Safety information

The US Food and Drug Administration (FDA) has made a commitment to inform the public about urogynecologic surgical mesh for prolapse and stress urinary incontinence (SUI), and maintains information on their website for patients about SUI and the use of surgical mesh for repair of SUI.

The information provided by the FDA for mesh used in the treatment of stress urinary incontinence is not specific to one company or specific product line. To ensure you receive the full list of potential risks for specific mesh devices, please discuss with your healthcare provider.

The information below has been taken directly from the FDA’s website regarding urogynecologic surgical mesh. Please note that these excerpts include information on mesh used to treat stress urinary incontinence and pelvic organ prolapse.

Use the links below to access the latest from the FDA regarding urogynecologic surgical mesh:

• Urogynecologic Surgical Mesh Implants
• Considerations about Surgical Mesh for SUI
• Information for Patients for SUI

Important safety information

Altis^® Single Incision Sling System
Important Safety Information

Stress urinary incontinence is a condition in which urine involuntarily leaks at times of increased pressure on the bladder (e.g., coughing, sneezing, laughing, lifting heavy objects, exercise). Stress urinary incontinence can be treated with a surgical procedure in which a mesh sling is implanted to act as a “hammock” to support the urethra, the tube that connects to the bladder that carries urine outside the body. An incontinence sling surgery involves anesthesia and may require an overnight hospital stay.

The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from the urethra not closing properly (urethral hypermobility) and/or weakness of the urethral sphincter (intrinsic sphincter deficiency (ISD)).

Your physician should advise that the Altis Single Incision Sling System is not for females who have the following: are pregnant or have desire for future pregnancy • potential for further growth (e.g., adolescents) • known active urinary tract infection and/or infection in operative field • taking blood thinning medication (anti-coagulant therapy) • abnormal urethra (e.g., fistula, diverticulum) • any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement, and • sensitivity/allergy to polypropylene or polyurethane.

Discuss with your Physician:

• The reason for choosing a mesh sling including the warnings, precautions and risks associated with its use
• Alternative incontinence treatments that may be appropriate
• The Altis sling to be implanted is permanent
• Serious mesh associated complications may result in one or more revision surgeries
• Partial or complete removal of the mesh may not always be possible or advisable as it may not fully correct these complications
• New onset (de novo) complications and recurring or worsening SUI can occur
• There may be unresolved pain with or without mesh explant and varying degrees of scarring may occur
• Certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, mesh sling exposure or other complications

Potential additional risks versus benefits of using Altis should be considered in patients with one or more of the following: age-related underlying conditions • autoimmune disease • coagulation disorder • connective tissue disorder • debilitated or immunocompromised state • diabetes • pelvic radiation therapy or chemotherapy • physical characteristics (e.g., body mass index) • renal insufficiency • smoking-related underlying conditions, or • urinary tract anomalies.

Any future pregnancy could negate the benefits of this surgical procedure. Patients should report bleeding, pain, abnormal vaginal discharge or signs of infection at any time.

Complications are known to occur and may be immediate or delayed, localized or systemic, new onset (de novo) or worsening, acute or chronic, transient or permanent, new onset (de novo) or continuing, worsening, transient, or permanent.

Potential complications may include but are not limited to:

Abnormal vaginal discharge Abscess Adhesion Allergic reaction, hypersensitivity, or abnormal (maladaptive) immune response Bladder symptoms (e.g., increased daytime frequency, urgency, nocturia (urinating more than once per night), overactive bladder, urinary incontinence Bleeding/hemorrhage or hematoma Delayed/impaired/abnormal wound healing Dyspareunia (painful intercourse) Exposure, extrusion or erosion of mesh sling or suture into the vagina or other structures and organs Fistula formation (abnormal connection or passageway that forms between two structures in the body) Granuloma (small area of inflammation)/scar tissue formation Hispareunia (male partner pain with intercourse) Infection

Inflammation/irritation Necrosis (tissue death) Neuromuscular disorder Pain Palpable mesh (able to be felt by patient and/or partner) Pelvic/urogenital pain Perforation or injury to adjacent muscles, nerves, vessels, structures, or organs (e.g., bone, bladder, urethra, ureters, bowel, vagina) Scarring Seroma (fluid buildup at site of surgery) Sexual dysfunction Sling migration (movement) Suture exposure Ureteral obstruction Urinary tract infection Vaginal tightening/shortening Voiding symptoms (e.g., dysuria (painful urination), urinary retention, incomplete emptying, bladder outlet obstruction, straining, position-dependent voiding, slow stream) Wound dehiscence (re-opening of surgical incision)

This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a mesh sling is right for you.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN
PM-03328 02/2024