Important Safety Information – USA

Indications:

The Bulkamid Urethral Bulking System is indicated for urethral injection for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.

 

Contraindications:

Bulkamid Urethral Bulking System must not be used in patients suffering from acute urinary tract infection.

 

Warnings:

Do not inject Bulkamid Hydrogel intravascularly. Injection of Bulkamid Hydrogel into blood vessels may cause vascular occlusion leading to a possible embolism. Discontinue injection of Bulkamid Hydrogel if the superficial capillaries of the mucosa start to fade in order to avoid ischemia. Prior assessment of the tissue is recommended before introducing the Bulkamid Rotatable Sheath into the urethra. Do not force the Bulkamid Rotatable Sheath into the urethra or inject Bulkamid Hydrogel if the urethral tissue is damaged. The Bulkamid Urethral Bulking System should not be used in patients with urethral or bladder neck strictures until the strictures have been corrected. Use of the Bulkamid Urethral Bulking System in patients with strictures may cause injury and/or urethral obstruction. Over-correction using Bulkamid Hydrogel may lead to obstruction. Patients receiving treatment affecting blood coagulation have an increased risk of hematoma or urethral bleeding, as with any invasive procedure. Do not use Bulkamid Hydrogel in male patients. Testicular abnormalities have been observed in some male animals implanted with Bulkamid; however, their relationship with Bulkamid has not been definitively established.

 

Precautions:

The Bulkamid Urethral Bulking System is only to be administered by a qualified physician, e.g. gynecologist, urologist, or urogynecologist. Safety and effectiveness of Bulkamid have not been established in patients with any of the following conditions: a fragile urethral mucosal lining, urethral hypermobility with a straining angle >30º from horizontal bladder neck, predominant urge incontinence, detrusor overactivity, known polyuria (≥ 3L/24h), unevaluated hematuria, prolapse stage greater than Stage II using the ICS Pelvic Organ Prolapse Quantification (POPQ) exam, BMI >35 kg/m2, neurogenic bladder, or active Herpes Genitalis. Safety and effectiveness of Bulkamid have also not been established for re-injection of Bulkamid Hydrogel less than 4 weeks after initial injection or for patients less than 18 years of age. The effect of Bulkamid has not been evaluated in women during pregnancy, delivery or lactation. The effect of Bulkamid on subsequent pregnancy and delivery, and the impact of subsequent pregnancy on the effect of Bulkamid, is unknown. Therefore, the risks and benefits of the device in women of childbearing potential should be carefully assessed.

 

The procedure may cause urinary tract infections and scratches in the urethra and bladder. Prophylactic use of antibiotics is recommended. Only patients with well-controlled diabetes should be considered for Bulkamid Hydrogel injection. Bulkamid should be used with caution in patients on immunosuppressive therapy. Safety has not been established for patients with autoimmune diseases. Patients with acute or chronic infection in other sites of the body should be treated with caution. If the patient has undergone major surgery or dental work, Bulkamid should not be injected until the patient has fully recovered. Advise patients that if they need to undergo a surgical procedure in the future, especially a dental procedure, there is a risk of infection developing in Bulkamid or near where the Bulkamid was placed. This is due to the possibility of bacteria migrating to the implant, which is the case with many other medical implants. Please consider advising patients that if they require a surgical or dental procedure in the future, they should tell the treating physician that they have a permanent implant and they should discuss the possible need for prophylactic antibiotic therapy with their treating physician.

 

Do not mix Bulkamid Hydrogel with any other substances. Do not inject Bulkamid Hydrogel into sites previously injected with another bulking agent or inject another bulking agent into a site previously injected with Bulkamid Hydrogel. 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.

 

Do not use any other component of the Bulkamid Urethral Bulking System after the expiration date printed on the packaging. All components of the Bulkamid Urethral Bulking System are intended for use in a single patient. Do not re-use. Re-use increases the risk of contamination and thereby increases the risk of infection. All components of the Bulkamid Urethral Bulking System are sterile when supplied. Only use the components if the packaging and products are intact and undamaged. Do not re-sterilize any of the components. After use, syringes and needles should be handled as potential biohazards. Dispose in accordance with accepted medical practice and applicable local, state, and federal requirements.

 

Adverse Events:

Adverse events may include: pain at the implant site, acute retention, urinary tract infection, hematuria, de novo urge incontinence, dysuria, urinary urgency, vaginal infection/irritation/Lichen Sclerosus, and worsening urinary incontinence.

 

Caution: U.S. Federal law restricts this device to sale and use by, or on the order of, a physician.