Product

Instruction for use

Good to know

Summary of clinicals trials

Do not use the Femsoft insert if :
• You currently have a bladder or urinary tract infection.
• You currently have or previously have had scarring or narrowing of the urethra (urethral stricture), surgery to enlarge the bladder (bladder augmentation), x-ray treatments to the pelvic area for cancer (pelvic radiation), or other conditions where passage of a catheter through the urethra is not clinically advisable.
• You have ongoing conditions related to the urinary tract, for example chronic, painful bladder inflammation (interstitial cystitis), compromised urinary tract tissue, poorly functioning (neurogenic) bladder, overflow incontinence, kidney stones, bleeding, etc.
• You are not able to fight an infection (immuno-compromised), have an artificial heart valve or other implanted device (e.g., breast implant or artificial joint) or have any other condition that puts you at an increased risk from an infection.
• You are allergic to or cannot take any form of antibiotic medication.
• You are currently taking a blood-thinning medication.

Temporarily STOP USING the FemSoft Insert and CONTACT your physician if:
• A bladder or other urinary tract infection is present (see ‘When to Contact Your Physician’ below). • Any type of vaginal or venereal infection is present.
• You notice any unusual bleeding from the vaginal area (that is not menstrual) or blood in your urine.
• You know or think you are pregnant. If any of these conditions occur, your physician will let you know when it is safe to start using the FemSoft Insert again.

CAUTION

If you are pregnant or think you are, call your physician as soon as possible to talk about whether you can use the FemSoft Insert. Use of the insert has not been studied during pregnancy, and its effects are unknown.

If you have any other questions about whether you should use the FemSoft Insert, ask your physician.

WARNINGS AND PRECAUTIONS
Using the FemSoft Insert incorrectly can cause infection, irritation, or injury. Also, if you frequently had urinary tract infections in the past, you might have an increased risk of infection with use of the FemSoft Insert. Here are some important points to remember to help you use the FemSoft Insert correctly.

To prevent infection:
• WASH hands thoroughly with soap and water prior to handling a FemSoft Insert.
• DO NOT use a FemSoft Insert if the package is open or damaged prior to use.
• DO NOT use a FemSoft Insert if it has been contaminated (touched or dropped) prior to use.
• DO NOT re-use a FemSoft Insert.
• CHANGE the FemSoft Insert and empty your bladder when you feel the need to void and at least once every 6 hours. The FemSoft Insert is not intended to prevent normal urination.
• DO NOT use the FemSoft Insert for 24 hours every day, as this will increase the risk of complications such as infection. Remove at night for sleep.
• DRINK an adequate amount of fluids when using the FemSoft Insert. Normally a person should drink 6-8 glasses of water a day. To prevent irritation or injury:
• DO NOT force the FemSoft Insert on insertion.
• DO NOT use the FemSoft Insert during sex.

Before using the FemSoft Insert you should read this entire booklet to ensure a full understanding of the correct use and the potential complications that can occur. You should also receive personal instructions from your physician to help you learn how to insert and remove the device and about the complications that can occur.

POTENTIAL COMPLICATIONS AND RISKS
Potential complications from use of the FemSoft Insert are listed below. Some of these could require treatment by a physician. Other unknown complications could also occur. • Bacteria in the urine may occur.
• Bladder infection may occur. If left untreated, bladder infection could lead to more serious complications.
• The FemSoft Insert could move (migrate) into the tube that drains urine from the body (urethra) or bladder.
• Injury or irritation to the urethra or bladder may result from use. Injury or irritation may cause bleeding or bloody urine.
• Some women may experience pain or uncontrolled bladder contraction (bladder spasm) during use.
• Some women may not be able to retain the FemSoft Insert.
• The silicone sleeve of the FemSoft Insert may break resulting in release of mineral oil into the bladder, urethra or external genitalia.

WHEN TO CONTACT YOUR PHYSICIAN
The following guidelines will help you decide what to do for the common problems that can occur with use of the FemSoft Insert. If you experience any other problem that you believe is associated with the use of the FemSoft Insert, you should discontinue its use and consult your physician. You may also call the
FemSoft Resource Center at 1-800-FemSoft (1-800-336-7638).

Infection du Système Urinaire
Urinary Tract Infection
Discontinue use of the FemSoft Insert and promptly contact your physician if you experience signs of a urinary tract infection including burning on urination, foul smelling urine, bloody urine, back pain, pelvic pain, frequent need to urinate during the day or at night, or unexplained fever.

Mild Irritation, Light Spotting of Blood or Discomfort with Insertion or Removal
If these symptoms occur, the FemSoft Insert should be discontinued for 1-2 days until the symptoms completely resolve. Use of the FemSoft Insert may then be resumed. If the symptoms reoccur frequently or persist 1-2 days after discontinuing FemSoft Insert use, contact your physician.

Persistent Heavy Spotting of Blood or Bloody Urine
Discontinue use and promptly contact your physician.

FemSoft Insert Migration
If you suspect that a FemSoft Insert has moved into your urethra or bladder, first void with a moderately full bladder and check to see if the FemSoft Insert was expelled in your urine.If not, contact your physician.

FemSoft Insert Expulsion or Urine Leakage with a FemSoft Insert in Place
Contact your physician for an evaluation to determine if you are using the proper technique to insert the FemSoft Insert or if the FemSoft Insert size should be adjusted.

FemSoft Insert Breakage
The sleeve of the FemSoft Insert can break releasing mineral oil into the bladder, urethra or external genitalia. If this occurs, remove the FemSoft Insert. Oil released into the bladder or urethra will be expelled with subsequent voiding. Use a tissue to wipe oil from external tissues and insert a new FemSoft Insert.