Aris® Transobturator Kit
BRIEF STATEMENT
Physician Facing
Indications
The Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The introducer is a surgical instrument designed to assist in correct placement of a sling.
Contraindications
It is the responsibility of the physician to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. The Aris Transobturator Kit is contraindicated for use in patients with the following conditions:
• Pregnancy or desire for future pregnancy
• Potential for further growth (e.g., adolescents)
• Known active urinary tract infection and/or infection in operative field
• Taking anti-coagulant therapy
• Abnormal urethra (e.g., fistula, diverticulum)
• Intraoperative urethral injury
• Any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement
• Sensitivity/allergy to polypropylene
Warnings and Precautions
It is the responsibility of the physician to advise the prospective patients or their representatives, prior to surgery, of the warnings and precautions associated with the use of this product and the associated surgical risks.
Warnings
The Aris Transobturator Kit should only be used by physicians familiar with the surgical procedures and techniques involving transvaginal placement of non-absorbable, synthetic mesh slings and who have adequate education and experience in the treatment of female SUI.
A thorough assessment of each patient should be made to determine the suitability of a synthetic mesh sling procedure.
The patient should be counseled that alternative incontinence treatments may be appropriate, and the reason for choosing a mesh sling procedure should be explained.
Obtain patient consent prior to surgery and ensure that the patient has an understanding of the postoperative risks and potential complications of transvaginal mesh sling surgery.
Patient counseling should include a discussion that the sling to be implanted is a permanent implant and that some complications associated with the implanted mesh sling may require additional surgery; repeat surgery may not resolve these complications. Serious adverse tissue responses or infection may require removal of mesh, and complete removal of the sling may not always be possible. Individuals may have varying degrees of collagen laydown that may result in scarring.
As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, or other complications and adverse events.
The risks and benefits of using Aris should be considered in patients.
Any future pregnancy could negate the benefits of this surgical procedure. Patients should report any bleeding, pain, abnormal vaginal discharge or sign of infection that occur at any time.
Do not use product that has damaged or opened packaging, or has expired, as sterility may be compromised.
The procedure to insert the Aris sling requires good knowledge of pelvic anatomy and the correct use of the introducer needles in order to avoid damage to adjacent anatomical structures.
Potential Complications
Adverse events are known to occur with transvaginal synthetic sling procedures and implants. Adverse events following mesh implantation may be de novo, persistent, worsening, transient, or permanent.
Adverse events may include but are not limited to: abscess (acute or delayed), adhesion/scar formation, allergy, hypersensitivity or other immune reaction, bleeding, hemorrhage or hematoma, dehiscence, delayed wound healing, extrusion, erosion or exposure of mesh sling into the vagina or other structures or organs, fistula formation, infection, inflammation (acute or chronic), local irritation, necrosis, de novo and/or worsening dyspareunia, neuromuscular symptoms (acute or chronic), pain (acute or chronic), partner pain and/or discomfort during intercourse, perforation or injury of soft tissue (e.g., muscles, nerves, vessels), structures, or organs (e.g., bone, bladder, urethra, ureters, vagina), seroma, sling migration, bladder storage dysfunction (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence), ureteral obstruction, urinary tract infection, voiding symptoms (e.g., dysuria, urinary retention, incomplete emptying, straining, positional voiding, weak stream), granulation tissue formation, palpable mesh (patient and/or partner), sexual dysfunction, vaginal discharge (abnormal) and vaginal scarring or tightening.
The occurrence of these events may require one or more revision surgeries, including removal of the sling.
Complete removal of the sling may not always be possible, and additional surgeries may not always fully correct the complications.
There may be unresolved pain with or without mesh sling explantation.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Minneapolis, MN
04/28/2021
PM-04430
