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:

Important safety information

Altis^® Single Incision Sling System
Patient Materials (Direct to Consumer)

Important Safety Information:

Stress urinary incontinence is a condition in which urine involuntarily leaks out of the urethra (the tube that brings urine from the bladder to the outside of the body) during times of high pressure such as coughing, sneezing or exercising. Stress urinary incontinence can be treated with a surgical procedure in which an incontinence sling is implanted to support the urethra. An incontinence sling is intended to provide support to the urethra to help stop urine from leaking and to help control when urine is emptied from the bladder.

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)).

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), intraoperative urethral injury, any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement, and sensitivity/allergy to polypropylene.

Check with your Physician on the warnings, precautions and risks associated with the use of this mesh sling.

Check with your Physician on:

Alternative incontinence treatments that may be appropriate
The reason for choosing a mesh sling procedure
The postoperative risks and potential complications of transvaginal mesh sling surgery
The mesh sling to be implanted is a permanent implant
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 parts of the mesh sling, or the entire mesh sling, and complete removal of the mesh sling may not always be possible
Individuals who have varying degrees of collagen laydown that may result in scarring
Certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, or other complications and adverse events, as with all surgical procedures

You should consider the risks and benefits of the Altis Single Incision Sling System.
Any future pregnancy could negate the benefits of this mesh sling surgical procedure.
You should report any bleeding, pain, abnormal vaginal discharge or sign of infection that occur at any time.

A mesh sling is implanted inside the vagina to support the urethra. The operation to place a mesh sling is considered major surgery.

A mesh sling procedure is a surgical solution that has risks such as: mesh extrusion, pelvic/urogenital pain, groin pain, hip pain, urinary retention, bleeding, new onset (de novo) urgency, delayed wound healing, painful intercourse (dyspareunia), inflammation, nausea, overactive bladder, pain, pelvic hematoma, reaction to antibiotic, slight discomfort upon return to work, urinary tract infection, urine stream decreased, and voiding dysfunction.

Adverse events are known to occur with transvaginal synthetic mesh sling procedures and implants. Adverse events following mesh implantation may be new onset (de novo), persistent, worsening, transient, or permanent.

Additional potential complications 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, new onset (de novo) and/or worsening painful intercourse (dyspareunia), neuromuscular symptoms (acute or chronic), pain, partner pain (acute or chronic) 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 (pocket of fluid build-up), sling migration, suture erosion, bladder storage dysfunction (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence), ureteral obstruction, urinary tract infection, voiding symptoms (e.g., painful urination (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 mesh sling.

Complete removal of the mesh 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 explanation.

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 02/2021