Defective Transvaginal Mesh Implants
Pain and Suffering is a Way of Life for Transvaginal Mesh Victims.
Video: The following video describes the brands and symptoms associated with having a vaginal mesh implant including American Medical Systems, Bard and Johnson & Johnson. Bleeding, urinary problems, roughness in the vagina and severe pain and weakness are just some of the effects women have suffered.
If you've ever questioned "what is pain and suffering" in legal terms, thousands of women can tell you. The stories of of women who received a transvaginal mesh implant almost always begin the same way.
The women were suffering from pelvic organ prolapse and/or stress urinary incontinence, both conditions that millions of women commonly face after childbirth or as they age. So, they approached their doctor who suggested that they go in for surgery - a "minimally invasive" procedure that would involve inserting a synthetic mesh device into the vagina.
The mesh implants were supposed to free these women from the intimate discomforts they faced as the result of the pelvic organs bulged into the vagina.
Once implanted, these hammock-like mesh implants were meant to bolster the pelvic tissues and help keep sagging organs in place.
Severe Complications after Surgery
But, for tens of thousands of women who underwent this procedure, something went terribly wrong. Rather than fix these women's problems, the mesh implants led to a number of terrible complications. Most women found that the mesh device eroded through the vaginal lining, causing infections, nerve damage and excruciating pain. Many said they were unable to sit or lie down. Some women were not able to urinate without a catheter. Others had to be hospitalized multiple times. Most women said that their sex lives had become nonexistent.
According to the U.S. Food and Drug Administration, there were approximately 100,000 women who underwent these pelvic organ prolapse repairs using surgical mesh in 2010. About 75,000 of those were transvaginal procedures.
In addition, the agency estimates that 260,000 women underwent surgery for female stress urinary incontinence with a majority of them, about 206,000, getting a surgical mesh sling placed under the urethra. A majority of these mesh implants are made of non-absorbable synthetic polypropylene.
Procedure Made Symptoms Worse
A recent article in Lawyers and Settlements gives the example of a woman who has filed a lawsuit against American Medical Systems. The Los Angeles woman says six weeks after being implanted with the mesh, it became too painful. She and her husband have not had sex for more than a year and he wants to leave her, the lawsuit claims. Like many other women who underwent this surgery, she said her urinary incontinence problems became worse after the procedure. Not being intimate with her husband also caused both of them significant stress, anxiety and depression, she said.
On March 22, PBS interviewed Linda Gross, the woman who was awarded more than $11 million by a New Jersey jury after she suffered most of the above-mentioned complications. In her PBS interview, Gross says she tried unsuccessfully to get the defectively designed mesh out of her body. She says removing the mesh implant was like pulling bubble gum out of her hair. Even after 22 harrowing surgeries, doctors have been unable to remove parts of the mesh that are still sticking to tissue.
Flawed FDA Approval Process
Gross sued Ethicon, a unit of Johnson & Johnson, which manufactured the Gynecare mesh with which she was implanted. There are many other manufacturers who make these mesh implants including C.R. Bard and American Medical Systems. Safety advocates and medical experts say that the vaginal mesh fiasco is evidence of how the federal regulatory agency, the U.S. Food and Drug Administration (FDA) fails to protect consumers. In the PBS special, Dr. Greg Curfman, executive editor of the New England Journal of Medicine, says many of these complex medical devices are failing and causing serious complications because they have been put in the market without proper clinical testing.
Transvaginal mesh products were approved under Section 510(k) of the Food, Drug and Cosmetic Act, where a medical device manufacturer is required to notify the FDA of its intent to market a new device at least 90 days before its release. If the new device is "substantially equivalent" to a device that is currently in the market, it is known as a predicate. Human or clinical testing is not required under the law for such products. This loophole or lack of safeguards in the approval process has resulted in the approval of medical devices that should not have been out in the marketplace such as transvaginal mesh. This has caused serious and life-changing complications for thousands of women.
Understanding Your Rights
Knowing what we know about these products today, the takeaway for women here is that patients should be their own most aggressive advocates. If you are considering this procedure, please discuss the details with your doctor. Understand the risks involved. If possible talk to someone who has undergone this procedure to see how your life may change. Have an open discussion with a physician that understands the pros and cons of a transvaginal mesh. One that will weigh the benefits against the risks and not pressure you into a procedure that could change your life for the worse.
Thousands of women have sought out legal advise to determine their right to recovery for pain and suffering. Some of the symptoms of a transvaginal mesh can last a lifetime. If you have experienced severe complications or continue to suffer the adverse effects of vaginal mesh implants, please contact an experienced California product liability lawyer who is currently handling cases similar to yours.
Injured victims in such cases can seek compensation for damages including all medical expenses, cost of surgeries, loss of wages, loss of livelihood, loss of consortium, pain and suffering and emotional distress. There is absolutely no excuse for exposing consumers to products that are dangerous, defective and most importantly, untested.