Surgical procedures are generally very intimate and personal, some more than others. A transvaginal mesh is one of those procedures. Thousands of women face the decision to have one put in their bodies every year. It not only gives women a much more comfortable quality of life, but could also save their lives.
However, certain lines of this medical device have been found to cause more problems than helped. You see, it is a device that is meant to replace a natural function in the body that keeps the organs in place and helps a woman’s internal organs functioning normally.
It is essentially a “surgical net” made out of prolene, a synthetic monfilament nonabsorbable polypropylene suture that is a finely constructed synthetic mesh that us generally used for skin closure. It is intended to hold up the bladder and uterus to avoid discomfort and urinary problems.
The need for a transvaginal mesh arises when the muscles within the vaginal cavity that hold up the bladder and uterus weaken to the point that they can no longer adequately support the organs, thus causing them to sag, putting significant pressure on the area restricting the passing of urine and other complications such as pelvic organ prolapse and stress urinary incontinence.
Installing a transvaginal mesh is a 20-minute outpatient procedure that is considered not invasive. But reversing the procedure is far more involved and could involve a more significant procedure depending on the seriousness of the ailment that caused with need for the removal of the device.
Problems Associated with Transvaginal Mesh
Since the medical device was introduced in 1996, it seems to have been going through a bumpy road of testing. Perhaps because much of this testing is human testing. Though in theory the concept behind transvaginal meshs seems sound, the reality is that they are far from fully developed and in some cases have been found to be highly detrimental to the patient. This is because they can cause some serious ailments.
Transvaginal mesh problems:
Erosion – This is exactly what it sounds like, the actual depletion in the strength or integrity of the materials that allow the mesh to keep the organs in place. When this happens, the material must be adequately removed before a new mesh is put back in.
Infection – This is probably one of the worst consequences of the device. The mesh cuts into the flesh of the organs and the open wounds get infected. This is different from the normal bladder infection, which is located inside the organ. An internal infection could result in hospitalization, could spread to other organs, or could result in death of the patient.
Granuloma – This is a build up of cells around the mesh that could result in calcium deposits around the organs where the mesh touches them. This has a chance of forming into an infection and may cause complications when removing the device.
Incomplete voiding – This refers to the draining of urine from the bladder. Incomplete voiding causes patients to go frequently and could result in painful bladder infections if the buildup is too great or too long.
Pain – This could be associated with many factors such as the improper installation of the device, slippage, the improper placement of the device, infection, and internal personal injuries caused by the mesh.
Intraoperative Injuries – These are injuries that happen to internal organs that may require surgery to fix. When related to a transvaginal mesh, they can happen to various organs including the bladder, gastrointestinal tract, or uterus.
Transvaginal Mesh Research
The Food and Drug Administration (FDA) says that they have been aware of the problems with transvaginal meshs of various brands since 2006. They have received thousands of complaints about some of the most defective devices, from those that are badly designed to those that plainly don’t work but were sold anyway.
An example of sheer ineffectiveness was the transvaginal mesh offered by Boston Scientific, who ended up pulling their product for the market under pressure from the FDA. Of course there were other companies right there to pick up where Boston Scientific left off. With this the FDA has given some warnings and guidelines for the installation, use, and replacement of the devices.
Recommendation regarding transvaginal meshs:
Educate – Familiarize yourself with the different types products and procedures.
Awareness – Just by reading this article you are more informed than many transvaginal mesh patients. Make sure you ask lots of questions and know everything about your product and procedure.
Reactions – Be aware of the health issues that arise from the device, because they could feel unrelated to your device when in fact they are being caused by the device.
Document – Request product specific information and literature including the serial number of the specific unit. Try to get the actual package it came in and keep a photocopy of label specifics.
Removal – Prior to removal make sure you get a second opinion and a complete explanation of the reasons and procedure. Also, make sure there you ask about any findings post procedure.
Defective Medical Device Lawyers
Defective medical devices can seriously effect a woman’s health and could possibly do permanent damage to vital internal organs. This could result in extensive hospitalization and a series of surgeries that may not have been required is the device had been properly designed and tested.
The defective design legal team at Phillips Law Firm has been following this issue since it was brought to the attention of the public nearly six years ago. Since then we have been prepared to answer questions listen to the stories of real people affected by defective fentanyl patches. Call the Defective Device Attorneys at Phillips Law Firm for a consultation on how you can get the justice and compensation you deserve.