Pinnacle^® Pelvic Floor Repair Kit - Posterior

Prescriptive Information

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Please refer to the Directions for Use provided with the product for complete instructions for use, contraindications, warnings and precautions.

WARNING
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

DEVICE DESCRIPTION
The Pinnacle Pelvic Floor Repair Kits are sterile, single use devices for transvaginal placement, consisting of (1) one Pinnacle Synthetic Mesh Assembly and (1) one Capio^® Suture Capturing Device. The mesh assembly is available in two configurations: Anterior/Apical and Posterior. The mesh assembly is a polypropylene knitted mesh with 2 or 4 integrated leg assemblies. The leg assemblies include a needle, lead, dilator and protective sleeve. The needle at the distal end of the leg assembly was designed to be placed into the needle carrier at the distal end of the Capio Suture Capturing Device. The leg assembly was designed to facilitate the passage of the Pinnacle Synthetic Mesh Assembly through bodily tissues for placement through the sacrospinous ligament and arcus tendineous fascia pelvis. For orientation purposes, the dilators are uniquely color coded. The white dilators identify the leg assemblies to be placed into the arcus tendinous and the blue dilators identify the leg assemblies to be placed into the sacrospinous ligament. Stripes are also present on the dilators on one side of the mesh assembly to differentiate each side (Left/Right). This Product Contains No Detectable Latex.

INDICATIONS FOR USE
The Pinnacle Pelvic Floor Repair Kits are indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor in vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

CONTRAINDICATIONS
The Pinnacle Synthetic Mesh is contraindicated for use in any patient in whom soft tissue implants are contraindicated. In addition patients with:

• Pathology of the soft tissue into which the Pinnacle Synthetic Mesh is to be placed.
• Pregnant patients, or patients that are considering future pregnancies.
• The potential of future growth (e.g. infants, children).
• Any pathology, including known or suspected uterine pathology, which would compromise implant placement.
• Any pathology that would limit blood supply and compromise healing.
• Blood coagulation disorder.
• Autoimmune connective tissue disease.
• Renal insufficiency and upper urinary tract obstruction.
• Pre-existing local or systemic infection. Treat the infection with the appropriate antiseptics and/or antibiotics to eliminate the infection before placing the Pinnacle Synthetic Mesh.

WARNINGS/POTENTIAL COMPLICATIONS

• Hysterectomy may be needed in the future; Use of mesh may make future hysterectomies more difficult due to tissue in-growth and scarring.
• Cervical length must be evaluated during the preoperative workup; Patients with cervical elongation may not be appropriate candidates for apical repair procedures; Cervical amputation may be considered for patients with cervical elongation who choose to undergo the procedure.
• Continued screening and surveillance for cervical and uterine disease may be required; Regular pelvic exam, Pap test and endometrial biopsies should be continued as medically indicated.
• Performing an apical repair for cases involving uterine enlargement, in the presence of benign disease, should be at the physician’s discretion; An enlarged uterus may compromise the effectiveness of the procedure in some cases.
• Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.
• Patients should be counseled to refrain from heavy lifting, exercise and intercourse for a minimum of six (6) weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.
• In the event that infection presents post procedure, the entire mesh may have to be removed or revised.
• Like all foreign bodies, the mesh may potentiate an existing infection reaction or sepsis.
• Tissue responses to the implant could include: local irritation at the wound site, vaginal erosion or exposure though the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation, foreign body reaction, and inflammation. The occurrence of these responses may require removal or revision of the mesh.
• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.
• Mild to moderate incontinence may occur due to incomplete support.
• Known risks of surgical procedures for the treatment of prolapse include pain, infection, erosion/exposure, device migration, complete failure of the procedure resulting in recurrent or de Novo prolapse and/or incontinence.
• Punctures or lacerations of vessels, nerves, bladder, urethra, or bowel may occur during placement and may require surgical repair.
• A digital rectal exam should be performed to detect possible rectal perforation.
• Cystoscopy is recommended to confirm bladder integrity or detect possible bladder or ureteral perforation.
• Overweight women may be prone to intraoperative and postoperative complications (weight parameters to be determined by the physician).

PRECAUTIONS

• Surgical treatment of female pelvic organ prolapse should be performed by clinicians with adequate training and experience.
• Training on the use of the Pinnacle^® Pelvic Floor Repair Kit is recommended and available. Contact your company sales representative to arrange for this training.
• The physician is advised to consult this DFU and the medical literature regarding techniques, complications and hazards associated with the intended procedures.
• Individual patient’s anatomy may vary greatly. For each procedure it is important that the intended planes for mesh placement and the intended location for mesh leg placement are planned and known for each individual patient. Employment of imaging methods before and after mesh placement may aid in proper mesh placement and confirm absence of injury to non-target anatomical structures.
• Standard surgical practices should be followed for pelvic floor procedures as well as for the management of contaminated or infected wounds.
• The procedure should be performed with care, using the Capio^® Suture Capturing Device provided with the kit, to avoid puncture or laceration of any vessels, nerves, bladder, urethra and bowel.
• Avoid excessive tension on the mesh during handling and positioning to prevent damage to the device.
• Do not remove the protective plastic sleeve covering mesh legs until proper position has been confirmed.
• Avoid excess tensioning of the mesh when positioning to avoid over correction of the defect.
• Take special care in cases of bladder prolapse because of anatomical distortion.
• Use only size 0 Capio Sutures with the Capio Suture Capturing Device.
• Do not affix mesh with any staples, clips, or clamps as mechanical damage to the mesh may occur.

ADVERSE EVENTS
Potential adverse reactions that may be associated with surgically implanted materials include:

• Abscess formation/Foreign body reaction;
• Adhesion formation;
• Allergic, hypersensitivity or other immune reaction;
• Bruising, hematoma, hemorrhage;
• Constipation;
• Dehiscence and/or necrosis;
• Dyspareunia;
• Erosion/extrusion;
• Fistula formation;
• Granulation tissue formation;
• Infection/Sepsis potentiation;
• Inflammation (acute or chronic);
• Mesh and/or tissue contracture;
• Organ perforation;
• Pain, discomfort, irritation;
• Post-operative bleeding;
• Recurrent prolapse;
• Surgical site wound irritation, erythema, edema;
• Ureteric injury;
• Ureter Obstruction;
• Urinary Incontinence;
• Urinary retention;
• Vaginal discharge;
• Vaginal shortening or stenosis;
• Vessel/Nerve injury/perforation;
• Wound dehiscence.