Macroplastique Risks

As with any treatment, there are risks involved.  It is important to discuss risks and side effects with your doctor before undergoing any type of medical treatment.

Risks following a Macroplastique treatment include pain related to the procedure (which can be controlled with pain medication), a small amount of blood in your urine, having to use the bathroom more often or more urgently, delayed voiding, painful urination, and/or urinary tract infection. There is also a potential risk related to receiving anesthesia during the treatment.

If after 48 hours you have urination that is difficult, frequent, or painful, or there is blood in your urine, contact your doctor immediately. These may be signs of other more serious problems.

An additional risk is that you may experience no benefit from Macroplastique treatment.  This could happen if Macroplastique is placed too deeply in the tissue, thereby creating poor bulking around the urethra. Also, if you have a different type of incontinence (i.e., urge incontinence) or your incontinence condition worsens (i.e., due to urethral hypermobility), Macroplastique may not be an effective treatment for you.

In the clinical trial, 122 patients were treated with Macroplastique and followed for 12 months after the last treatment. The most common side effects (adverse events) reported are listed below.

Adverse EventNumber of Patients
Post-operative catheterization* 43 in 100
Urinary tract / bladder infection
(0 – 365 days post treatment)
25 in 100
Urinary retention 21 in 100
Painful urination (Dysuria) 19 in 100
Blood in urine
(Hematuria / Transient hematuria)
19 in 100
Pain at implantation site 16 in 100
Frequency 12 in 100
Strong desire to urinate, but no incontinence episodes (Urgency) 12 in 100
Slowed urine stream 7 in 100
Incomplete bladder emptying 6 in 100
Urge incontinence 6 in 100
Hesitancy 5 in 100

*Instructions to the doctors allowed them to perform catheterizations as a routine part of the procedure.

Many of the side effects reported in the clinical study occurred within 7 days after treatment and resolved within 30 days. You should talk to your doctor about these side effects and how they can be resolved.