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“Renew Inserts are a new way to manage ABL. They are very soft, comfortable, convenient, safe, and easy to use. Most of my patients have been thrilled with the results.”

– Emily S. Lukacz, M.D Division Director, Female Pelvic Medicine and Reconstructive Surgery UC San Diego Health System

Indications for Use

The Renew Insert is indicated for the management of Accidental Bowel Leakage (ABL) due to bowel incontinence.

The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.

Description

Renew Inserts are made of soft silicone and are safe and 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.

Benefits

A clinical study* demonstrated that the Renew Insert helps prevent Accidental Bowel Leakage, delivering the following benefits:

  • A median reduction of 81.8% in the frequency of ABL episodes
  • Over 91% of the Renew Insert users demonstrated a ≥ 20% reduction in ABL episodes
  • A median reduction of 29.4% in the Wexner score
  • Overall satisfaction among the majority of Insert users was high, with 91.4% rating the overall experience and ease of use as a 9.5 (median) on a 10 point scale
Warnings and Precautions

Bowel incontinence may be medically treated.
The Renew Insert is not intended to replace surgical options to treat ABL.
Consult your doctor for professional advice.
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 experience the following:

  • Bleeding hemorrhoids
  • Rectal bleeding or bloody stool
  • Anal/rectal pain, irritation, spasms, fissure or tearing
  • 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.

Possible Side Effects
  • False urge to empty your bowels.
  • Mild irritation of anal area.
Risks

There were no reported severe, serious or unanticipated adverse events. Almost all (98.7%) of the adverse events possibly related to the Renew Insert were rated as ‘mild’ and included the sensation of urge, irritation or soreness around the anal area. Displacement of the Insert may occur when the lower (bottom) disk of the Insert becomes temporarily displaced and moves upward into the anus. Displacements of the Insert were reported by 23.9% of the study participants. Instances of displacement of the Insert were resolved predominately by natural expulsion during subsequent bowel movements.

Prescribing Information

Renew Inserts are currently available in most states in the US. Please contact us at info@renew-medical.com to check if they are available in your state.

Renew Inserts are available in 2 sizes: Regular and Large. Start your patients with the Regular size Renew Insert. If the Regular size comes out at unexpected times or if your patient still experiences leakage, they should try the Large size Renew Insert. A convenient Starter Pack containing both sizes of Inserts is intended to help your patient determine their proper size when initiating use.

Please download and print out the Renew Insert Prescription Form. Fax the completed form to Bedard Medical Supplies using the fax number on the form. Bedard Medical Supplies will contact your patient to collect payment from them and deliver Renew Inserts directly to their home.

Please give a copy of the completed prescription form to your patient to go along with their insurance claim. Using this prescription form and completing it in detail will assist your patient in claiming insurance reimbursement.

Contact us with any questions: info@renew-medical.com

Download Rx Form

Item Description Product Code Units per Pack Price
Renew Inserts – Starter Pack 702 10 (5 Regular, 5 Large) $32.90
Renew Inserts – Regular Size 706 30 $98.70
Renew Inserts – Large Size 707 30 $98.70

Insurance Reimbursement

Many new medical devices and procedures are considered “not medically necessary” by the insurance companies and denied reimbursement as a result. This is not unusual for products coming to market within the first few years. This may be the case for Renew Inserts. Bedard Medical Supplies is able to fill your patient’s prescription for Renew Inserts, but payment for the product and claims submission to the insurance company are the patient’s responsibility.

Clinical Samples

To obtain clinical samples for your practice, please complete the form below:

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This web page is only intended for healthcare professionals in the USA.

*Renew clinical study CLD210 results as published in Diseases of the Colon & Rectum 2015; 58: 892–898