should discuss with the patient the reason for her request and perform an evaluation for any physical signs or symptoms that may indicate the need for surgical intervention. A patient's concern regarding the appearance of her genitalia may be alleviated by a frank discussion of the wide range of normal genitalia and reassurance that the appearance of the external genitalia varies significantly from woman to woman (1). Concerns regarding sexual gratification may be addressed by careful evaluation for any sexual dysfunction and an exploration of nonsurgical interventions, including counseling.

It is deceptive to give the impression that vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, or any such procedures are accepted and routine surgical practices. Absence of data supporting the safety and efficacy of these procedures makes their recommendation untenable. Patients who are anxious or insecure about their genital appearance or sexual function may be further traumatized by undergoing an unproven surgical procedure with obvious risks. Women should be informed about the lack of data supporting the efficacy of these procedures and their potential complications, including infection, altered sensation, dyspareunia, adhesions, and scarring.

[emphasis added]

 

Ultratech's 18 Again is at best a fairly benign cosmetic.  At worst, 18 Again is another product banking on potential customer's poor body image and scientific ignorance.

____________________________

I am a PhD chemist, not a MD specializing in gynecology.  This post in no way serves as medical advice.  

Ladies, see a reputable gynecologist with medical questions.  Gentlemen, you can too if you've got questions!

____________________________

Footnotes

1Statements made in this post that fall in the general category of chemical safety are based on the assumption of standard US cosmetic formulation (footnote #5) concentrations and no special individual sensitivity to a specific chemical.  Ultratech does not provide the complete list of ingredients for 18 Again on its website.  From the ingredient list provided, it is not clear the exact form certain ingredients are in.  As such, I have speculated as to each ingredient’s actual form when possible. Ultratech also does not indicate the concentration of any chemicals in their formulation.  As such, I am assuming 18 Again's ingredients are present at concentrations typical for cosmetic formulations available for purchase in the United States.

2At this point, this post is over 1,700 words.  This would be a good time for a coffee & cookie break.

3This advice likely applies to the use of highly astringent mouthwashes, douches, and even the use of "harsh" astringents on skin rather than the causal consumption of foods containing certain polyphenols with astringent properties (e.g. coffee, wine, etc.).

4Let me reiterate that I am assuming a alum concentration that would be acceptable for a cosmetic in the US.  Regardless, vaginal douching with alum can have serious consequences.

5I consider 18 Again as a cosmetic based on the FDA publication Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).  Though some media outlets have quoted Ultratech representatives as stating 18 Again is "FDA approved", this product is not FDA approved.  The FDA does not "approve" cosmetics and there is no record of the FDA classifying 18 Again as a drug.  As an aside, one could certainly argue that as Ultatech is essentially claiming that 18 Again will "affect the structure or function of the body", the FDA should issue a warning letter to Ultratech.

6Benzaldehyde is used to make other chemicals that are used as antispasmodic agents.

7TECA is also known as TTF (total triterpenic fraction) and TTFCA (total triterpenic fraction of Centella asiatica) [source]

8Some papers also mention TECA or asiatiocoside alone may also help in the development of new blood vessels from existing ones (angiogenesis).  The majority of work, however, focuses on collagen production.

9In a non-normal scar (i.e. hypertrophic scar), the amount of collagen III is higher.  Hypertrophic scars often appear raised and thicker than normal scars. [Widgerow, A.; Chait, L.; Stals, R.; and Stals, P. (2000) New Innovations in Scar ManagementAesthetic Plast Surg, 24(3):227-34.]

10Selected references: Kimura, Y. et al. (2008) Facilitating action of asiaticoside at low doses on burn wound repair and its mechanism. Eur J Pharmacol., 584(2-3):415-23 | Widgerow, A.; Chait, L.; Stals, R.; and Stals, P. (2000) New Innovations in Scar ManagementAesthetic Plast Surg, 24(3):227-34 | Lee, et al. (2006) Asiaticoside induces human collagen I synthesis through TGFbeta receptor I kinase (TbetaRI kinase)-independent Smad signaling. Planta Med., 72(4):324-8 | Coldren, C., et al. (2003) Gene expression changes in the human fibroblast induced by Centella asiatica triterpenoids. Planta Med., 69(8):725-32 | European Union. European Medicines Agency. Committee on Herbal Medicinal Products. Assessment report on Centella asiatica (L.) Urban, herba. London: European Medicines Agency, 2010.

11No such research was found using scholastic search services (e.g. PubMed, SciFinder, Google Scholar, etc.)

12Menopause appears to bring about changes in vaginal collagen.  Sridharan et al.  examined vaginal tissue changes to vaginal collagen pre-menopause (pre-M) and post-menopause (post-M), finding “…post-M samples showed micro-scale heterogeneity in elasticity and altered nanoscale arrangement.”  Vaginal tissue samples were from five women, two pre-M (ages 34 and 38) and 3 post-M (ages 58, 63 and 66).  [Sridharan, I. et al. (2012) Structural and mechanical profiles of native collagen fibers in vaginal wall connective tissues. Biomaterials., 33(5):1520-7]  It is beyond the scope of this post to examine the influence of menopause on vaginal elastic fibers or related hormone therapies.

13Information regarding the toxicity and medicinal use of gold was mainly gleaned from the following references: Berners-Price, S. and  Filipovska, A. (2011) Gold compounds as therapeutic agents for human diseases. Metallomics, 3(9): 863-873 | Kean, W. and Kean, I. (2008) Clinical pharmacology of gold. Inflammopharmacology, 16(3):112-25. | Johnson, H. et al. (2010) A review of the in vivo and in vitro toxicity of silver and gold particulates: particle attributes and biological mechanisms responsible for the observed toxicity. Crit Rev Toxicol., 40(4):328-46. | Witkiewicz, P. and Shaw, C. (1981) Oxidative cleavage of peptide and protein disulphide bonds by gold(III): a mechanism for gold toxicity. J. Chem. Soc., Chem. Commun., Issue 21: 1111-1114 | Messori, L., et al. (2000) Gold(III) Complexes as Potential Antitumor Agents: Solution Chemistry and Cytotoxic Properties of Some Selected Gold(III) Compounds. J. Med. Chem.43 (19): 3541–3548 | Best, S. and Sadler, P. (1996) Gold drugs: Mechanism of action and toxicity. Gold Bull., 29(3): 87-93 | Graham, J. and Fletcher, A. (1943) Gold Therapy in Rheumatoid Arthritis. Can Med Assoc J., 49(6): 483–487

14Swarna bhasma Composition information from the following references:  Brown, C., et al. (2007) Nanogold-pharmaceutics. (i) The use of colloidal gold to treat experimentally-induced arthritis in rat models;. (ii) Characterization of the gold in Swarna bhasma, a microparticulate used in traditional Indian medicine. Gold Bull., 40(3):245 | Shah, Z., et al. (2005) Attenuation of stress-elicited brain catecholamines, serotonin and plasma corticosterone levels by calcined gold preparations used in Indian system of medicine. Basic Clin Pharmacol Toxicol, 96(6):469-74

 

Image attributions

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Image 5 screen capture of 18 Again website, "Nature Ingredients" tab

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3 responses so far

  • OmegaMom says:

    I would think that doing kegels twice daily for three months would do exactly what they're purporting this cream does...which is why doing that is included in the instructions. And in the end, the woman using it can say, "Omigosh! Look, Jane! This cream--it does what it says!" But if they just forewent the cream and did the kegels alone, twice daily, religiously, boom, they'd have the same results.

    Thanks for the lengthy dissection of their claims!

  • DrR, I stand in awe. You've written an expert deconstruction of what is, "at best a fairly benign cosmetic. At worst, 18 Again is another product banking on potential customer's poor body image and scientific ignorance." Couldn't have said it better myself.

    At first, I was concerned that this was some sort of estrogen cream intended for vaginal application. Compounding pharmacies are making a ton off this and related products and Pfizer even released a prescription version of a cream containing their Premarin brand of conjugated estrogens. (Here's the prescribing info as a PDF so you can see the medical indications --
    Treatment of Atrophic Vaginitis and Kraurosis Vulvae
    Treatment of Moderate to Severe Dyspareunia, a Symptom of
    Vulvar and Vaginal Atrophy, due to Menopause

    -- and actual clinical trial data that it works to increase the percentage of superficial cells of the vaginal epithelium (but not tighten vaginal muscles, of course). However, I understand from pharmacists that a trend exists for non-menopausal users. Sadly, I even saw a TV interview of a Nevada prostitute who uses some kind of estrogen cream and reports that she has many return clients who enjoy the fullness of her vagina. I kid you not (but I can't find an online reference presently).

    Of course, even Pfizer lists on the prescribing information that unopposed estrogens carry with them an increased risk of endometrial cancer for women with a uterus (as well as, "breast cancer, cardiovascular disorders, breast cancer, and probable dementia.")

    And, indeed, OmegaMom makes a superb observation that doing/taking anything *and* doing kegels will strengthen the pelvic floor.

    Sorry to hijack the comment thread somewhat off-topic but I suspect that this post will draw readers who might be using vaginal estrogen creams.

  • PalMD says:

    Wonderful post. As you noted briefly, the whole idea of "revirgination" is offensive, and needs to be separated from how a woman feels about her vagina. If she is having urinary or sexual dysfunction, these can be treated, often with exercises, or medications, or surgery depending on the extend of the problem.

    It's not clear to me what they are trying to market and for whom. Is it for women whose male partners are unhappy? Is it for women who are being shamed into thinking their vaginas aren't OK? Or is it for women genuinely worried about their health as above?

    Putting anything on a mucosal surface should be done with caution. Lipophilic compounds can easily be absorbed systemically with unknown consequences (see news items for "beer enemas").

    As you point out, there's no reason to think any of these substances should do anything useful.

    For dyspareunia, or painful intercourse, a variety of options can be tried, depending on the cause. If the cause is rooted in a history of sexual abuse, then therapy can help. If it's dryness, lubricant can help. If it's changes to the mucosa related to menopause, estrogen creams can help.

    As I think about it, it IS clear to me what is being advertised, and that's re-virgination, aimed at men and at women who are being shamed for being old, or sexually active, or independent.

    Yuck.

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