FDA gives a separate set of recommendations each for the surgeon
Modern day surgery uses the principles of placing surgical mesh inside the human body to achieve the desired results. The mesh works by the foreign body principle, inciting an inflammatory reaction and then forming a fibrotic barrier which is protective for the organs. Surgical mesh is used in many procedures like herniorrhaphy, stress incontinence surgery and pelvic organ prolapse repairs. However it should be noted that research has shown a few problems associated with the use of surgical mesh and so FDA has provided a guide in the use of these meshes.
The following is a summary of FDA’s recommendations regarding the use of surgical mesh implants
Recommendations for the surgeons: TheFDA gives a separate set of recommendations each for the surgeon and the patient. Following things are to be taken care of by the surgical end of the matter.
1.The surgeon should realize that most forms of pelvic organ prolapse can be treated conservatively or by simple repair without the need of a mesh. Therefore unnecessary usage of the transvaginal mesh should be minimized.
2. The mesh placement is a permanent approach, and once it has been placed it might be difficult to operate on the same patient in the future for any other problem. This is owing to the altered anatomy of the patient’s internal structures as a result of mesh implantation. It will predispose the women to greater risks in the future surgeries.
3.The risk of complications is higher with transvaginal placement of the mesh than the abdominal approach. Therefore an abdominal surgery should be opted in most cases, when there is no contraindication to it.
4.It is the surgeon’s responsibility that all the pros and cons should be told to the patient before the surgery. A complete informed consent should be sought before proceeding to the surgery.
Recommendations for the patients: The following is a set of guidelines is to be followed religiously by the patients in order to decrease the chances of complications.
1.It is mandatory for the patient to ask the surgeon everything about the mesh surgery. The patient needs to understand as to why the surgeon is opting for a mesh and what could go wrong if a non-mesh procedure is employed.
2.The women have to continue with the regular post operative routine check-ups. It is also mandatory to notify to the surgeon any kind of complications developing; e.g. continuous vaginal bleeding, heavy vaginal discharge, pain in the legs and lower abdomen, persistent fever and painful intercourse. This will allow for the prompt start of treatment of these issues.
3. Those patients who have had a pelvic organ prolapse surgery, but do not know if a mesh has been placed or not, should try to find this out on their next scheduled visit. This is important as it will help the patient recognize the possible side effects that can develop after the surgery and will aid in the early detection of these complications.