Pelvic Organ Prolapse

Pelvic organ prolapse, often referred to as POP, is a serious women’s health issue that was rarely acknowledged or treated until recently. This medical condition occurs when the pelvic organs begin to weaken or loosen, causing rectal, bladder or uterine tissue to sag into the vagina. POP often occurs following menopause, the birth of a baby, or a surgery, such as a hysterectomy. The condition is not only painful, but it can often be embarrassing due to other associated symptoms, such as difficult sexual intercourse, urine leakage, lower back pain, and organs or tissue visibly hanging from the vagina.

Types of POP

Pelvic organ prolapse can impact different areas of the vagina.

The different forms of POP are:

• Cystocele – the bladder protrudes into the vagina’s front wall.
• Urethrocele – the urethra pushes against the vagina’s front wall.
• Uterine prolapse – The uterus sinks down into the vaginal area.
• Rectocele – a section of the rectum sags into the vagina’s back wall. Retocele can make it difficult for women to defecate.

Treatment for POP

Nowadays, doctors routinely screen women for symptoms and discuss ways to treat this condition. Many times, synthetic transvaginal mesh implants are used to treat POP and stress urinary incontinence (SUI), a condition in which people can no longer contain their urine.

Prior to the introduction of implants in 2000, doctors performed a procedure in which a surgeon stitched a woman’s pelvic muscles and ligaments back into their correct positions. Corrective surgeries and mesh implants have become so commonplace that approximately 10 percent of women, by the time they turn 80, will have surgery to correct issues related to this condition.

When surgery is not an option, doctors may suggest a pessary, a device that helps support a woman’s vaginal walls. The pessary can be made of rubber, plastic or silicone material, which a woman can insert and remove on her own. Pessaries are most successful in women who have milder cases of pelvic organ prolapse.

Problems with transvaginal mesh implants

The U.S. Food and Drug Administration (FDA) has not given mesh implants its full support, noting it has not concluded that implants are more effective than the surgeries that were performed before they were available on the market. The FDA has warned the public that those who receive implants may suffer from infection or inflammation and there is a possibility that the mesh may deteriorate inside a woman.

Despite the potential complications, the agency has not recalled any of the numerous mesh implants available on the market. However, the agency ordered manufacturers in January 2012 to perform clinical trials to evaluate the potential medical complications associated with their vaginal implants.

Lawsuits related to mesh implants

More than 30,000 vaginal mesh lawsuits have been filed in state and federal courts following reports that women suffered serious complications after receiving implants to treat pelvic organ prolapse. Lawsuits are pending against the pharmaceutical companies that manufacture the devices, including Johnson & Johnson, C.R. Bard, American Medical Systems (AMS), Coloplast and Boston Scientific.

The plaintiffs claim the manufacturers failed to properly warn them of the serious risks associated with their products.

Seven multidistrict litigations (MDLs) have been established to handle the cases against the manufacturers, six of which are being handled in the U.S. District Court for the Southern District of West Virginia.

In February 2014, the first federal trial accusing Johnson & Johnson of making defective transvaginal mesh began. This is the first of 15,000 cases naming Ethicon, a division of J&J, as defendants.

The practice of establishing an MDL helps cases involving similar claims and issues of fact move more efficiently through the legal system.

The federal MDL judge has agreed to hear four cases filed against each manufacturer. These are considered test trials, bellwether trials, which give plaintiffs and defendants a chance to see how jurors will react to the facts in the cases. Many times, the outcomes of bellwether trials will trigger early negotiations or settlements.

Major verdicts

In February 2013, a New Jersey state jury ordered a South Dakota woman, who suffered serious complications after she had a transvaginal mesh implant installed to treat her POP, to receive $11.1 million. She sued Johnson & Johnson and the company’s subsidiary Ethicon, which manufactured the Gyncare Prolift device. The plaintiff was a nurse who claimed she suffered mesh erosion, inflammation and scar tissue, requiring 18 corrective surgeries.

Jurors found that Johnson & Johnson failed to properly warn the plaintiff’s physician of the risks associated with the Gyncare Prolift vaginal mesh, which was manufactured by the company’s Ethicon subsidiary. The jury also found that the company misrepresented the mesh in its informational literature. The verdict was the first among the thousands of vaginal mesh lawsuits pending in New Jersey against Johnson & Johnson and Ethicon.

Gynecare Prolift was removed from the U.S. market in 2012. Johnson & Johnson voluntarily stopped selling the device after numerous lawsuits were filed. Ethicon has said it would appeal the verdict.

In 2012, California jurors awarded a woman and her husband a total of $5.5 million for her doctor and hospital bills, and her pain and suffering, following the implantation of an Avalulta Plus device, manufactured by C.R. Bard.

Filing a vaginal mesh lawsuit

Any person who suffered serious complications after having a transvaginal mesh implant inserted to treat POP may have the opportunity to recover damages for lost wages, medical bills and current and future pain. A law firm experienced in cases concerning defective medical devices can evaluate your case and determine your best legal options.

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