Surgical Mesh Injuries: Why Haven’t Products Been Recalled?

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Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Jul 16, 2021

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Surgical mesh injuries from products such as the Bard Avaulta surgical mesh system can be life altering; yet, these products still haven’t been recalled by the FDA or by manufacturers. Should they be?

Bard Avaulta Injuries: SUI & POP

Surgical mesh products made by manufacturers like C.R. Bard are supposed to provide long-lasting organ stabilization for the fascial structures of the pelvic floor. In layman’s terms, the product is designed to hold organs in place. The Bard Avaulta system has knit arms that are supposed to provide tension-free fixation of the implant – meaning it should hold in place without tension.

The implants are made of a synthetic mesh which is designed to allow the vaginal tissue to infiltrate it or grow into it. However, if you get an eroded or infected mesh implant in place, it becomes difficult to remove because it is designed to allow tissue to grow into it. So, if the mesh implants have to be taken out because they are defective, you face multiple surgeries, scarring of the pelvic tissue, and disfigurement.

Unfortunately, many women who have been implanted with this product suffer from side effects known as stress urinary incontinence (SUI) and pelvic organ prolapse (POP) caused by the Bard Avaulta and other surgical mesh products.

  • Stress Urinary Incontinence (SUI). Stress urinary incontinence is a condition where a woman loses urine during physical activities that increase abdominal pressure – which sometimes can occur due to something as simple as a sneeze, cough or laugh. Those activities can increase pressure in the bladder, which is basically a sort of balloon that is filled with liquid that rising pressure can push out through the urethra. When the urethra has been weakened, stress urinary incontinence can be intensified. Ironically, the mesh can weaken the urethra when providing support to the pelvic floor is the primary is its primary purpose.
  • Pelvic Organ Prolapse (POP). Pelvic organ prolapse is a condition that also occurs when the normal support for the vagina is lost. It is basically a sagging or dropping of the bladder, the urethra, the cervix and the rectum. In extreme cases, these can come out. As the prolapse progresses,women can feel bulging tissue protruding through the opening of the vagina. It is a very serious condition which can worsen over time and may require surgery.

There are different types of pelvic organ prolapse and some women will develop vaginal prolapse which usually happens after menopause or multiple childbirths or just even a single childbirth or a hysterectomy. You can also lose pelvic support when any part of the pelvic floor is injured again during childbirth or surgery. Sometimes back or pelvic fractures from falls will cause it to happen or even being involved in a motor vehicle accident. Other conditions that can promote prolapse can include constipation, chronic straining, smoking, chronic coughing or heavy lifting. Bard Avaulta injury lawyers say that in order to address those conditions, many women will have to undergo transvaginal placement of surgical mesh devices to correct and restore weakened vaginal muscles. Those procedures often lead to surgical mesh lawsuits.

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