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
- Diabetes
- 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 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 mesh is right for you.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Minneapolis, MN
PM-07280 02/19/2019
