The FDA has made a commitment to inform the public about urogynecologic surgical mesh for pelvic organ prolapse (POP) and maintains information on their website for patients about POP and the use of surgical mesh for repair of POP.
The information provided by the FDA for mesh used in the treatment of pelvic organ prolapse 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 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 POP
- Information for Patients for POP
Important safety information
Restorelle® Y, Y Contour™, M, L, and XL
Polypropylene Mesh for Sacrocolposuspension/Sacrocolpopexy
Patient Materials (Direct to Consumer)
Important Safety Information:
Pelvic organ prolapse (POP) is a condition in which the muscles of a woman’s pelvis become weak or damaged and can no longer support the pelvic organs (such as the bladder, uterus and rectum), causing them to push into the vagina. This condition can cause pain in the pelvis, discomfort while going to the bathroom and problems with having sex.
Pelvic organ prolapse can be treated with a surgical procedure in which mesh is implanted to support the pelvic organs. Restorelle® Y, Y Contour™, M, L, and XL mesh is a non-absorbable mesh that is surgically implanted through the abdomen (transabdominally) and once implanted into your body is permanent. The mesh is intended to act as a support to the weak or damaged pelvic muscles to prop up the muscles while new tissue grows into the mesh to provide strength and support, preventing the pelvic organs from pushing into the vagina. A mesh is implanted inside the abdomen to support the internal organs. The operation to place a mesh is considered major surgery.
Restorelle Y, Y Contour, M, L, and XL is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (transabdominal placement via laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Restorelle Y, Y Contour, M, L, and XL is not for females who have the following: are pregnant or desire for future pregnancy, potential for further growth (e.g., adolescents), pre-existing local or systemic infection, taking blood thinning medication (anti-coagulant therapy), 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.
The effectiveness of Restorelle Y, Y Contour, M, L, and XL has not been validated by a prospective, randomized clinical trial.
A thorough assessment of each patient should be made to determine the suitability of a synthetic mesh procedure.
Check with your Physician on:
- Alternative pelvic organ prolapse treatments that may be appropriate
- The reason for choosing transabdominal mesh
- The postoperative risks and potential complications of transabdominal mesh surgery
- The mesh to be implanted is a permanent implant
- Some complications associated with the implanted mesh 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, or the entire mesh, and complete removal of the mesh 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
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 Restorelle Y, Y Contour, M, L, and XL should be considered in all patients, taking into account patients with the following underlying conditions:
- Age-related underlying conditions
- Autoimmune disease
- Coagulation disorder
- Connective tissue disorder
- Debilitated or immunocompromised state
- Pelvic radiation therapy or chemotherapy
- Physical characteristics (e.g., body mass index)
- Smoking-related underlying conditions
- Urinary tract anomalies
Any future pregnancy could negate the benefits of this mesh surgical procedure. You should report any bleeding, pain, abnormal vaginal discharge or sign of infection that occur at any time.
Adverse events are known to occur with transabdominal synthetic mesh procedures and implants.
Adverse events following mesh implantation may be new onset (de novo), persistent, worsening, transient, or permanent.
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, bowel obstruction, constipation and/or defecatory dysfunction, fecal incontinence and/or anal sphincter incompetence, ileus, dehiscence, delayed wound healing, extrusion, erosion or exposure of mesh into the vagina or other structures or organs, fistula formation, infection, inflammation (acute or chronic), local irritation, mesh migration, necrosis, new onset (de novo) and/or worsening painful intercourse (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., ligaments, muscles, nerves, vessels), structures, or organs (e.g., bowel, rectum, bladder, urethra, ureters, vagina), seroma, 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., dysuria, urinary retention, incomplete emptying, straining, positional voiding, weak stream), de novo or worsening prolapse in untreated compartment, granulation tissue formation, palpable mesh (patient and/or partner), recurrent prolapse, sexual dysfunction, vaginal discharge (abnormal) and vaginal scarring, tightening, rigidity, shortening and/or contracture.
The occurrence of these events may require one or more revision surgeries, including removal of the mesh.
Complete removal of the mesh may not always be possible, and additional surgeries may not always fully correct the complications.
There may be unresolved pain with or without mesh 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 mesh is right for you.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Axis™ / Suspend® Brief Statement
Description – Axis Tutoplast® Processed Dermis and Suspend Tutoplast® Processed Fascia Lata are regulated as 361 human and cell tissue products and are restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional. This includes supplemental support and reinforcement of soft tissue, such as suburethral graft placement in stress urinary incontinence procedures, and support and reinforcement of fascial structures in the pelvic floor in pelvic organ prolapse procedures.
Warnings – The same medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. As with any human tissue implant, the potential for transmission of infectious agents may exist. A small number of patients may experience localized immunological reactions to the implant. Successful treatment is dependent upon the patient’s host tissue response. Resorption of the implant and commensurate substitution with functional host tissue is required to restore function.
Precautions – Prior to use, the surgeon must become familiar with the implant and the surgical procedure. Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for procedures using this implant., as such conditions may compromise outcomes. The implant should be used with caution in surgical sites where an active infection is present or in sites with poor perfusion. If the surgeon determined that the clinical circumstances require implantation in a site that is contaminated, or infected, appropriate local and/or systemic anti-infective measures should be taken. Appropriate placement and fixation of the implant are critical to success of the surgical procedure. The Suspend implant should be used with caution in sites where it is placed perpendicular to native tissue.
Tutoplast is a registered trademark of Tutogen Medical GmBH