Mesh Implants have recently been a topic of controversy in the medical field. Several issues have been brought up by post-surgery patients who developed new problems following a mesh implantation.
Surgical mesh implants are indicated for patients whose pelvic floor muscles and ligaments have weakened causing the pelvic organs to sag downwards. This is true in patients with hernia and pelvic organ prolapse. This can be brought about by old age, multiple vaginal deliveries for women, chronic constipation, constant lifting of heavy objects and past abdominal surgeries among others.
Its, then, purpose is to embed a mesh into the pelvis which acts as a “lift” to hold abdominal organs in place and prevent them from sagging.
There are several ways do this. One operative procedure that is done to women, and is the subject of many debates and discussions, is the insertion of the mesh implant transvaginally.
TRANSVAGINAL PROLAPSE REPAIR
Transvaginal prolapse repair can be done by doing a small incision into the vaginal and inserting the sterile mesh and implanting in into the surrounding tissues of the abdomen. Most meshes are sold in kits that come with the sterile non-absorbent mesh and disposable surgical instruments.
The nightmare begins post-surgery. The severe complications that could arise following mesh implantation are severe chronic pain, sepsis, permanent nerve damage and erosion. These said complications can be debilitating and can have permanent damage.
Some other common but less life-threatening complications can be treated with antibiotics and estrogen cream applications. In some severe cases, a surgical removal of the synthetic mesh is necessary. Others need to undergo several more surgeries than two or three times. In worse cases of erosion, only partial removal of the mesh can be done because it has embedded deeply in the body tissues to be removed safely.
FDA FURTHERS INVESTIGATION
The Federal Drug Administration has received many complaints and allegations on urogynecological surgical mesh implants over the years. Many post-operative patients showed complications that were linked to the mesh implant and investigations have been done regarding this matter. Upon analysis, FDA has found out that in 212,113 transvaginal prolapse repair patients, those who underwent a mesh implantation were likely to have repeat surgery 2.26 times more than those who didn’t.
As of now surgical mesh is placed in the Class II (Moderate Risk) Categorization. However, the FDA is considering whether to reclassify it in the Class III Category. This categorisation is ideally based on the FDA standards of safety and effectiveness of medical devices.