These procedures aim to inject bio-compatible material (perianal injectable bulking agents, also termed sphincter bulking agents or biomaterial injectables) into the walls of the anal canal, in order to bulk out these tissues. This may bring the walls of the anal canal into tighter contact, raising the resting pressure, creating more of a barrier to the loss of stool, and thereby reducing fecal incontinence. This procedure has many advantages over more invasive surgery, since there are rarely any serious complications.
History Originally, injectable bulking agents were used to treat stress urinary incontinence in females. The procedure aimed to bulk out the tissues of the neck of the bladder, and it was successful. The technique was first used for FI in 1993 by an Egyptian surgeon. He used polytetrafluroethylene (PTFE/polytef/Teflon) paste injected into the submucosal layer of anal canal. Later publications described autologous transplantation of fat from the abdominal wall or the buttock. After about the year 2000, many different materials started to be used as well as variations of the technique. Some of these materials were concurrently being used to treat urinary incontinence. The latest development of this technique is the implantable bulking agents "Gatekeeper" and "Sphinkeeper". These are not injectable materials but rather implants which expand after placement. As such, they are termed "self-expandable prostheses", and the term "non-self-expandable prostheses" is used to refer to older injectable materials.
Procedure The exact methods of this procedure are not standardized and vary considerably, for example the exact number and locations of the injections and the volume of the injected material.
Before the operation, antibiotic prophylaxis may be given. The rectum is prepared with a phosphate enema at least 2 hours before the procedure. The procedure can be carried out under local anesthetic on an out patient basis, or with caudal epidural anesthesia, or with intravenous sedation, or under general anesthesia. Ultrasound guidance may be used during the injections, which is sometimes reported as being more effective than the surgeon simply palpating (feeling) and looking where to inject.
The site of the bulking material can be inter-sphincteric (in the space between the IAS and the EAS), submucosal injections (under the mucosal layer, usually just above the dentate line), or within the IAS itself. Injection of the material can be by the different routes: transanal route, trans-sphincteric, intersphincteric, perianal route (going through the muscle complex) or transcutaneous route. As such, there are several different variations of injection location and route: Trans-sphincteric route into the IAS, Inter-sphincteric route into the IAS, Inter-sphincteric route into the submucosa, Trans-anal injection into the submucosa (similar to injection sclerotherapy for haemorrhoids), Trans-sphincteric route into the inter-sphincteric space, Inter-sphincteric route into the inter-sphincteric space, Trans-sphincteric route injecting submucosally.
The perianal injection route (intersphincteric or transsphincteric) gives better results than the transanal route according to one review. Submucosal implant location may have a higher risk of erosion and sepsis.
Injectable materials Many different materials have been used as perianal injectable bulking agents. The ideal injectable or implantable material would be biocompatible, non-migratory, non-allergenic, non-carcinogenic and non-immunogenic (and therefore induce a minimal inflammatory and fibrotic reaction). The material should also be easy to inject. The particles should be greater than 80 μm in diameter in order to prevent migration away from the injection site. On the other hand, materials with particles small enough to be used in small caliber needles may be desirable, in order to leave a smaller needle track, which may reduce the chance of leakage of the material via the needle track. Alternatively, some materials are shape-retaining porous hydrogels with no particles. The ideal material should produce an improvement in continence not only in the short term, but in the long term, and repeated procedures should not be necessary. Technically, most materials are particles suspended in a carrier (excipient) solution, which is usually a biodegradable gel. It is not known which of the available materials is the best.
Autologous fat (fat tissue transferred from elsewhere in the body). Teflon. Bovine glutaraldehyde cross-linked collagen (collagen from cows). Carbon-coated zirconium/graphite beads ("Durasphere"). Polydimethylsiloxane elastomer (silicone) biomaterial implants ("PTQ implant"). Dextranomer in non-animal stabilised hyaluronic acid ("Solesta", "NASHA Dx"). Hydrogel cross-linked with polyacrylamide ("Bulkamid"). Porcine dermal collagen (collagen from pig skin, "Permacol"). Synthetic calcium hydroxylapatite ceramic microspheres. Polyacrylonitrile in cylinder form. aluminum potassium sulfate and tannic acid (ALTA).
Teflon (polytef) This was the original material used as a bulking agent, first used to treat urinary incontinence in 1964, and then about 20 years later it was the first material used as a bulking agent to treat FI. Polytef paste is polytetrafluoroethylene, glycerin and polysorbide. The particles are mostly very small in size (4–40-μm). Research in animals has shown that these particles migrate and may be found in lymph nodes, lungs, kidneys, spleen and brain. If the material mostly migrates away, any benefit will be temporary, and there are safety concerns that it could lead to the formation of foreign body granulomas and the development of sarcoma.
Autologous fat transplant This variation of the procedure uses the patient's own fat cells, and therefore is non-allergenic and non-immunogenic. The fat cells are taken from the abdominal wall by suction. Then they are purified and put into a saline solution before injection. When used in other fields such as urology or facial surgery, autologous fat transplants have very rarely been reported to cause fat embolism and stroke. This material is also subject to rapid digestion and migration.
PTQ implant This is a silicone biomaterial, marketed as "PTQ" or "Bioplastique". It is polydimethylsiloxane elastomer particles suspended in a biocompatible carrier hydrogel of poly-N-vinyl-pyrrolidone (povidone). Significantly more publications exist which investigate this material compared to the other materials, and it has been the most widely used bulking material used for FI. Publications used inter-sphincteric or within IAS injection sites via the trans-sphincteric route. The particles are in the range 100–450 μm with smaller particles in the gel. Therefore there is a possibility of migration and granuloma formation. There are also concerns about a link between autoimmune diseases and silicone. The bulking agent is very viscous which makes it difficult to inject. After injection there is irregular collagen deposition around and inside the implant.
Durasphere After PTQ, this material has most scientific publications. Publications described using it via the transmucosal or trans-sphincteric routes, with the end location of the material being the submucosa. It is composed of carbon-coated zirconium beads (pyrolytic carbon-coated beads) in a water-based carrier gel containing β-glucan. Pyrolytic carbon is not biologically reactive and does not undergo degradation. It is used in various medical devices including heart valves. The particle size of Durasphere is in the range 212-500 μm, which is approximately 3 times the migration threshold of 80 μm. However, one report of the material as used in urology showed significant migration to local and distant lymph nodes.
Dextranomer in sodium hyaluronate This is a newer material which became more popular after 2011. It is marketed as NASHA Dx, Zuidex, or Solesta. As of 2022, NASHA Dx is the only material approved in the US by the U.S. Food and Drug Administration (FDA). This material is composed of crosslinked dextranomer (dextran) microspheres and non-animal stabilized sodium hyaluronate (NASHA) in phosphate-buffered 0.9% sodium chloride solution. The particles are 120 μm in diameter. The material is non-allergenic, non-immunogenic and non-migratory. After injection, the hyaluronic acid is degraded, and soft tissue fibrosis forms with ingrowth of fibroblasts, inflammatory cells, blood vessels and collagen. This means that even though the particles undergo degradation, the bulking effects may persist. There are several publications which report the use of this material. They used submucosal injection site via the transmucosal route. Uncertainty about indications, cost, and durability of the material in the long term stopped widespread adoption of this material.
Calcium hydroxylapatite Marketed as "Coaptite", this is spherical particles of calcium hydroxylapatite ceramic suspended in a sodium carboxylmethylcellulose, glycerine and water carrier gel. This is a synthetic version of a compound that is a normal component of bones and teeth. It is non-antigenic and noninflammatory. The particle size is in the range 75–125 μm and therefore should avoid migration away from the implant site. Once in place, the particles are enmeshed in a non-encapsulated stable soft collagen matrix. This matrix maintains volume even after the solid particles have been degraded and resorbed. The material is radio-opaque (and therefore will be visible on x-rays). It has been used in dental and orthopedic reconstructive surgery, and for replacement heart valves. In the field of plastic surgery, it is termed Radiance FNTM. As of 2022 only one publication exists. The material was used in submucosal injection site via transsphincteric route.
GAX (glutaraldehyde cross-linked) collagen GAX (glutaraldehyde cross-linked) collagen is purified collagen from cow skin, marketed as Contigen. Enzymes are used to remove telopeptides, which reduces the antigenicity (the degree to which the body's immune cells will be able to recognize the material as a foreign body). About 5% of patients will have an immune reaction to this material, therefore allergy testing is carried out before the final procedure. There is also a concern about disease transmission. This material contains 95% collagen Type I and 1-5% of collagen Type III. Chemical cross-linking with glutaraldehyde is intended to stop the degradation of the material by collagenases. The carrier solution is physiological saline with phosphate. The material does not seem to be associated with formation of granulomas or migration, however it is subject to degradation over time. In publications it has been used with submucosal injection site via transmucosal route. This material has not achieved widespread use.
Porcine dermal collagen Cross-linked porcine dermal collagen matrix (collagen from pig skin) has been used, marketed as Permacol. It consists of large particles of cross-linked porcine dermal collagen. It has been used for urinary incontinence and for facial contour augmentation, as well as for FI. It is biocompatible, non-allergenic and has improved durability due to revascularization and cell ingrowth following injection. In several publications where the material was used for FI, submucosal or intersphincteric injection site was used, via the transmucosal or intersphincteric routes.
Hydrogel cross-linked with polyacrylamide