Important Safety Information

Europe/Rest of World (English)
IMPORTANT SAFETY INFORMATION

Indications:

Bulkamid® Hydrogel is intended to be used as a urethral bulking agent for the treatment of female urinary incontinence where the stress component is significant. Bulkamid® Hydrogel is intended for female patients, above the age of 18 years.

Intended Users:

Bulkamid® Uretheral Bulking System is intended for use by qualified physicians, e.g. gynaecologists, urologists, or urogynaecologists.

Contraindications:

Bulkamid® Urethral Bulking System must not be used in patients suffering from acute infection in the urinary tract (cystitis and urethritis), having active Herpes Genitalis, or having damaged tissue in the urethra.

Warnings:

Patients receiving treatment with blood thinners have an increased risk of bleeding (haematoma or urethral bleeding).

Precautions:

If the patient has undergone major dental work or surgery, Bulkamid® should not be injected until the patient is fully recovered. If the patient needs surgery or major dental work post Bulkamid® Hydrogel injection, antibiotic treatment to reduce risk of infection should be considered by physician. Patients with acute or chronic infection in other sites of the body must be treated with caution. Only patients with well-controlled diabetes should be considered for Bulkamid® Hydrogel injection. The procedure may cause urinary tract infections and scratches in urethra and bladder as with any other minimally invasive procedure in the urinary tract. Prophylactic antibiotics is recommended. It is possible that inflammatory changes seen at the site of implant may later be misinterpreted for other pathology. Bulkamid® must not be injected into other sites of the body. Safety and effectiveness of the device has not been established in patients during pregnancy, delivery or lactation. Bulkamid® should be used with caution in patients on immunosuppressive therapy. Safety has not been established for patients with autoimmune diseases. Safety and effectiveness of Bulkamid® Hydrogel have not been established in patients under 18 years.

Adverse Events:

General side effects normally associated with any surgical implantation procedure or local anaesthesia also apply to the placement of Bulkamid® Hydrogel. Specifically, the following side effects may be associated with the use of the device system; postoperatively, transient symptoms such as painful urination (dysuria), Blood in urine (haematuria), swelling (oedema), urinary tract infection and acute retention and pain during voiding may occur, scratching of the urethral mucosal may occur during the procedure, and long-term adverse events such as non-acute retention, Bacterial infection (abscess formation), tissue hardening (fibrosis), migration (material leakage) and tissue injury (necrosis) are possible but rare.

Results and experiences may vary and are unique to each patient. The efficacy of the device may diminish over time and no promise or guarantee is made about specific results or experiences.

Australia (English)
IMPORTANT SAFETY INFORMATION

Indications:

Intended Users:

Bulkamid® Uretheral Bulking System is intended for use by qualified physicians, e.g. gynaecologists, urologists, or urogynaecologists.

Contraindications:

Warnings:

Patients receiving treatment with blood thinners have an increased risk of bleeding (haematoma or urethral bleeding).

Precautions:

Adverse Events:

General side effects normally associated with any surgical implantation procedure or local anaesthesia also apply to the placement of Bulkamid® Hydrogel. Specifically, the following side effects may be associated with the use of the device system: postoperatively, transient symptoms such as painful urination (dysuria), blood in urine (haematuria), swelling (oedema), urinary tract infection and acute retention and pain during voiding may occur. Scratching of the urethral mucosal may occur during the procedure. Long-term adverse events such as non-acute retention, Bacterial infection (abscess formation), tissue hardening (fibrosis), migration (material leakage) and tissue injury (necrosis) are possible but rare.

Results and experiences may vary and are unique to each patient. The efficacy of the device may diminish over time and no promise or guarantee is made about specific results or experiences.

United States/Canada (English)
IMPORTANT SAFETY INFORMATION

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.

Europe/Rest of World (German)
WICHTIGE SICHERHEITSINFORMATIONEN

Indikationen:

Das Bulkamid® Hydrogel ist für den Gebrauch als urethrales Bulking-Mittel zur Behandlung der Harninkontinenz bei Frauen vorgesehen, wenn eine signifikante Belastungskomponente vorliegt. Das Bulkamid® Hydrogel ist für Patientinnen ab 18 Jahren bestimmt.

Anwenderzielgruppe:

Das urethrale Bulkamid® Bulking-System ist für die Anwendung durch qualifizierte Ärztinnen/Ärzte, z. B. in den Bereichen Gynäkologie, Urologie oder Urogynäkologie bestimmt.

Kontraindikationen:

Das urethrale Bulkamid® Bulking-System darf nicht bei Patientinnen mit akuter Harnröhrentzündung (Cystitis und Urethritis), aktivem Herpes genitalis oder geschädigtem Gewebe in der Harnröhre angewendet werden.

Warnhinweise:

Patientinnen, die mit Blutverdünnern behandelt werden, haben ein höheres Risiko für Blutungen (Hämatom oder Harnröhrenblutung).

Vorsichtshinweise:

Nach größeren zahnärztlichen oder chirurgischen Eingriffen darf Bulkamid® erst nach vollständiger Genesung der Patientin injiziert werden. Wenn die Patientin nach der Injektion des Bulkamid® Hydrogels einen chirurgischen Eingriff oder eine größere zahnärztliche Behandlung benötigt, sollte die Ärztin/der Arzt eine Antibiotikatherapie zur Verringerung des Infektionsrisikos in Betracht ziehen. Patientinnen mit akuten oder chronischen Infektionen an anderen Körperstellen müssen mit Vorsicht behandelt werden. Die Injektion des Bulkamid® Hydrogels darf nur bei Patientinnen mit gut eingestelltem Diabetes mellitus in Betracht gezogen werden. Wie bei jedem anderen minimalinvasiven Eingriff im Harnweg kann der Eingriff Harnwegsinfektionen und Kratzer in Harnröhre und Blase verursachen. Eine prophylaktische Antibiose wird empfohlen. Es ist möglich, dass entzündliche Veränderungen an der Implantationsstelle später als andere Krankheiten fehlinterpretiert werden. Bulkamid® darf nicht an anderen Stellen des Körpers injiziert werden. Die Sicherheit und Wirksamkeit des Produkts bei Frauen während der Schwangerschaft, Entbindung oder Stillzeit wurden nicht untersucht. Bulkamid® ist bei Patientinnen, die eine immunsuppressive Therapie erhalten, mit Vorsicht anzuwenden. Die Sicherheit für Patientinnen mit Autoimmunerkrankungen ist nicht erwiesen. Sicherheit und Wirksamkeit von Bulkamid® Hydrogel sind bei Patientinnen unter 18 Jahren nicht erwiesen.

Unerwünschte Ereignisse:

Allgemeine Nebenwirkungen, die normalerweise mit chirurgischen Implantationsverfahren oder einer Lokalanästhesie verbunden sind, gelten auch für das Platzieren des Bulkamid® Hydrogels. Insbesondere die folgenden Nebenwirkungen können mit der Anwendung des Produktsystems im Zusammenhang stehen; postoperativ können vorübergehende Symptome wie schmerzhaftes Wasserlassen (Dysurie), Blut im Urin (Hämaturie), Schwellungen (Ödeme), Harnwegsinfektionen sowie akuter Harnverhalt und Schmerzen beim Wasserlassen auftreten; während des Eingriffs kann es zu Kratzern an der Harnröhren¬schleimhaut kommen, und langfristige unerwünschte Ereignisse wie nicht akuter Harnverhalt, bakterielle Infektion (Abszessbildung), Gewebeverhärtung (Fibrose), Migration (Materialaustritt) und Gewebeschädigung (Nekrose) sind möglich, aber selten.

Ergebnisse und Erfahrungen können variieren und sind patientenspezifisch. Die Wirksamkeit des Produkts kann im Laufe der Zeit nachlassen, und es wird keine Zusage oder Garantie für bestimmte Ergebnisse oder Erfahrungen gegeben.