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medingenuityContigen Implants

Is my incontinence treatable? | What is contigen implant? | How do contigen implants work? | Are there other treatments which can help cure my incontinence? | When should contigen implants not be used? | What should I consider before choosing contigen implants as a treatment for my incontinence? | What should I be cautious about before undergoing contigen implant treatment? | What tests will I need before the procedure? | How is the contigen implant procedure performed? | Is more than one treatment needed? | What results can I expect after treatment? | Contigen consent form

Introduction

We have given you this information taken from the Contigen Implant Patient Information pamphlet to make sure you understand the treatment that is being recommended to help correct your urinary incontinence.

This pamphlet contains brief explanations of the different methods of treatment which are presently used to treat your type of incontinence. You will also learn important facts about the Contigen implant. What it is? How it works? What you might expect during and after treatment. In addition, you will be given information about what side effects may occur as a result of treatment with the implant.

After you have read this information, your doctor will review its contents with you to ensure that you understand the information you have been given.

Is my incontinence treatable?

Many thousands of people feel they must resort to absorbent or sanitary products to avoid situations where embarrassing leakage may occur. Contrary to popular opinion, however, most incontinence is treatable and manageable. After tests have shown what type of incontinence you are experiencing, your doctor will be able to tell you if it is treatable and which treatment option is appropriate for you.

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What is contigen implant?

Contigen implants are used to treat incontinence when leakage is caused by lack of control or poor control of urine flow from the bladder. The Contigen implant is made from collagen obtained from cows and then highly purified. Collagen is a natural protein that provides texture and shape to tissues under the skin.

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How do contigen implants work?

Contigen implants are injected with a syringe into the tissues around the urethra. Once injected, the Contigen implant adds "bulk" to the tissues surrounding the urethra so that it can close tightly enough to prevent urine from leaking out. The opening of the bladder into the urethra is closed off, but then expands normally when you intentionally empty your bladder.

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Are there other treatments which can help cure my incontinence?

There are ways other than Contigen implants for treating incontinence. Not all of these are right for every person. Your doctor will help you decide what is right for you. It will depend on your medical history, your general health, and the results of the tests.

There are two kinds of surgery that are intended for long-term treatment. One creates a sling and is a procedure for female patients only. This surgical procedure is successful in about 80-95% of the cases, and approximately 15% of patients experience complications. The other procedure implants an artificial sphincter prosthesis. Implantation of an artificial sphincter improves incontinence in approximately 90% of men and 95% of women. Serious complications are experienced in approximately 10% of patients.

Your doctor can explain these surgical procedures to you in more detail if you wish to know more about them.

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When should contigen implants not be used?

Contigen implant treatment should not be started in any person who:

  • has been incontinent for less than one year
  • has shown improvement in their incontinence in the last year.

In addition, Contigen implant treatment is contraindicated (cannot be used) in any person who:

  • has a positive reaction to the skin test;
  • ever had an allergic reaction to a material made with collagen from cows; (Some materials used in surgery, such as sutures, are made with collagen from cows. Getting injections ("shots") to lessen allergy to meat or who will soon get these injections)
  • had a severe allergic reaction that was a threat to life;
  • is severely allergic to many substances;
  • has an acute irritation or infection of the kidney, bladder or the urethra; (the urine outlet path from the bladder).

Contigen implant must be used with caution in a person:

  • who is receiving treatment that lowers the body's immunity (including steroid medication);
  • who has experienced allergic reactions.

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What should I consider before choosing contigen implants as a treatment for my incontinence?

There are some things you should be aware of before having Contigen implant treatment.

If there is a question regarding your skin test reaction, your doctor may have to place another skin test on the other forearm. This, too, must be watched for four weeks before Contigen implant treatment is started.

A small number of patients who have received collagen injections for correction of scars and wrinkles have been found to have connective tissue diseases (such as rheumatoid arthritis, scleroderma, dermatomyositis, polymyositis, and systemic lupus erythematosus) after the injections. Experts have not determined whether the collagen injections caused the diseases. They have reported that the number of people with polymyositis / dermatomyositis in the group who had collagen treatments may be higher than should be expected, when compared to the general population of untreated people.

One to two percent of patients treated with implants in the skin became sensitive to collagen and had redness, swelling, hardness, and or hives where collagen was implanted.

Side effects seen with skin implants of collagen may develop with Contigen implants. These include: rare abscesses, hardening of tissues, scars, allergic reactions, flu-like symptoms, fever, rashes, itching, blurred vision, tingling, and aches and pains.

People who have rheumatoid arthritis, juvenile rheumatoid arthritis or scleroderma, especially, may be sensitive to Contigen.

Persons who are allergic to beef may be allergic to Contigen.

If the outlet from your bladder is very small or your urethra is very narrow (called a stricture), you may need to have this corrected before you are treated with Contigen implants.

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What should I be cautious about before undergoing contigen implant treatment?

There are some cautions you should know about before undergoing Contigen implant treatment. There is a chance that infections such as urinary tract infection (UTI) or blood in the urine will develop after Contigen implant treatment. Because no pregnant women and only a small number of children were included in the clinical studies, it has not been established whether collagen implants may be used safely and effectively in pregnant women, or in children less than 18 years old.

The safety of injected collagen implants for dermal (skin) applications has been studied only since 1976, and for urethral injection only since 1985. Long-term safety and effectiveness for urological use has not yet been established.

What are some of the side effects that may be caused by contigen treatment?

Almost any medical treatment has some risks. Side effects and complications related to Contigen implants treatment that were experienced by patients in the clinical study included:

  • Urinary retention (inability to pass urine). This was experienced by approximately 8% of the patients and generally was treated with catheterization.
  • Worsening of incontinence. Approximately 7% of treated patients experienced worsened incontinence lasting one to six months, which was improved with further treatment. Approximately 3% of patients experienced worsened incontinence which did not improve at all during their study participation.
  • Infection in the bladder or urine pathways. This was experienced by approximately 4% of the patients and was treated with medication.
  • Blood in the urine for a short time after treatment. This occurred in approximately 2% of the patients.
  • Inflammation of the tip of the penis. This occurred in approximately 1% of the male patients.
  • Pain or discomfort at the Contigen implant injection site. This occurred in approximately 1% of the patients treated.
  • Too tight a closure (or obstruction) of the opening from the bladder. This occurred in approximately 1% of the patients.
  • Sensitivity reaction (such as abscess) in the tissues where the Contigen implant was injected. This was experienced by approximately 1% of the patients and was treated with medication.

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What tests will I need before the procedure?

Tests must be done to help ensure that the Contigen implant will be a proper and safe treatment for you. These will include a physical exam, a medical history, tests of urine flow (called urodynamics), and a skin test.

The skin test is done to make sure that you do not have an allergy to Contigen implants. For this test, a small amount of collagen is injected under the skin of your forearm. The skin test site is watched for four weeks. Pay special attention to your skin test site during the first three days, since most reactions occur during this time period. If the skin there turns red, swells or itches, notify your doctor.

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How is the contigen implant procedure performed?

Using a syringe and needle, your doctor injects the Contigen implant into the tissues around your urethra. The area is first anesthetized (deadened to pain). A cystoscope (a hollow tube used for seeing into the urethra and bladder) is inserted into the urethra.

Contigen implant is then injected into the tissues surrounding the urethra either from inside the urethra (by inserting the needle through the scope) or from outside the body through the skin and tissues. All the while, the doctor observes the area through the scope to make sure the proper amount of Contigen Implant is being injected to allow the bladder opening to close and keep urine from leaking out.

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Is more than one treatment needed?

You should understand that Contigen implant therapy is not a one-time or permanent therapy and that most patients will need additional treatment sessions to achieve and maintain improvement or dryness.

In general, women need fewer treatments than men.

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What results can I expect after treatment?

Women

Based on clinical studies, women tend to do better than men following treatment with Contigen implants. If you are a woman, there is a greater than 80% chance that you will experience some type of improvement (having less leakage or even becoming dry) following treatment. If you do improve, the chance that you will do so after only one or two treatments is greater than 90%.

All the women in the clinical study began to improve with one to four treatments. There is about an 80% chance that you will remain improved for one year after having one to four treatments with some retreatments. There is a 75% chance,or more, that you will remain improved for two years after having one to four treatments with some retreatments.

Women treated with Contigen implants have about a 70% chance of becoming completely dry after treatment. If you do become dry, the chance that you will do so after only one or two treatments is about 80%. If you become dry after only one or two treatments, the chance that you will maintain your dryness without additional treatments is about 70%. This means that, for a woman, the chance of becoming dry with only one or two treatments and not needing additional treatments is about 40%.

For women, the chance that you will remain dry for one year after having one to seven treatments (no retreatments) is about 50%, and the chance that you will remain dry for two years after one to seven treatments (no retreatments) is about 40%.

Experience indicates that patients who have not improved at all after five treatment sessions will not benefit from Contigen implant and should not receive further treatment.

Men

If you are a man, there is a greater than 70% chance that you will experience some type of improvement (having less leakage or even becoming dry) following treatment. If you do improve, the chance that you will do so after only one or two treatments is greater than 80%. There is a 70% chance, or more, that you will remain improved for one year after having one to seven treatments with some retreatments. There is a 60% chance that you will remain improved for two years after having one to seven treatments with some retreatments. Men treated with Contigen implant have about a 30% chance of becoming completely dry after treatment. If you become dry, the chance that you will do so after only one to two treatments is about 60%. If you become dry after only one or two treatments, the chance that you will maintain your dryness without additional treatments is about 40%. This means that, for a man, the chance of becoming dry with only one or two treatments and not needing additional treatments is about 8%. However, the chance that you will remain dry for one year after having one to seven treatments (no retreatments) is about 35%, and the chance that you will remain dry for two years after one to seven treatments (no retreatments) is about 25%.

Experience indicates that patients who have not improved at all after five treatment sessions will not benefit from Contigen implant and should not receive further treatment.

Suggested Points For Review Of Contigen Implant Information Pamphlet

The following may be of assistance in reviewing with treatment candidates important information from the Contigen Implant Patient Pamphlet:

1. Before you can be treated with Contigen implants, you must have a skin test done to make sure you don't have a reaction to the material.

  • Do you have any allergies?
  • Have you ever had a severe allergic reaction?
  • Have you ever had an allergy to beef or to cow's milk?
  • If you ever had surgery, did you experience a reaction to any of the materials or medicines used during that surgery?
  • If you ever had plastic surgery, did you experience any reactions or side effects after the surgery?
  • Have you ever had a serious infection of the bladder or urinary tract?

2. Do you understand that the Contigen implant is injected with a syringe, and that the area around the urethra must be anesthetized before treatment?

3. Is it clear to you that one or more side effects are possible with Contigen implant treatment?

4. Did the Contigen Implant Pamphlet we provided make it clear to you that you may need more than one treatment to correct your incontinence? ( Ask if you did not receive a pamphlet.)

5. Do you understand that while your incontinence may be improved, it is possible that you may not be completely dry after Contigen implant treatment?

6. Do you understand that even after improvement or dryness is achieved, you may have occasional regressions that require treatment?

7. Do you have any questions about the other forms of incontinence treatment and why they may or may not be appropriate for you?

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Contigen Consent Form

As with any drug, there may be adverse effects due to CONTIGEN IMPLANT. You are encouraged to report any reactions to your physician or one of his medical staff promptly for evaluation. Of course you realize that no guarantees can be made that your incontinence will be cured or will not return in the future. A return of the incontinence may prompt other treatment which might include surgery, or other types of medications.

The More Common Side Effects And/Or Risks Of Contigen Injections

1. Inability to urinate, requiring a catheter for a period of time

2. Bladder infections

3. Blood in the urine

4. Injury at injection site

5. Continued incontinence requiring additional treatments or other treatments.

The More Serious Side Effects Of Contigen.

Uncommon allergic reaction, which can occur from most injectable drugs, ranging from skin rashes of several types; wheezing with shortness of breath; drop in blood pressure and possible loss of consciousness.

Do not hesitate to contact your physician and his medical staff if you are concerned about any unusual or severe reactions.

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Reprinted with permission from Dialog Medical, dialogmedical.com.

 

 

 

 

 

 

 

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