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 Event | Number 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.
