Safety Information

Page Last Updated: 03/26/2018

This information can be accessed electronically by clicking here.²⁶

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

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:

• Transvaginal mesh to treat POP
• Transabdominal mesh to treat POP
• Mesh sling to treat SUI

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

This information can also be accessed electronically by clicking here.²⁶

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345219.htm

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 safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year. Longer follow-up data is available in the literature, but there are fewer of these long-term studies compared to studies with one-year follow-up.
• The safety and effectiveness of mini-slings for female SUI have not been adequately demonstrated. Presently, it is unclear how mini-slings compare to multi-incision slings with respect to safety and effectiveness for treating SUI. Additional studies may help the agency to better understand the safety and effectiveness of these devices.
• Mesh sling surgeries for SUI have been reported to be successful in approximately 70 to 80 percent of women at one year, based on women’s reports and physical exams. Similar effectiveness outcomes are reported following non-mesh SUI surgeries.
• The use of mesh slings in transvaginal SUI repair introduces a risk not present in traditional non-mesh surgery for SUI repair, which is mesh erosion, also known as extrusion.
• Erosion of mesh slings through the vagina is the most commonly reported mesh-specific complication from SUI surgeries with mesh. The average reported rate of mesh erosion at one year following SUI surgery with mesh is approximately 2 percent. Mesh erosion is sometimes treated successfully with vaginal cream or an office procedure where the exposed piece of mesh is cut. In some cases of mesh erosion, it may be necessary to return to the operating room to remove part or all of the mesh.
• The long-term complications of surgical mesh sling repair for SUI that are reported in the literature are consistent with the adverse events reported to the FDA.
• The complications associated with the use of surgical mesh slings currently on the market for SUI repair are not linked to a single brand of mesh.

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

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345230.htm

Recommendations for Patients:

Before surgery:

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:

• What surgical or non-surgical treatment options are available and what do you recommend to treat my SUI?
• Have you had specialized training in the surgical treatment of SUI, and if so, what type of training have you had with this particular product and/or procedure?
• What can I expect after surgery and what is the recovery time?
• If I also have pelvic organ prolapse, will that change how you treat my SUI?
• What if the surgery doesn’t correct my problem?
• Which side effects should I report to you after the surgery?
• Are you planning to use a mesh sling in my surgery? If so:
  • How often have you performed this surgery using this particular product? What results have your other patients had with this product?
  • What are the pros and cons of using a mesh sling in my particular case? How likely is it that my repair could be successfully performed without using a mesh sling?
  • Are recovery times different for mesh sling surgery compared to non-mesh surgery?
  • Will my partner be able to feel the mesh sling during sexual intercourse?
  • If I have a complication related to the mesh sling, how likely is it that the complication can be resolved? Will you treat it or will I be referred to a specialist experienced with mesh sling complications?
  • Is there patient information that comes with the product, and can I have a copy?

After surgery:

• Continue with annual check-ups and follow-up care, notifying your health care provider if complications develop, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain during sexual intercourse. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
• If you have complications or other symptoms:
  • Discuss complications and treatment options with your health care provider. Only your health care provider can give you personalized medical advice.
  • Consider getting a second opinion from a surgeon who specializes in female pelvic reconstruction if you are not satisfied with your discussion with your health care provider.
• Let your health care provider know you have a mesh sling, especially if you plan to have another surgery, plan to become pregnant or have other medical procedures.
• If you have had SUI surgery but do not know whether your surgeon used a mesh sling, ask your health care provider.
• Talk to your health care provider about any additional questions you may have.

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:

• 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), 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.

Minneapolis, MN
PM-03328 01/23/2018