The FDA has made a commitment to inform the public about urogynecologic surgical mesh for 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 any company or specific product line. To ensure you receive the full list of potential risks for any specific mesh device, please discuss with your health care 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.
Page Last Updated: 03/26/2018
Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.
Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.
Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine).
Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.
Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed to treat pelvic floor disorders with surgical mesh:
Each of these procedures has unique risks and benefits and it is important not to confuse the procedures and the risks and benefits.
In this website, the FDA describes POP and SUI, the different surgical and non-surgical treatment options, recommendations for health care providers that treat women with POP and/or SUI, recommendations for patients who are considering surgery for these conditions and steps to report problems to the FDA. This information is to help patients make informed decisions about their health care and to facilitate a discussion between patients and their health care providers about treatment options. The information provided on this website is not meant to replace a discussion with your health care provider.
Page Last Updated: 01/07/2018
Mesh sling procedures are currently the most common type of surgery performed to correct SUI. Based on industry estimates, there were approximately 250,000 of these procedures performed in 2010.
While all surgeries for SUI carry some risks, it is important for you to understand the unique risks and benefits for surgical mesh slings used in SUI repair.
In order to better understand the use of surgical mesh slings for SUI and evaluate their safety and effectiveness, the FDA held a panel meeting of scientific experts (Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee) in September 2011 and conducted a systematic review of the published scientific literature from 1996 to 2011. For surgical mesh slings used for SUI, both the panel and the FDA’s review found that:
The FDA conducted a review of Medical Device Reports (MDRs) received from Jan. 1, 2008 through Sept. 30, 2011. During this time frame the FDA received 1,876 reports of complications associated with surgical mesh devices used to repair SUI.
The most common complications reported through MDRs for surgical mesh slings for SUI repair, in descending order of frequency, include: pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI.
MDRs are submitted to the FDA by medical device manufacturers, importers, health care facilities, health care professionals and patients. MDR information is used to monitor marketed medical devices, and contribute to the detection of potential product-related safety issues as well as the benefit-risk assessments of these products. While MDRs are a valuable source of information, this passive surveillance system has notable limitations, including the potential submission of incomplete or inaccurate data, under-reporting of events, lack of denominator data (number of implants), and the lack of report timeliness.
Page Last Updated: 01/07/2018
Recommendations for Patients:
Ask your surgeon about all SUI treatment options, including non-surgical options and surgical options that do and do not use mesh slings. It is important for you to understand why your surgeon may be recommending a particular treatment option to treat your SUI.
Any surgery for SUI may put you at risk for complications, including additional surgery. One complication that may occur when mesh slings are used is vaginal mesh erosion, which could require additional surgery to resolve.
If mesh erosion occurs through the vaginal tissue, it is possible that men may experience penile irritation and/or pain during sexual intercourse.
Ask your surgeon the following questions before you decide to have SUI surgery:
Please see below for specific product information.
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 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:
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), 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, suture erosion, bladder storage dysfunction (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence), ureteral obstruction, 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 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 explantation.
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.