On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016.
Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness. The companies will have 10 days to submit their plans to withdraw these products from the market.
Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms.
Contraindications of Tension-free Vaginal Tape and Transobturator Tape
As with any suspension surgery, these sling 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 and Precautions
• Do not use TVT or TOT procedure for patients who are on anticoagulation therapy.
• Do not use TVT or TOT procedure for patients who have a urinary tract infection.
• Users should be familiar with the surgical technique for bladder neck suspensions and should be adequately trained in the TVT or TOT implantation procedure before employing these devices. It is important to recognize that TVT or TOT is different from a traditional sling procedure in that the tape should be located without tension under the mid urethra.
• Acceptable surgical practice should be followed for the TVT or TOT procedure as well as for the management of contaminated or infected wounds.
• The TVT or TOT procedure should be performed with care to avoid large vessels, nerves, bladder, and bowel. Attention to local anatomy and proper passage of needles will minimize risks, especially in TVT.
• Retropubic bleeding may occur postoperatively. Observe for any symptoms or signs before releasing the patient from the hospital.
• Cystoscopy should be performed to confirm bladder integrity or recognize a bladder perforation.
• Do not remove the plastic sheath until the tape has been properly positioned.
• Ensure that the tape is placed with minimal tension under the mid urethra.
• Prolene mesh in contaminated areas should be used with the understanding that subsequent infection may require removal of the material.
• The patient should be counseled that future pregnancies may negate the effects of the surgical procedure and the patient may again become incontinent.
• Since no clinical experience is available with vaginal delivery following the TVT or TOT procedure, in case of pregnancy delivery via cesarean section is recommended.
• Postoperatively the patient is recommended to refrain from heavy lifting and/or exercise (i.e. cycling, jogging) for at least three to four weeks and intercourse for one month. The patient can return to other normal activity after one or two weeks.
• Should dysuria, bleeding or other problems occur, the patient is instructed to contact the surgeon immediately?
• All surgical instruments are subject to wear and damage under normal use. Before use, the instrument should be visually inspected. Defective instruments or instruments that appear to be corroded should not be used and should be discarded.
• As with other incontinence procedures, de novo detrusor instability may occur following the TVT procedure. To minimize this risk, make sure to place the tape tension- free in the mid-urethral position.
• Punctures or lacerations of vessels, nerves, bladder, or bowel may occur during needle passage and may require surgical repair.
• Transitory local irritation at the wound site and a transitory foreign body response may occur. This response could result in extrusion, erosion, fistula formation, and inflammation.
• As with all foreign bodies, prolene mesh may potentiate an existing infection. The plastic sheath initially covering the prolene mesh is designed to minimize the risk of contamination.
• Overcorrection, i.e. too much tension applied to the tape, may cause temporary or permanent lower urinary tract obstruction.
Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness. The companies will have 10 days to submit their plans to withdraw these products from the market.
Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms.
Contraindications of Tension-free Vaginal Tape and Transobturator Tape
As with any suspension surgery, these sling 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 and Precautions
• Do not use TVT or TOT procedure for patients who are on anticoagulation therapy.
• Do not use TVT or TOT procedure for patients who have a urinary tract infection.
• Users should be familiar with the surgical technique for bladder neck suspensions and should be adequately trained in the TVT or TOT implantation procedure before employing these devices. It is important to recognize that TVT or TOT is different from a traditional sling procedure in that the tape should be located without tension under the mid urethra.
• Acceptable surgical practice should be followed for the TVT or TOT procedure as well as for the management of contaminated or infected wounds.
• The TVT or TOT procedure should be performed with care to avoid large vessels, nerves, bladder, and bowel. Attention to local anatomy and proper passage of needles will minimize risks, especially in TVT.
• Retropubic bleeding may occur postoperatively. Observe for any symptoms or signs before releasing the patient from the hospital.
• Cystoscopy should be performed to confirm bladder integrity or recognize a bladder perforation.
• Do not remove the plastic sheath until the tape has been properly positioned.
• Ensure that the tape is placed with minimal tension under the mid urethra.
• Prolene mesh in contaminated areas should be used with the understanding that subsequent infection may require removal of the material.
• The patient should be counseled that future pregnancies may negate the effects of the surgical procedure and the patient may again become incontinent.
• Since no clinical experience is available with vaginal delivery following the TVT or TOT procedure, in case of pregnancy delivery via cesarean section is recommended.
• Postoperatively the patient is recommended to refrain from heavy lifting and/or exercise (i.e. cycling, jogging) for at least three to four weeks and intercourse for one month. The patient can return to other normal activity after one or two weeks.
• Should dysuria, bleeding or other problems occur, the patient is instructed to contact the surgeon immediately?
• All surgical instruments are subject to wear and damage under normal use. Before use, the instrument should be visually inspected. Defective instruments or instruments that appear to be corroded should not be used and should be discarded.
• As with other incontinence procedures, de novo detrusor instability may occur following the TVT procedure. To minimize this risk, make sure to place the tape tension- free in the mid-urethral position.
• Punctures or lacerations of vessels, nerves, bladder, or bowel may occur during needle passage and may require surgical repair.
• Transitory local irritation at the wound site and a transitory foreign body response may occur. This response could result in extrusion, erosion, fistula formation, and inflammation.
• As with all foreign bodies, prolene mesh may potentiate an existing infection. The plastic sheath initially covering the prolene mesh is designed to minimize the risk of contamination.
• Overcorrection, i.e. too much tension applied to the tape, may cause temporary or permanent lower urinary tract obstruction.
