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Recommendations for Health Care Providers Treating Pelvic Organ Prolapse
The FDA recommends the following to health care providers using surgical mesh to treat pelvic organ prolapse (POP):
Training
Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
Patient Selection
Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
Consider these factors before placing surgical mesh:Recognize that in most cases, POP can be treated successfully without mesh.
Surgical mesh is a permanent implant that may make future surgical repair more challenging.
Having a mesh surgery may put the patient at risk for requiring additional surgery or for the development of new complications.Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
Informing your Patient
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse FOR HER PARTNER, scarring, and narrowing of the vaginal wall in POP repair.
Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.
Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.
Follow-up with your patient
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Recommendations for Women with Pelvic Organ Prolapse
It is important that women are aware of the risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP). Women who have mesh surgery may be at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.
If you are considering surgery with the use of surgical mesh to repair your POP, ask your surgeon these questions before you agree to the procedure:
Are you planning to use mesh in my surgery?
Why do you think I am a good candidate for surgical mesh?
Why is surgical mesh being chosen for my repair?
What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
What can I expect to feel after surgery and for how long?
Which specific side effects should I report to you after the surgery?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
What if the mesh surgery doesn’t correct my problem?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
If you have surgery with mesh to repair your POP, you should:
Continue with your 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 complications or symptoms.
Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.
Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
Talk to your health care provider about any questions you may have.
If you have had POP surgery but do not know whether their surgeon used mesh, ask your health care provider at your next scheduled visit.
Dr. Michael Hulse Ob gyn Canton Ga. Falany and Hulse avoid
Recommendations for Health Care Providers Treating Pelvic Organ Prolapse
The FDA recommends the following to health care providers using surgical mesh to treat pelvic organ prolapse (POP):
Training
Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
Patient Selection
Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
Consider these factors before placing surgical mesh:Recognize that in most cases, POP can be treated successfully without mesh.
Surgical mesh is a permanent implant that may make future surgical repair more challenging.
Having a mesh surgery may put the patient at risk for requiring additional surgery or for the development of new complications.Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
Informing your Patient
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse FOR HER PARTNER, scarring, and narrowing of the vaginal wall in POP repair.
Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.
Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.
Follow-up with your patient
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Recommendations for Women with Pelvic Organ Prolapse
It is important that women are aware of the risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP). Women who have mesh surgery may be at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.
If you are considering surgery with the use of surgical mesh to repair your POP, ask your surgeon these questions before you agree to the procedure:
Are you planning to use mesh in my surgery?
Why do you think I am a good candidate for surgical mesh?
Why is surgical mesh being chosen for my repair?
What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
What can I expect to feel after surgery and for how long?
Which specific side effects should I report to you after the surgery?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
What if the mesh surgery doesn’t correct my problem?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
If you have surgery with mesh to repair your POP, you should:
Continue with your 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 complications or symptoms.
Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.
Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
Talk to your health care provider about any questions you may have.
If you have had POP surgery but do not know whether their surgeon used mesh, ask your health care provider at your next scheduled visit.
Dr. Michael Hulse Ob gyn Canton Ga. Falany and Hulse avoid