Información de seguridad importante - Bulkamid (2024)

FAQs

Can Bulkamid be removed? ›

It is very uncommon for urinary retention to persist. In such a case further surgery to dilate the urethra or remove the Bulkamid implant may be required. This occurs in only a few patients; 5%.

The procedure takes about 10 minutes, but you will usually be asked to arrive about one hour prior to allow for your hospital admission and preparation time. You will then be asked to stay after the procedure until you have passed a good volume of urine. Allow at least 3-4 hours in total at the hospital.

Short term side effects, however, may include mild pain after the procedure, difficulty emptying your bladder, bladder urgency and urinary tract infection. There have been reports of women experiencing mild burning or bleeding when urinating, however, these normally resolve after a couple of days.

If Bulkamid does not reduce your stress urinary incontinence symptoms enough, you may need a further top up injection. This is usually done within the first year following the initial procedure. If after your top up you feel Bulkamid is not for you, you can discuss other treatment options with your doctor.

As the Bulkamid gel is designed to work permanently, the success of surgery is well maintained for at least seven years. Over time, if the natural muscle sphincter were to weaken further, a top-up injection of Bulkamid should easily restore continence.

Do not force the Bulkamid Rotatable Sheath into the urethra if the tissue is damaged. Do not inject Bulkamid Hydrogel if the tissue is damaged. Bulkamid Urethral Bulking System should not be used in patients with urethral or bladder neck strictures until the strictures have been corrected.

Bulkamid is usually done under local anaesthetic, in which case you will be awake during the procedure but should experience minimal discomfort. You can discuss the anaesthetic options with your doctor.

Bulkamid^® is a promising bulking agent for women with stress urinary incontinence. It is safe, durable, and easily adminstered under local anaesthesia with an initial success rate of over 80%.

Bathing. You may shower starting the day after surgery. You may gently wash the genital area with soap and water. After showering, pat the area dry.

Bulkamid^® received CE approval in 2006 and FDA approval in 2020 for patients with SUI or stress-dominant MUI [24]. Bulkamid^® is a non-particulate hom*ogeneous polyacrylamide hydrogel composed of 2.5% cross-linked polyacrylamide and 97.5% water.

Does Medicare cover bulkamid procedure? ›

Yes – Bulkamid is covered by Medicare.

In comparing bulkamid vs sling, injections of bulking agents facilitate a quicker recovery time to daily activities compared to a sling procedure, making it a more suitable choice for patients leading active lifestyles.

How long does it take for Bulkamid to work? Bulkamid has a recovery period of less than 24 hours, and begins to work immediately.

The eCoin system, approved by the U.S. Food and Drug Administration in March 2022 for the treatment of urgency urinary incontinence, is based on tibial nerve stimulation. The tibial nerve is involved in movement and feeling in the legs and feet, and it also influences the nerves that control the bladder.

Patients should be counseled that one or more repeat Bulkamid Hydrogel injection procedures may be required to achieve dryness or a satisfactory level of improvement in urinary incontinence.

Sometimes it is possible to remove mesh in the bladder using a laser during a telescopic examination of your bladder (cystoscopy). This can usually be done as a day case.

Urethral caruncle removal.

If nonsurgical options don't work, a surgeon can remove the growth under local anesthesia, sedation or general anesthesia. It's important to note that, even with surgical removal, there's still a chance for urethral caruncle recurrence (return).

Sling removal is safe and associated with a minimal rate of complications. Removing the tape causes resolution of most of the complications, but SUI recurs or worsens.