Important Safety Information

Important Safety Information about DEFLUX®

DEFLUX is indicated for vesicoureteral reflux. Patients should not receive DEFLUX (hyaluronic acid/dextranomer) if they have any of the following conditions: primary refluxing megaureters with distal stenosis, uncontrolled voiding dysfunction.

Do not inject DEFLUX if the patient is known to be allergic to hyaluronic acid-based products or dextran.

There is a risk of urinary tract infection or bleeding that is associated with urological procedures performed under sterile conditions, specifically cystoscopy, used to inject DEFLUX.

More than 6 mL of DEFLUX should not be injected in the same treatment session.

The safety and effectiveness of DEFLUX in pregnant or lactating women has not been established. Treatment with DEFLUX in combination with drugs and other medical devices has not been studied.

In clinical investigations, the most common side effects associated with DEFLUX (occurring 1%) were: postoperative dilation of the upper urinary tract that resolves spontaneously within a few days, postoperative dilation of the upper urinary tract with or without hydronephrosis leading to temporary placement of a ureteric stent. In very rare cases of ureteral obstruction, ureteric reimplantation has been required.

The Deflux implant may show up on medical imaging as distal ureteral calculi. Future physicians should be informed that the patient had a treatment with Deflux.

DEFLUX should only be administered by qualified surgeons experienced performing urologic procedures.

For product information, adverse event reports, and product complaint reports, contact:

Palette Life Sciences
Medical Information Department- EU

DE: +49 0 800 1813 334
ES: +34 900 993 304
FR: +33 (0) 800 000 013
IT: +39 800 785 440
UK: +44 080 823 4628