Renew Anal Insert (Large) FG731

Renew Inserts are made of soft silicone and are comfortable to use in the rectum. Renew Inserts and the removable applicator are both single-use and non-sterile. Renew Inserts are available in 2 sizes: Regular and Large.

Possible Side Effects

False urge to empty your bowels.

Mild irritation of anal area.

Warnings and Precautions

Bowel incontinence can also be medically treated.
The Renew Insert is not intended as a replacement replace surgical options to treat ABL.
Consult your doctor for professional advice prior to using this product
Do not use if you have an allergy to silicone. Do not use with suppositories.

Discontinue using the Renew Inserts and consult your doctor if you have any of the following issues

•Bleeding haemorrhoids
•Bloody stool or rectal bleeding
•Anal or rectal pain, irritation, spasms, fissure or tearing
•You have undergone rectal surgery within the past 4 weeks
•Displacement of the Insert upward into the anus and it is not expelled with the next bowel movement

Do not use if opened or damaged. Single use only. Non–sterile.

FREQUENTLY ASKED QUESTIONS

1. Have Renew Inserts been clinically tested?
Yes. Clinical studies in the USA have demonstrated that the Renew Inserts are safe and reduce Accidental Bowel Leakage by 81.8%*.
2. Are Renew Inserts comfortable to insert and wear?
Yes. Clinical studies show Renew Inserts are: soft, fit the contours of the body, comfortable to wear and easy to use*. Inserting a Renew Insert properly will not cause discomfort. Just follow the step-by-step instructions. If you still experience discomfort, discontinue use.
*U.S. Clinical Study (Renew 210 CLD) published in Dis Colon Rectum 2015; 58: 892-898.
3. How do I know when the Renew Insert is properly in place?
When the Renew Insert is properly in place, the top disk is resting just inside the rectum and the bottom disk is just outside the anus. You should not feel any discomfort.
4. How long can I wear a Renew Insert?
Renew Inserts may be worn continuously, day and night. A single Renew Insert can be worn until your next bowel movement, or changed as desired. After one is expelled, you may replace it with a new Insert. Never use more than one insert at a time.
5. What are some ways to easily place the Renew Insert?
You may want to sit on the toilet and insert from the front or back, or lie down on a bed. You should use whichever insertion position is most comfortable for you. Avoid multiple insertion attempts to limit the exposure of stool to other parts of the body; use a new Insert if this happens.
6. Can a Renew Insert get lost inside my body?
No. Clinical research has shown that Renew Inserts come out with a person’s next bowel movement*. The Renew Insert is designed so the top and bottom disks hold it in place in the anal canal between the rectum and anus. In the unlikely event a Renew Insert moves into the anus, it will be naturally expelled with your next bowel movement.
7. What if the Renew Insert comes out when I go to the toilet and pass wind (gas) or urinate?
If this happens, simply replace it with a new Renew Insert. If you are using a Regular size Renew Insert and this happens frequently, you may want to try the Large size Renew Insert.
8. Will I be able to pass wind (gas) with the Renew Insert in place?
Yes. The Renew Insert still allows for the passage of wind (gas). If you are using a Large size Renew Insert and feel discomfort from wind (gas), try a Regular size Renew Insert.
9. Can I bathe and be physically active when I’m wearing my Renew Insert?
Yes. You can do all of your activities while using a Renew Insert.
10. Should I flush the applicator and Renew Insert down the toilet?
Flushing of the applicator and the Renew Insert is not recommended. Dispose of the used Renew Insert in household waste.

SIZING

Renew Inserts come in two sizes, Regular and Large. Start with the Regular size Renew Insert. If the Regular size comes out at unexpected times or if you experience leakage, try the Large size Renew Insert.

PREPARATION

Step 1. Do not use a Renew Insert package unless it is fully sealed. Wash your hands. Peel back the
top of the package fully, to expose the Renew Insert.
Step 2. Place your index finger into the white removable applicator and lift the Insert out of its package. Step 3. Sit relaxed on a toilet and insert from the front or back. Other common insertion positions are to raise yourself up onto one hip (while sitting on the toilet) or lie down on a bed (if this is more comfortable). Position the top disc of the Renew Insert so it’s lightly resting on the anus. Note: If the Insert falls off the applicator prior to insertion, discard it and use a new one.

INSERTION

Step 4. Relax your muscles and gently slide the Renew Insert into the anus until you feel the applicator touch
the anus.
Step 5. Gently withdraw the applicator. The bottom disk of the Renew Insert should be resting just outside the anus.
Step 6. Discard the applicator in a waste receptacle. Wash your hands after use. The Renew Insert is now properly in place and sealing from the inside to help prevent ABL.
REMOVAL
Step 7. Simply grasp the the bottom disk outside the anus and pull it down to remove the Renew Insert Dispose of the Renew Insert in household waste. Wash your hands after direct contact with the used Insert.

REPLACEMENT

Step 8. For optimal protection, use a new Renew Insert after each bowel movement.

US CLINICAL TRIAL SUMMARY
A clinical study has shown that Renew Inserts are safe and work as indicated. Three sites enrolled 97 subjects in this study. Safety data was analysed on 91 treated subjects who used Renew Inserts. Reduction in the frequency of Accidental Bowel Leakage (ABL) episodes was measured by comparing pre- and post-treatment results on 85 subjects who used the Renew Insert for at least 1 week or more during the 12-week Treatment Period. Reduction in the Wexner Score (an assessment of bowel incontinence) was analyzed on 77 subjects who had both a pre- and post-treatment Wexner score.
Benefits
The clinical study demonstrated that the Renew Insert helps prevent Accidental Bowel Leakage (ABL), delivering the following benefits:

•Over 91% of the Renew Insert users demonstrated a ≥ 20% reduction in ABL episodes