Introduction
Advancements in medical technology have significantly improved the quality of life for individuals experiencing erectile dysfunction (ED). Penile implants have evolved as a viable solution for those who do not respond adequately to oral medications or injections. This article focuses on the latest innovations in penile implants.
The Evolution of Malleable Implants
Traditionally, penile implants were known to cause a reduction in the size of the erected penis. However, recent developments in design and materials have addressed these issues making it possible to simultaneously perform the shaft augmentation as well. Not only will there be no decrease in penis size, there actually will be an increase to a desired larger size.
Advantages Over Other Implants
Inflatable implants, though effective, come with a higher risk of complications due to their complex structure involving more "moving parts." These can include mechanical failures and infections. They also require manual manipulation of a pump to inflate or deflate, which can be cumbersome for some users.
In contrast, malleable implants offer a simpler, more user-friendly solution. With no need for a pump or reservoir, these implants are always ready for sexual activity. The ease of positioning the penis for intercourse is a significant advancement, offering spontaneity and reducing the preparatory steps needed for sexual encounters.
Sexual Function and Satisfaction
One of the critical concerns with penile implants is the impact on sexual function, including sensation, orgasm, and ejaculation. This malleable implant maintain normal sexual function, allowing the user to experience orgasm and ejaculation. This aspect is crucial for users who wish to maintain a natural sexual experience. Additionally, the ability to have sex anytime and for as long as desired without mechanical or procedural hindrances is a considerable benefit. This feature not only enhances sexual freedom but also contributes to overall satisfaction and quality of life.
Indications and User Preference
The malleable implants are particularly indicated for individuals with erectile dysfunction who have not found relief with oral medications or injections like trimix or bi-mix. Even among those who respond to these treatments, many prefer the convenience and reliability of an implant. The assurance of being able to engage in sexual activity without the need for preparatory injections or medications is a significant advantage that cannot be understated.
Conclusion
The advancements in malleable penile implants mark a significant step forward in the treatment of erectile dysfunction. These implants address previous limitations regarding aesthetics, functionality, and ease of use, offering a more satisfying and spontaneous sexual experience. As technology continues to evolve, it is expected that these implants will become even more efficient. Added to this, a simultaneous augmentation of the penis shaft further improves the quality of life for individuals with ED.
For More information, you can contact Dr. Victor Liu's Office at 650-697-8888, or by email at VictorLiuMD@Yahoo.com.
Product information gathered by
Luis C. Casavantes, MD., and Palmira Morales, MD.
November 2023.
Ellansé™, launched in 2009, is a brand of dermal filler used for different clinical indications like aging face (facial rejuvenation) and volume restoration of diverse body areas, including the penis (nonsurgical phalloplasty).
Ellansé™ is manufactured by AQTIS Medical BV (Sinclair Pharma) in the Netherlands.
Ellansé™ is a long-term injectable implant with breakthrough technology made of polycaprolactone (PCL) microspheres, a synthetic polymer suspended in a gel of carboxymethylcellulose (CMC), glycerin, and buffered saline solution.
The content of PCL/CMC in Ellansé™ is 30/70%.
Ellansé™ is a sterile, single-use, latex-free, non-pyrogenic, bioresorbable, non-permanent injectable implant; it is a stand-alone device that should not be combined with any other device to meet its intended purpose.
The product is easy to inject using a 27G needle or micro-cannula.
Ellansé™ is available as a box containing two individually packed, pre-filled, ready-to-use, 1 ml. syringes and four individually sealed sterile 27G needles.
The two main indications of Ellansé™ are:
1. Correction of signs of aging, such as wrinkles, fine lines, and loss of facial volume in areas such as cheeks, temples, and jawline.
2. Penile volume augmentation
Ellansé™ is known for its unique properties, distinguishing it from most other dermal fillers; its main characteristics include:
1. Stimulation of new collagen in the area of injection. This collagen stimulation helps to improve skin elasticity and firmness, contributing to a more youthful appearance.
2. Long-lasting results: One of the notable features of Ellansé™ is its duration of effect. While many dermal fillers provide either permanent or temporary results, Ellansé™ can last longer, typically more than four years, due to the collagen-building effects and the low rate of absorption of PCL.
3. Gradual and natural results: Ellansé™'s effects develop gradually, creating a more natural-looking outcome than other fillers. This progressive enhancement allows patients to achieve and maintain their desired results over time.
4. Different formulations: There are two varieties of Ellansé™, classified according to their longevity: Ellansé™ S, whose effect lasts for 18+ months, and Ellansé™ L, which lasts for 24+ months; its longevity depends on the chain length of PCL. The choice of formulation depends on the individual patient's needs and the desired treatment area. The vast majority of phalloplasty patients opt for Ellansé™ M.
The PCL filler induces the formation of collagen type-III and type-I at an early stage (measured at nine months) and later predominantly collagen type-I, which deposits around the PCL microspheres (measured at 21 months). Human biopsies have demonstrated that PCL also stimulates the formation of new elastin fibers and capillaries.
The body naturally hydrolyses PCL into carbon monoxide and water, leaving residual collagen type-I and type-III, which extends the life of the additional volume beyond the life of the PCL microspheres.
The turnover rate of collagen can vary with age, genetics, and overall health. In general, collagen turnover rates tend to slow down as people age. Younger individuals may have a faster collagen turnover rate, contributing to skin's elasticity and youthful appearance.
As published by Kim, PCL particle size was mathematically calculated for four years in an in vivo biopsy study. Until three years after the injection, PCL particles remained smooth, and their diameter persisted at 95.47%, showing phase-I isovolemic degradation. Four years after the injection, particles decreased in size and became very rough, showing phase-II bulk degradation. The author concluded that Ellansé™-M's longevity was longer than four years.
There isn't a specific "time cycle" for the turnover of collagen that applies universally, as it varies between tissues and individuals.
Factors that influence collagen turnover include:
1. Age: Collagen turnover tends to decrease with age, leading to reduced production and increased degradation.
2. Genetics: Genetics can affect how collagen is synthesized and replaced in the body.
3. Environmental factors: Sun exposure, smoking, and other environmental factors can accelerate collagen breakdown and affect the turnover rate.
4. Health and diet: Your overall health and diet can impact collagen production and turnover. A balanced diet rich in essential nutrients can support collagen production.
5. Lifestyle factors: Exercise and physical activity can also influence collagen turnover, stimulating collagen production.
In vitro trials have demonstrated that the presence of ascorbate (Vitamine C) enhances the production of collagen by the native fibroblasts.
A review of adverse effects of Ellansé™ as a facial filler from 2009 to 2022 showed that the event rate was 0.0462% (or one event in every 2,165 syringes used). They include nodules, hardness, infection, swelling, and bruising [1].
There are no documented side effects for patients who underwent nonsurgical phalloplasty with Ellansé™ because, to this date, this indication continues to be off-label. Further clinical trials are necessary to establish its safety and efficacy.
Bibliography
Christen MO, Vercesi F. Polycaprolactone: how a well-known and futuristic polymer has become an innovative collagen-stimulator in aesthetics. Clin Cosmet and Investig Dermatol 2020; 13:31-48.
Oh H, Lee S, Na J. Comparative evaluation of physical characteristics and preclinical data of a novel monodisperse polycaprolactone microspheres filler. Aest Plas Surg 2022; 46:225-226.
Kim J. Isovolemic degradation of polycaprolactone particles and calculation of their original size from human biopsy. Plast Reconstr Surg Glob Open 2020; 8(6):e2866.
Middelkoop E, de Vries H, Ruufs L, et al. Adherence, proliferation and collagen turnover by human fibroblasts seeded into different types of collagen sponges. Cell and Tissue Research 1995; 280;447-453.
Zhao H, Ren R, Bao S, et al. Efficacy and safety of polycaprolactone in treating nasolabial folds: A prospective, multicenter, and randomized controlled trial. Facial Plas Surg 2023; 39(3):300-306.
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The first attempts at procedures to increase penis volume were surgical, using materials and techniques that soon became obsolete due to their aggressiveness, high incidence of serious adverse effects, and permanent complications.
There was a dramatic change in the phalloplasty scene when Luis Casavantes (Avanti Derma, 2007) popularized two injectable soft tissue fillers with nonsurgical techniques that quickly became popular; these two products offered entirely different results, one firm and permanent (PMMA) and the other soft, sometimes spongy and short-lasting (hyaluronic acid). At that time, there was no intermediate option.
Later, a third player (long-lasting polycaprolactone, or PCL) entered the scene around 2013 under the trademark of Ellansé™, offering advantages that positioned it at an intermediate point between the two existing products.
Although clinical studies still need to be carried out to bring more support to the use of PCL for nonsurgical phalloplasty, we have seen that it has the following advantages over its older competitors:
• The PCL implant lasts much longer than the hyaluronic acid implant. The microspheres of PCL enter phase II of degradation until the forth year after injection.
• The PCL implant is absorbed exceptionally slowly, and unlike PMMA, which persists for life, the former eventually disappears, allowing the tissues to return to their basal conditions; the advantage is that the patient is freed from the implant in the later stages of his life when his priorities change.
• The hyaluronic acid gel retains water and it can be soft and spongy, mainly when used in high volume. We have reports of patients who left finger marks after handling the penis firmly.
• PCL and PMMA implants owe their volume to new collagen formation, so their consistency is natural and much firmer than hyaluronic acid.
In our practice, we have found that the effect of Ellansé™ on the penis lasts much longer than the 18-24 months that researchers have reported in patients who received it on the face. At Avanti Derma, we have Ellansé™ non-surgical phalloplasty patients who have had the implant for almost a decade, and its absorption has not been sufficient to justify a touch-up or an additional session.
So, the big question now is: could Ellansé™ be the most advanced product for nonsurgical phalloplasty that we have now?
Those readers interested in more knowledge of Ellansé™ will find intermediate/high-level technical information in the following attachment. Ellansé™ Monography
If you have any further questions or comments, please do not hesitate to contact Dr. Luis Casavantes (info@avantiderma.com).
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