Thousands of women have filed lawsuits after suffering the debilitating side effects produced by transvaginal mesh, a medical treatment designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
These women set out to treat their conditions, but in many cases ended up with problems much worse than the ones they hoped to remedy. Many of these women claim that they weren’t even warned that this conditions may develop.
What Is Transvaginal Mesh?
Transvaginal mesh is a type of surgical mesh used for urogynecologic procedures. The two most common procedures that use the prosthetic mesh are pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is designed to support weakened tissue in order to prevent further complications. There are two types of transvaginal mesh:
- Synthetic mesh – Found in knitted mesh or non-knitted sheet forms. Usually non-absorbable.
- Animal-derived mesh – Generally made of animal tissue, designed to absorb back into the body.
Non-absorbable mesh is designed to be a permanent implant, while absorbable mesh is designed to degrade, allowing the body to absorb it.
It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair. However, transvaginal mesh has injured thousands due to instances of migration, perforation and other complications.
What Are POP And SUI?
Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are two conditions that were transvaginal mesh in treatment. Many women who received the implant during treatment claim that they were not properly warned about the destructive side effects of the device. Only a doctor can diagnose and treat the following conditions:
Stress urinary incontinence (SUI) – Also known as stress urinary incontinence (SUI) or effort incontinence, SUI affects a person’s ability to control their their flow of urine, usually due to a weakened closure of the bladder. It is characterized by the loss of small amounts usually while coughing, laughing, sneezing, or exercising.
The urethra, the body part where urine flows, is supported by the fascia on the pelvic floor. When this support is weakened, the urethra can move downward during physical exertion, causing an escape of urine. Transvaginal mesh can be used to provide additional support to this system.
Pelvic organ prolapse (POP) – Pelvic organ prolapse (POP), or female genital prolapse, is characterized by the descent of female genital organs beyond their normal anatomical confines.
The main cause of the condition is when the pelvic floor collapses as a result of childbirth or heavy lifting which can tear soft tissues, i.e. herniating fascia membranes so that the vaginal wall collapses, resulting in cystocele, rectocele or both. Vaginal mesh is used to reinforce the damage caused by POP.
Though vaginal mesh was made to help patients, flaws in design and manufacturing have caused a host of complications for thousands of women. Each of these conditions comes with its own set of painful symptoms. If you or a loved one has experienced two or more of the following symptoms, contact your doctor immediately:
Stress urinary incontinence (SUI) may cause urine leakage while:
- Standing up
- Getting out of a car
- Lifting something heavy
- Having sexual intercourse
Pelvic organ prolapse symptoms include:
- Pressure or fullness in the pelvic area
- Lower back backache
- Pain during sex
- A feeling that something is falling out of the vagina
- Urinary problems such as leaking of urine or a chronic urge to urinate
- Spotting or bleeding from the vagina
Transvaginal Mesh Manufacturers
Transvaginal mesh is manufactured by numerous large medical companies. Some of these manufacturers have already settled the lawsuits against them, with patients receiving millions of dollars.
Some companies that have seen lawsuits filed against them for their faulty surgical mesh products include:
- American Medical Systems
- C.R. Bard
- Boston Scientific
- Cook Medical
These companies have also received communication from the FDA warning of the dangers of transvaginal mesh.
The FDA On Transvaginal Mesh
In January of 2016, The FDA issued a press announcement that detailed its intentions to reclassify transvaginal mesh “from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.”
The report went on to state the federal agency had seen a spike in reports of adverse events associated with the use of surgical mesh in transvaginal and POP repair. The article also addressed specific concerns by saying:
“The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.”
These warnings are being seen as “too little and too late” by many women who suffered painful, financially taxing side effects due after reparative surgeries. Transvaginal mesh is still being used in hospitals across America, despite acknowledgement of its dangers by The FDA.