1. Franklin RR, Trout R, Marks MG, et al. Interceed barrier in the prevention of post-operative adhesions following laparotomy: meta-analysis of its efficacy and safety. Poster Presentation: 1995 ASRM.

2. Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J. 2008;19(8):1043-1047.

3. GYNECARE TVT ABBREVO™ Continence System Instructions for Use. Somerville, NJ: Ethicon, Inc 2015.

4. Fixation Cadaver Study, 2010.

5. ARTISYN^® Instructions for Use. Somerville, NJ: Ethicon, Inc. 2015

6. Amarasinghe C. Surgeon design validation completion report. ARTISYN™ Y-Shaped Mesh. DVCR0000031 version A. June 20, 2012

7. Ten Broek RPG, Stommel MWJ, Strik C, et al. Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis. The Lancet 2014;383(9911):48-59.

8. Ahmad G, Duy JMN, Farquhar C, et al v. Cochrane Database Syst Rev 2008;(2);1-40.

9. Wiseman DM, Trout JR, Franklin RR, Diamond MP. Meta-analysis of the safety and efficacy of an adhesion barrier (INTERCEED) in Laparotomy. J Repro Med. 1999;44: 325-331.

10. Sawada T, Nishizawa H, Nishio E, Kadowaki M. Postoperative adhesion prevention with an oxidized regenerated cellulose adhesion barrier in infertile women. J Reprod Med. 2000;45:387-389.

11. diZerega GS. Peritoneum, Peritoneal Healing, and Adhesion Formation. Peritoneal Surgery. New York, NY: SpringerVerlag; 2000:27-33

12. GYNECARE INTERCEED^® Absorbable Adhesion Barrier. Instructions for Use. Ethicon Inc. 

GYNECARE INTERCEED^® ABSORBABLE ADHESION BARRIER 

Essential Product Information

INDICATIONS:

GYNECARE INTERCEED^® Absorbable Adhesion Barrier is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles.

CONTRAINDICATIONS:

The use of GYNECARE INTERCEED^®> (TC7) Absorbable Adhesion Barrier is contraindicated in the presence of frank infection. GYNECARE INTERCEED^® is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.

WARNINGS:

The safety and effectiveness of GYNECARE INTERCEED^® in laparoscopic surgery or any procedures other than open (laparotomy) gynecologic microsurgical procedures have not been established.

Postoperative adhesions may be induced by GYNECARE INTERCEED^® application if adjacent tissues (eg, ovary and tube) and structures are coapted or conjoined by the device, or if GYNECARE INTERCEED^® is folded, wadded or layered. Postoperative adhesions may occur in the presence of GYNECARE INTERCEED^® if meticulous hemostasis is not achieved prior to application. As with all foreign substances, GYNECARE INTERCEED^® should not be placed in a contaminated surgical site.

PRECAUTIONS:

Use only a single layer of GYNECARE INTERCEED^®, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of GYNECARE INTERCEED^®. Care should be exercised in applying GYNECARE INTERCEED^® to a pelvic organ not to constrict or restrict it. If the product comes in contact with blood prior to completing the procedure, it should be discarded, as fibrin deposition cannot be removed by irrigation and may promote adhesions formation. Ectopic pregnancies have been associated with fertility surgery of the female reproductive tract. No data exist to establish the effect, if any, of GYNECARE INTERCEED^® on the occurrence of ectopic pregnancies. No adequate studies have been conducted in women who have become pregnant within the first month after exposure to GYNECARE INTERCEED^®. No teratogenic studies have been performed. Therefore, avoidance of conception should be considered during the first complete menstrual cycle after use of GYNECARE INTERCEED^®. The safety and effectiveness of using GYNECARE INTERCEED^® in combination with other adhesion prevention treatments have not been clinically established. GYNECARE INTERCEED^® is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNECARE INTERCEED^® must not be resterilized. Foreign body reactions may occur in some patients. Interactions may occur between GYNECARE INTERCEED^® and some drugs used at the surgical site. Pathologists examining sites of GYNECARE INTERCEED^® placement should be made aware of its usage and of the normal cellular response to GYNECARE INTERCEED^® ‘to facilitate proper evaluation of specimens'.

ADVERSE REACTIONS:

The type and frequency of adverse events reported are consistent with events typically seen following surgery. Postsurgical adhesions may occur in the presence of GYNECARE INTERCEED^®. For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse
 

GYNECARE TVT™ FAMILY OF PRODUCTS
ESSENTIAL PRODUCT INFORMATION
INDICATIONS
The GYNECARE TVT™ Tension-free Support for Incontinence, GYNECARE TVT EXACT^® Continence System and GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence, are intended to be used in women as pubourethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
GYNECARE TVT™ Obturator System Tension-free Support for Incontinence and GYNECARE TVT ABBREVO^® Continence System are intended to be used in women as sub-urethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
 
CONTRAINDICATIONS

As with any suspension surgery, these procedures should not be performed in pregnant patients.
Additionally, because the PROLENE Polypropylene Mesh will not stretch significantly, it should not be performed in patients with future growth potential including women with plans for future pregnancy.
WARNINGS & PRECAUTIONS

Do not use the GYNECARE TVT Family of Products in patients who are on anti-coagulation therapy.
Do not use the GYNECARE TVT Family of Products in patients who have a urinary tract infection.
Bleeding or infection may occur post-operatively.
Transient leg pain lasting 24-48 hours may occur and can usually be managed with mild analgesics after a GYNECARE TVT Obturator System or GYNECARE TVT ABBREVO System procedure.
Since no clinical information is available about pregnancy following sub-urethral sling procedure with the GYNECARE TVT Family of Products, the patient should be counseled that future pregnancy may negate the effects of the surgical procedure and the patient may again become incontinent.
Since no clinical information is available about vaginal delivery following sub-urethral sling procedure with the GYNECARE TVT Family of Products, in case of pregnancy, delivery via cesarean section should be considered.
Post-operatively, refrain from heavy lifting and/or exercise (e.g. cycling, jogging) for at least three to four weeks and to refrain from intercourse for one month.  The patients can usually return to other normal activity after one or two weeks.
Contact your surgeon immediately if there is burning sensation during urination, unusual bleeding, problems voiding or other problems.
 
PATIENT FACTORS
Physicians should use their surgical experience and judgment to determine if PROLENE Mesh is appropriate for certain patients.  Patient-specific factors may impair wound healing, which may increase the likelihood of adverse reactions.
 

ADVERSE REACTIONS

Punctures or lacerations or injury of vessels, nerves, structures or organs, including the bladder, urethra, or bowel, may occur and may require surgical repair.
Improper placement of the GYNECARE TVT Family of Products devices may result in incomplete or no relief from urinary incontinence or may cause temporary or permanent urinary tract obstruction.
Transitory local irritation at the wound site may occur.  
As with any implant, a foreign body response may occur.  This response could result in extrusion, erosion, exposure, fistula formation and/or inflammation. 
Mesh extrusion, exposure, or erosion into the vagina or other structures or organs.
As with all surgical procedures, there is a risk of infection.  As with all foreign bodies, PROLENE Mesh may potentiate an existing infection.
Acute and/or chronic pain.
Voiding dysfunction.
Pain with intercourse which, in some patients may not resolve. 
Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur.
Recurrence of incontinence.
Bleeding including hemorrhage or hematoma. 
One or more revision surgeries may be necessary to treat these adverse reactions.
PROLENE Mesh is a permanent implant that integrates into the tissue. In cases in which the PROLENE Mesh needs to be removed in part or whole, significant dissection may be required.
OTHER ADVERSE REACTIONS

Seroma
Urge incontinence
Urinary frequency
Urinary retention
Adhesion formation
Atypical vaginal discharge
Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
Death
 
Consult your doctor to discuss the potential benefits and risks of your treatment options and whether PROLENE mesh is appropriate for you.
026356-180221
 

ARTISYN™ Y-Shaped Mesh
ESSENTIAL PRODUCT INFORMATION
 
INDICATIONS
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.
 
CONTRAINDICATIONS

ARTISYN™ Y-Shaped Mesh should not be used in infants, children, pregnant women, or in women planning future pregnancies, because the mesh will not stretch significantly as the patient grows.
ARTISYN™ Y-Shaped Mesh should not be used in the presence of active or latent infections or cancers of the vagina, cervix, or uterus.
ARTISYN™ Y-Shaped Mesh must always be separated from the abdominal cavity by peritoneum. 
ARTISYN™ Y-Shaped Mesh must not be used following planned intraoperative or accidental opening of the gastrointestinal tract. Use in these cases may result in contamination of the mesh, which could lead to infection that may require removal of the mesh.
 
WARNINGS

Patients who are on anticoagulation agents and undergoing surgery using ARTISYN™ Y-Shaped Mesh must have their anticoagulation therapy carefully managed.
A digital rectal examination may be performed to detect possible rectal perforation.
Cystoscopy may be performed to confirm bladder integrity or to detect possible bladder or ureteral perforation.
Postoperatively, the patient should be advised to refrain from intercourse, heavy lifting, and/or exercise (e.g., cycling, jogging) until the physician determines when it is suitable for the patient to return to her normal activities.
Use ARTISYN™ Y-Shaped Mesh with care, and with attention to patient anatomy and to proper dissection technique, to avoid damage to vessels, nerves, bladder, bowel, and vaginal wall.
The safety and effectiveness of this product has not been validated inclinical trials.
Reuse of this device (or portions of this device) may create a risk of productdegradation and cross-contamination, which may lead to infection ortransmission of bloodborne pathogens to patients and users. 
PRECAUTIONS

 Users should be familiar with surgical procedures and techniques involving pelvic floor repair and synthetic meshes before employing ARTISYN™ Y-Shaped Mesh.
 Avoid placing excessive tension on the mesh implant during placement.
 This product should only be used under the prescription of a licensed healthcare practitioner.
 In patients with compromised immune systems or other conditions that could compromise healing, the risks and benefits should be weighed carefully.
 Vaginal or urinary tract infection should be treated and alleviated prior to implantation.
 
ADVERSE REACTIONS
Potential adverse reactions are those typically associated with surgery employing implantable materials of this type, bleeding including hemorrhage or hematoma, urinary incontinence, urge incontinence, urinary frequency, urinary retention or obstruction, voiding dysfunction, acute  and/or chronic pain, wound dehiscence, nerve damage, recurrent prolapse, inflammation, adhesion formation, fistula formation, contracture, scarring and mesh extrusion, exposure, or erosion into the vagina or other structures or organs.
As with any implant, a foreign body response may occur.  This response could result in extrusion, erosion, exposure, fistula formation and/or inflammation. 
Potential adverse reactions are those typically associated with pelvic organ prolapse repair procedures, including pelvic pain or pain with intercourse, which in some patients may not resolve
Dissection for pelvic floor repair procedures has the potential to impair normal voiding for a variable length of time.
Excessive contraction or shrinkage of the tissue surrounding the mesh, vaginal scarring, tightening and/or shortening may occur.
As with all surgical procedures, there is a risk of infection.  As with all foreign bodies, ARTISYN™ Y-Shaped Mesh may potentiate infection.
Punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel, may occur and may require surgical repair.
Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur
These adverse reactions may require surgical treatment.
 As with any surgery, one or more revision surgeries may be necessary to treat these complications.
ARTISYN™ Y-Shaped Mesh is a permanent implant that integrates into the tissue. In cases in which the ARTISYN™ Y-Shaped Mesh needs to be removed in part or whole, significant dissection may be required.

OTHER ADVERSE REACTIONS

Seroma
Adhesion formation
Atypical vaginal discharge
Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
Death
 
Consult your doctor to discuss the potential benefits and risks of your treatment options and whether ARTISYN™ Y-Shaped Mesh is appropriate for you.

087453-180206

Important Safety Information
 
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for Sacrocolposuspension/sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.
 
All surgical procedures present risks.  Complications associated with this procedure include those typically associated with surgery employing permanent synthetic implantable materials of this type, including hematoma, urinary incontinence, urinary retention or obstruction, voiding dysfunction, pain, infection potentiation, wound dehiscence, nerve damage, recurrent prolapse, inflammation, adhesion formation, fistula formation, contracture, scarring, and mesh exposure, erosion, or extrusion through vaginal epithelium. Potential risks or reactions are those typically associated with pelvic organ prolapse repair procedures, including pelvic pain or pain with intercourse.  These may resolve with time. Dissection for pelvic floor repair procedures has the potential to impair normal voiding for a variable length of time.  
 
Therefore, you should carefully discuss with your doctor and understand the benefits and risks of mesh Implant surgery before deciding how to treat your condition.   Speak with your physician regarding his/her experience with this procedure, and the anticipated probability of any of these complications.
 
 
ETHICON GYNECARE is dedicated to improving women’s quality of life by providing innovative solution for treating common pelvic health solutions.
 
Learn more:  To speak with a nurse call 1-888-GYNECARE (1-888-496-3227)
www.PelvicHealthSolutions.com

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.