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Tracheo-esophageal voice prosthesis use & care

Restoring speech communication using a voice prosthesis was a significant medical advancement for laryngectomees. It enables the laryngectomee to create sound again immediately after its insertion. A voice prosthesis is inserted through a previously fistula created by a tracheoesophageal puncture (TEP) connecting the trachea and esophagus in those wishing to speak through tracheo-esophageal speech. It enables the individual to exhale pulmonary air from the trachea into the esophagus through a silicone prosthesis that connects the two; the vibrations are generated by the lower pharynx.

Advantages of using tracheo-esophageal speech:

  • The use of pulmonary air supply for speech
  • Natural sounding phonation
  • Voice restoration usually occur within 2 weeks of surgery (primary TEP)
  • The voice prosthesis may be maintained by patient, increasing independence

Disadvantages:

  • Additional surgery is required for secondary puncture
  • Daily maintenance of voice prosthesis
  • Aspiration may occur if fluids leak through a malfunctioning valve or arround the voice prosthesis
  • Dependency on speech and language pathologist
  • Cost




Types of voice prosthesis

Voice-prostheses types vary in size, shape, resistance levels, material, insertion techniques and valve life. There are two types of voice prosthesis: an indwelling one that is installed and changed by a speech and language pathologist (SLP) or otolaryngologist and a patient-changed one. 

Characteristics of the non-indwelling and indwelling voice prosthesis:

Non-indwelling

  • Maintained by patient
  • Less expensive
  • Tab remains in place
  • More frequent replacement 

Indwelling

  • Managed by health professional
  • More expensive
  • Tab is optional
  • Longer duration in-place


Indication for voice prosthesis replacement are:

  • Leakage through or around the prosthesis
  • Poor trachea - esophageal voice
  • Ill fitted voice prosthesis – either too long or too short
  • Accidental dislodgement


The process of replacing an indwelling voice-prosthesis starts with removal of the old prosthesis; followed by dilation, seizing, and repeated dilation of the puncture; and finally inserting the new prosthesis. The indwelling prosthesis generally lasts a longer time than the patient managed device. However, prosthesis eventually leak mostly because yeast and other microorganisms grow into the silicone leading to incomplete closure of the valve flap.  When the valve flap does not close tight anymore, esophageal fluids can pass through the voice prosthesis (see below in Causes of voice prosthesis leak section). Prosthetic options to address leakage through the prosthesis may use biofilm resistant materials, designs that inset the flap into the shaft of the prosthesis to minimize contact with esophageal contents, double valves, and/or magnets. 

The newly inserted prosthesis is assessed for length, fitness to the mucosal wall, absence of leakage, and adequate voicing quality, fluency and speaking effort.

It is recommended to test for leakage at least once a week. Testing can be done by standing in front of a mirror using a flashlight or light directed at the stoma, taking a drink ( preferably of colored beverage), and look at the prosthesis while drinking. Coughing is generally induced when leakage occurs.


An indwelling prosthesis can function well for weeks to months. However, some SLPs believe that it should be changed even when it does not leak after six months because, if left for a longer time, it can lead to dilatation of the puncture leading to leakage.  ( See picture below)


 
Vega voice prosthesis after 6 months showing deposits of biofilm that can cause dilation of the puncture fistula)


The patient managed voice prosthesis allows greater degree of independence. It can be changed by the laryngectomee on a regular basis (every 1-2 weeks). Some individuals change the prosthesis only after it starts leaking. The old prosthesis can be cleaned and reused several times. 

A number of factors determine an individual's ability to use a patient managed voice prosthesis:

  • The location of the puncture should be easily accessible; however,  the site of the puncture may, migrate over time, making it less accessible.
  • The laryngectomee should have adequate eyesight and good dexterity, enabling him/her to perform the procedure, and capable of following all the steps involved. An indwelling voice prosthesis does not need to be changed as frequently as a patient managed one.

Two videos made by Steve Staton explain how to replace a patient-changed prosthesis:  Prosthesis installation 1 and prosthesis installation 2.

The main difference between the clinician-changed and patient-changed voice prosthesis is the size of the flanges. The larger size flanges on the clinician-changed devices make it harder to accidentally dislodge it. Another difference is that the insertion strap should not be removed from the patient-changeable prosthesis because its helps to anchor the prosthesis. There is generally no difference in voice quality between a clinician-changed and a patient-changed device.

           

                          

                                            A voice prosthesis (Vega TM Atos Medical)





Potential reasons for not getting voice prosthesis

Not every laryngectomee is able to use voice prosthesis. Reasons for not having a voice prosthesis (contra indications)  include:

  • Poor dexterity
  • Poor eye sight
  • Poor pulmonary function
  • Impaired mental status
  • Lack of motivation
  • Inability to manage associated care of stoma and voice prosthesis
  • Voicing difficulties
  • Glosectomy with associated poor articulation
  • History of radiation therapy with fibrosis, thereby decreasing the ability of tissue to vibrate
  • Esophageal stenosis with stricture
  • Extensive surgical resection / reconstruction with involvement of the tongue
  • Recurrent aspiration and dislodging of the voice prosthesis
  • Difficulty in occluding the stoma
  • Proximity of speech pathologist or otolaryngologist
  • Lack of support system
  • Potential cost and lack of reimbursement


Individuals who are receiving antiplatelet agents should consult the clinician who manages the patient's long-term anticoagulation (e.g., cardiologist, neurologist) to estimate the laryngectomee’s thrombotic risk and to determine if antiplatelet therapy can be safely interrupted prior to created TEP or changing the voice prosthersis (see Preventive Care secion).

The American Speech - Language - Hearing Association ( ASHA) published guidelines about use of voice prosthesis and HME and their care.






What to do if the prosthesis is dislodged?

If the prosthesis leaks or has become dislodged or has been removed accidentally, a patient-changed prosthesis (specific to the type and width of the prosthesis) can be inserted by those who carry an extra device. Alternatively, a 12 Fr/ 16’’red rubber catheter can be inserted into the tracheo-esophageal puncture, which can close within a few hours, to prevent its closure.  The catheter should be pushed a few inches down into the esophagus and the far end of it should be securely taped to the chest wall.  Inserting a catheter or a new prosthesis can prevent the need for a new tracheo-esophageal puncture.




Watch a video that explains how to insert a catheter:




Red rubber catheter





Voice prosthesis plugs

Using a plug allows continued eating and drinking while waiting for voice prosthesis replacement due to leaking through. It can be inserted with the non-bristled end of Provox Brush. (see Picture below) Speaking is not possible with a Plug in place.



The end of the Provox brush allows insertion of the plug (left), and the distal end of the plug is left outside the baseplate. (Courtesy of William Cross)


Dislodging of the voice prosthesis usually occurs when patients attempt to clean or replace the device and a cough is stimulated.  Sudden inspiratory effort increases the risk of aspirating the device when it is not secure at the trachea. When the voice prosthesis is dislodged, one of three possibilities may occur:

1.       The patient may cough it out.
2.       It may fall into the esophageal side of the fistula tract and get swallowed where it will eventually pass through the digestive tract.
3.       It may fall into the trachea and become aspirated. This will immediately generate intense coughing that may expel the prosthesis though the stoma.  If this occurs the patient must seek medical attention immediately, as this can be life-threatening. It is important to have the inhaled prosthesis removed from the lungs.


The most common location for device impaction is at the level of the upper right main stem bronchus and carina. This usually is well tolerated, but an uncomfortable shortness of breath (dyspnea) is present. Because of the potential lethal consequences of an aspirated prosthesis, it should always be considered and evaluated whenever a prosthesis is lost.





Axial CT with contrast, showing TEP in the stomach





Causes of voice prosthesis leak

There are two patterns of voice prosthesis leak-leak through the prosthesis and leak around it.

Leakage through the voice prosthesis is predominantly due to situations in which the valve can no longer close tightly. This may be due the following: colonization of the valve by a biofilm of fungus; the flap valve may get stuck in the open position; a piece of food, mucus, debris, or hair (in those with a free flap) stuck on the valve (can be addressed by brushing and flushing the prosthesis); development of high pressure in the esophagus when swallowing ( can be addressed by replacing the valve with one with increased resistance such as Activalve or Dual Valve) , or the device coming in contact with the posterior esophageal wall. Leakage is more likely to occur in those who have dentures, are immunocompromised, receive antibiotic or steroid therapies, and during radiation treatment. Inevitably, all prostheses will fail by leaking through, whether from Candida biofilm colonization or simple mechanical failure. 







                     Leak through the voice prosthesis

Reflux often contributes to early valve breakdown which may result in leakage through the TEP. It may also lead to tracheoesophageal puncture tissue changes, such as enlargement of the tract or granulation tissue, possibly leading to leakage around the prosthesis.

If there is continuing leakage through the prosthesis from the time it is inserted, the problem is generally caused by the flap's valve remaining open because of negative pressure generated by swallowing. Esophageal dysmotility is the main cause for reduced swallow pressure and occurs if the esophageal contractions are not strong enough, are absent, or are not synchronized properly. Low esophageal pressure can even cause the TEP to open inadvertently or close insufficiently during deep inhalation or swallowing leading to leakage. This can be corrected by using a prosthesis that has a greater resistance ( e.g.. Activalve, Dual Valve). Activalve is made of fluroplastic that resists destruction, has magnetic valve closure, and generally last longerThe trade-off is that having such a voice prosthesis may require more effort when speaking. It is nevertheless important to prevent chronic leakage that can lead to aspiration into the lungs.


Leakage around the voice prosthesis is less common and requires management by an otolaryngologist and/or SLP, and can lead to prosthesis dislodgement. It is mainly due to TEP tract dilation or the inability to grip the prosthesis. It has been linked to shorter prosthesis life time. It may occur when the puncture, that houses the prosthesis widens. During insertion of the voice prosthesis, some dilation of the puncture takes place, but if the tissue is healthy and elastic, it should shrink back after a short time. The inability to contract back can be associated with gastroesophageal reflux (GERD), poor nutrition, alcoholism, hypothyroidism, improper puncture placement, incorrectly fitted prosthesis, TEP tract trauma, local granulation tissue, recurrent or persistent local or distant cancer, past radiation treatment and radiation necrosis. 




 



Leak around the voice prosthesis 


Granulation around the prosthesis is usually caused by the irritation associated with the presence of prosthesis, especially when it is fitting too tight. It can be removed surgical and the fitness of the prosthesis should be reassessed.


Leakage around the prosthesis can also occur when the prosthesis’ diameter is too small, or the prosthesis is too long for the user’s tract. Whenever this occurs, the voice prosthesis moves back and forth in the tract (pistoning) thereby dilating the tract. The tract should be measured and a prosthesis of more appropriate length should be inserted. In this circumstance leakage should resolve within 48 hours. If the tissue around the prosthesis does not heal around the shaft within this time period, comprehensive medical evaluation is warranted to determine the cause of the problem.
  
Another cause of leakage around the prosthesis is the presence of narrowing (stricture) of the esophagus. The narrowing of the esophagus forces the laryngectomee to swallow harder, with greater force so that the food/liquid goes through the stricture. Esophageal dilation may help stop the leaking. Other causes of elevated swallow pressure include pharyngo-esophageal spasm, or external compression on the esophagus (e.g., osteophytes). The excess swallowing pressure pushes the food/liquid around the prosthesis. 

  Several procedures have been used to treat persistent leakage around the prosthesis. These include temporary removal of the prosthesis and replacement with a smaller-diameter catheter to encourage spontaneous shrinkage; using customized prostheses; placing a purse-string suture around the puncture; injection of gel, collagen or micronized AlloDerm® ( LifeCell, Branchburg, N.J. 08876); cauterize with silver nitrate or electrocautery; autologous fat transplantation;  inserting a larger prosthesis to stop the leak; allowing the puncture to close after removing the prosthesis or closing it surgically; and performing flap reconstruction followed later by preforming a new puncture. 

Treatment of reflux (the most common cause of leakage) can allow the esophageal tissue to heal. Treatment and prevention of granulation tissue is discussed below. 

Increasing the diameter of the prosthesis is generally not recommended. Generally a larger diameter TEP is heavier than a smaller one, and the weakened tissue is often not able to support a bigger device, making the problem even worse. 

Some, however, believe that using a larger diameter prosthesis reduces the speaking pressure (larger diameter allows better airflow) which allows greater tissue healing to occur while when the underlying cause (most often reflux) is treated.

The use of a prosthesis using a larger esophageal and/or tracheal flange may be helpful, as the flange acts as a washer to seal the prosthesis against the walls of the esophagus and/or trachea, thus preventing leakage.

Both types of leakage can cause excessive, strenuous, coughing which may even lead to development of abdominal wall and inguinal hernias. The leaked fluid can enter the lungs, causing aspiration pneumonia. Any leakage can be confirmed by direct visualization of the prosthesis while drinking colored liquid. If leakage occurs and cannot be corrected after brushing and flushing the voice prosthesis, it should be changed as soon as possible.

Uncontrolled gastro esophageal reflux can limit the voice prosthesis life span. It is advisable to treat gastro esophageal reflux to prevent prosthesis failure.

With the passage of time, a voice prosthesis generally tends to last longer before it begins to leak. This is because the swelling and increased mucus production are reduced as the airway adapt to the new condition. Improvement is also due to better prosthesis management by laryngectomees as they familiarize themselves with their device.

One’s SLP can assist in finding the best TEP which is is often a process of trial and error. Patients with a TEP need to be followed by an SLP because of normal changes in the tracheo-esophageal tract. Re-sizing of the tract may be needed as it can change in length and diameter with time. The length and diameter of the prosthesis' puncture generally change over time as the swelling generated by creation of the fistula, surgery and radiation gradually decreases. This require repeated measurements of the length and diameter of the puncture tract by the SLP who can select a properly sized prosthesis using a voice prosthesis-dilator and sizing device. (See pictures bellow)




Voice prosthesis fistula dilator

Voice prosthesis sizing device (Bloom-Singer)

 .

One of the advantages of having a voice prosthesis is that it can assist in dislodging food stuck in a narrow throat. When food get stuck above the prosthesis, trying to speak or blowing air through the voice prosthesis, or flushing the prosthesis with water using flushing bulb can sometimes force the stuck food upward and relieve the obstruction.

The prosthesis may have to be changed if there is an alteration in the quality of the voice especially when the voice becomes weaker or one needs more respiratory effort to speak. This may be due to yeast growth which interferes with the opening of the valve.








A voice prosthesis inside the tracheo-esophageal puncture 






What to do if the indwelling voice prosthesis leaks


To check if the voice prosthesis is leaking and if the leak is around or through it, one can view it through a mirror after swallowing liquid. Persistent leakage of the voice prosthesis into the trachea induces cough especially when liquids are ingested. The leakage carries several risks which include:
  • Development of aspiration pneumonia
  • Clogging of HME
  • Social embarrassment
  • Anxiety
  • Temporary increase of blood pressure and pulse
  • Avoiding food and liquid intake causing dehydration and weight loss
  • Emergence of inguinal hernia
  • Urinary incontinence ( involuntary leakage of urine)
A leak through the voice prosthesis can take place when a piece of dry mucus, a food particle, or hair (in those with a free flap) prevents a complete closure of the prosthesis's valve. Cleaning the prosthesis by brushing and flushing it with warm water (see previous section) can remove these obstructions and stop the leakage. 

If the leakage through the voice prosthesis happens within three days after its insertion it may be due to a defective prosthesis or one that was not placed correctly. It takes some time for the yeast to grow.  If the prosthesis leaks when new, it is due to another cause. In addition to brushing and flushing with warm water, cautiously rotating the prosthesis a couple of times to dislodge any debris may help. If the leak persists the voice prosthesis should be replaced.

Steps to stop the leak through the voice prosthesis include:
  • Attempting to stop the leak by cleaning and brushing (see below)
  • Stopping the leak by inserting an adequate plug (see below) into the prosthesis whenever consuming fluids or leaving it permanently and switching to alternate speaking method (e.g., esophageal speech, electrolarynx)
  • Consuming viscous fluids that generally do not leak (i.e., yogurt, jelly, soup, oatmeal, etc) through or around the prosthesis (see below)
  • Drinking small amount of fluid without strong effort while lying down, swallowing the liquid as if it is a food item, speaking a few words each time fluids are swallowed, can reduce or prevent the liquids from leaking into the trachea   
The easiest way of temporarily stopping the leak until the voice prosthesis can be changed is to use a plug. A plug is specific for the type and width of each voice prosthesis. It is a good to obtain a plug from the prosthesis' manufacturer and have it handy. Sealing the prosthesis will prevent speaking but it allows eating and drinking without leakage. The plug can be removed after eating and drinking and reinserted as needed. Some individuals use a small cotton swab inserted into the prosthesis lumen to absorb the leaking fluid. This method runs the risk of dropping the swab into the trachea. These are temporary solutions until the voice prosthesis is replaced.

It is important to stay well hydrated despite the leakage. Avoiding fluid losses in hot weather through perspiration by staying in an air-conditioned environment and ingesting liquids in a way that is less likely to leak are helpful. Drinks that contain caffeine increase urination and should be avoided.

Speaking a few words each time fluids are swallowed, leaning back, or lying down can reduce or even prevent the liquids to leak into the trachea.Viscous (thickened) fluids tend not to leak and consuming them can provide essential liquids despite the leak. Many food items that contain large amount of liquids are more viscous (i.e., jelly, soup, oat meal, toast dipped in milk, yogurt) and are therefore less likely to leak through the prosthesis. On the other hand coffee and carbonated drinks are more likely to leak. Fruits and vegetables (e.g., watermelon, apples, etc.) contain large amount of water. The way to find out what works is to cautiously try any of these.

These measures can be used to keep well-hydrated and nourished until the voice prosthesis can be changed. 





A Provox voice prosthesis 



Cleaning the voice prosthesis and preventing leaking

It is very important to keep the voice prosthesis clean to insure its proper function and durability. When not cleaned properly the prosthesis can leak, and the ability to speak can be compromised or weakened. It is recommended that the inner space (lumen) of the voice prosthesis be cleaned at least twice a day (morning and evening), and preferably after eating because this is the time when food and mucus can become trapped. Sometimes mucus blocks the prosthesis (when getting up in the morning or after eating) which interfere with the ability to speak. Cleaning is especially helpful after eating sticky foods or whenever one’s voice is weak.

The valve of a newly installed voice prosthesis may initially be stuck. The SLP can lubricate the valve with a small amount of olive oil, using the cleaning brush. This is done with great caution to prevent aspiration of the oil.

A prosthesis cleaning brush and flushing bulb are used in cleaning the prosthesis. 


                                               



Maintenance and prevention of leakage guidelines are:
  1. Before using the brush provided by the manufacturer, dip it in a cup of hot water and leave it there for a few seconds. 
  2. Initially the mucus around the prosthesis should be gently cleaned using tweezers preferably with rounded tips. Following that, the manufacturer-provided brush should be inserted into the prosthesis (not too deep) and rotated several times. The brush should be thoroughly washed with warm water after each cleaning. The prosthesis is then flushed twice with warm (not hot) water using the manufacturer’s provided bulb. 
  3. Take the brush out and rinse it with hot water and repeat the process 2-3 times until no material is brought out by the brush. Wait until the brush is not hot any more before brushing the prosthesis again. Be careful not to insert it beyond the voice prosthesis inner valve to avoid traumatizing the esophagus with excessive heat.
  4. Gently flush the voice prosthesis twice with water or saline using the bulb provided by the manufacturer using warm (not hot!) potable water. To avoid damage to the esophagus sip the water first to make sure that the water temperature is not too high. The flushing bulb should be introduced into the prosthesis opening while applying slight pressure to completely seal off the opening. The angle of inserting the end of the tip of the bulb varies between individuals. (The SLP can provide instructions how to choose the best angle.) Flushing the prosthesis should be done gently because using too much pressure can lead to splashing of water into the trachea. If flushing with water is problematic, the flushing can be done with air.
  5. Dip the voice prosthesis brush in a small amount of mycostatin suspension, Chlorhexidine Gluconate  (Pyridex) or vinegar and brush the inner voice prosthesis before going to sleep. (A homemade suspension can be made by dissolving a quarter of a mycostatin tablet in 3-5 cc water). This would leave some of the suspension inside the voice prosthesis. The unused suspension should be discarded. Do not place too much mycostatin, Chlorhexidine Gluconate (Pyridex),  or vinegar in the prosthesis to prevent dripping into the trachea. Speaking a few words after placing the suspension will push it towards the inner part of the voice prosthesis

  6. Prevent formation of biofilm by yeast and bacteria (see next section) 

Warm water works better than room temperature water in cleansing the prosthesis probably because it dissolves the dry secretions and mucus and perhaps even flushes away some of the yeast colonies that had formed on the prosthesis.


The manufacturers of each voice prosthesis brush and flushing bulb provide directions of how to clean them and when they should be discarded. The brush should be replaced when its threads become bent or worn out.


The prosthesis brush and flushing bulb should be cleaned with hot water, when possible, and soap and dried with a towel after every use. One way to keep them clean is to place them on a clean towel and expose them to sunlight for a few hours, on a daily basis. This takes advantage of the antibacterial power of the sun’s ultraviolet light to reduce the number of bacteria and fungi.

Placing 2-3 cc of sterile saline in the trachea at least twice a day (and more if the air is dry), wearing an HME 24/7 and using a humidifier can keep the mucus moist and reduce the clogging of the voice prosthesis.





A voice prosthesis cleaning brush (Atos Medical )






A voice prosthesis flushing bulb (Atos Medical)





A sterile saline vial for respiratory tract use ("Saline bullet")





Watch a video how to brush the voice prosthesis




Watch a video how to flush the voice prosthesis




Preventing biofilm of yeast and bacteria from growing on the voice prosthesis

Overgrowth of yeast and bacteria in the form of a biofilm ( a thin, slimy film of microorganisms that adheres to a surface) on the voice prosthesis is one cause of the prosthesis leaking and thus failing. Nevertheless, it takes some time for yeast and bacteria to grow in a newly installed voice prosthesis and form the biofilm  that prevent its valve’s from closing completely. Accordingly, failures immediately after voice prosthesis installation are unlikely due to yeast growth. Formulation of biofilm on the valve may also lead to increased air flow resistance making it harder to speak.

The presence of yeast should be established by the person who changes the failing voice prosthesis  This can be done by observing the typical yeast (Candida) colonies that prevent the valve from closing and, if possible, by sending a specimen from the voice prosthesis for fungal culture.


The antifungal agents Mycostatin and Clotrimazole (Mycelex) troches, can be used to prevent voice prosthesis failure due to yeast. They are available with a prescription in the form of a suspension or tablets ( Mycostain) and troches (Mycelex.) Mycostatin tablets can be crushed and dissolved in water. There is anecdotal information that apple cider vinegar that is known to inhibit candida growth can be used to gargle and be swallowed to prevent yeast growth on the TEP.

Automatically administering anti-fungal therapy (i.e., mycostatin) just because one assumes that yeast is the cause of voice prosthesis failure may be inappropriate without proof. It is expensive, may lead to the yeast developing resistance to the agent, and may cause unnecessary side effects. 

There are, however, exceptions to this rule. These include the administration of preventive anti-fungal agents to diabetics; those receiving antibiotics; chemotherapy or steroid; and those where colonization with yeast is evident (coated tongue etc.).

There are several methods that help prevent yeast from growing on the voice prosthesis:

  • Reduce the consumption of sugars in food and drinks, brush your teeth well after consuming sugary food and/or drinks.
  • Brush your teeth well after every meal and especially before going to sleep.
  • Clean your dentures daily.
  • Diabetic should maintain adequate blood sugar levels.
  • Take antibiotics and corticosteroids only if they are needed.
  • After using an oral suspension of an antifungal agent, wait for 30 minutes to let it work and then brush your teeth. This is because some of these suspensions contain sugar.
  • Dip the voice prosthesis brush in a small amount of mycostatin suspension, Chlorhexidine Gluconate  (Pyridex), or vinegar and brush the inner voice prosthesis before going to sleep. (A homemade suspension can be made by dissolving a quarter of a mycostatin tablet in 3-5 cc water). This would leave some of the suspension inside the voice prosthesis .The unused  suspension should be discarded. Do not place too much mycostatin or vinegar in the prosthesis to prevent dripping into the trachea. Speaking a few words after placing the suspension will push it towards the inner part of the voice prosthesis.  
  • Consume probiotics by eating active-culture yogurt and/or a probiotic preparation.
  • Gently brush the tongue if it is coated with yeast (white plaques). 
  • Replace the toothbrush after overcoming a yeast problem to prevent re colonizing  with yeasts
  • Keep the prosthesis brush clean






Candida albicans as seen under the microscope 






The use of probiotics such as Lactobacillus acidophilus to prevent yeast overgrowth


A probiotic that is often used to prevent yeast overgrowth is a preparation containing the viable bacteria Lactobacillus acidophilus. There is no FDA approved indication to use Lactobacillus acidophilus to prevent yeast growth. This means that there were no controlled studies to ensure its safety and efficacy. L. acidophilus preparations are sold as a nutritional supplement and not as a medication. The recommended dosage of L. acidophilus is between 1 and 10 billion bacteria. Typically, acidophilus tablets contain somewhere within this recommended amount of bacteria. Dosage suggestions vary by tablet's brand, but generally it is advised to take between one and three L. acidophilus tablets daily.

Although generally believed to be safe with few side effects, oral preparations of L. acidophilus should be avoided in people with intestinal damage, a weakened immune system, or with overgrowth of intestinal bacteria. In these individuals this bacterium can cause serious and sometimes life threatening complications. This is why individuals should consult their physician whenever this live bacteria is ingested. It is especially important in those with the above conditions.




Lactobacillus as seen under the microscope






Granulation tissue: prevention and treatment

Granulation tissue interfering with the function of the voice prosthesis and also cause leakage around the prosthesis.  

Formation of granulation tissue around the trachea-esophageal fistula has been reported at a rate of approximately 5% of users of voice prosthesis. (see picture below) This is mostly seen in conjunction with a repeated removal and insertion of the voice prosthesis, using a prosthesis that is too short and irritates the mucous, gastroesophageal reflux, and local infection.  

Temporarily insertion of a longer prosthesis and treating the infection with a broad-spectrum antibiotic can lead to disappearance of the granulation. Topical application of antibiotics and/or steroid creams using a swab has also been advocated. Granulation tissue that persists and/or interferes with speech or insertion of the prosthesis can be cauterized using either electric, chemical, laser methodology. When gastroesophageal reflux is suspected, anti-reflux medication and other intervention (see Medical issues page) can be helpful.





Granulation tissue around the voice prosthesis. 




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