Update on Transvaginal Mesh Litigation

We are at the forefront of Chicago law firms representing women injured by surgical mesh, a product used to treat pelvic organ prolapsed (POP) and Stress Urinary Incontinence (SUI). Made of woven polyester, polypropylene or other materials, the mesh is permanently implanted in the vaginal wall.

Thousands of women have been seriously injured by implantation of surgical mesh to relieve and support weakened pelvic muscles. As early as 2008, the U.S. Food and Drug Administration (FDA) issued a public health notice concerning serious complications associated with use of surgical mesh including vaginal erosion, pelvic organ and vascular perforation, neurologic damage and pain. Yet these devices remain in use.

In February of 2013, a New Jersey jury delivered the first verdict in more than 2,000 lawsuits filed against manufacturers concerning surgical mesh in the United States. Linda Gross, a 47-year old hospice nurse from South Dakota received the Gynecare Prolift mesh implant in 2006 as a remedy to pelvic prolapse. Manufactured by Ethicon, a subsidiary of Johnson and Johnson (JNJ) based in New Jersey, Ms. Gross experienced no relief from the product, and instead faced 18 additional operations to address pain and internal damage as the mesh eroded.

In her product liability lawsuit, the jury awarded Ms. Gross $3.35 million in compensatory damages and $7.8 million in punitive damages. Although the jury did not find the Ethicon product was defective, it found the company provided insufficient warning prior to use of the device by her surgeon and misrepresented risks of the product.

Although Gynecare Prolift was removed from the market in 2012, Ms. Gross must self-catheterize simply to urinate because of the damage done to her by the mesh. This first verdict gives hope to women across the country injured by mesh products.

If you have suffered harm from a transvaginal mesh implant, talk to us about your injury.

Understanding Pelvic Organ Prolapse

Hundreds of women who received mesh to treat pelvic organ prolapse (POP) are suing manufacturers and physicians for injuries suffered as a result of the procedure.  As the focus on damage caused by improper treatment intensifies, the interest in what causes POP continues to grow.  What exactly is pelvic organ prolapse?

Symptoms of pelvic organ prolapse

For women, the relaxation of ligaments and muscles in the pelvic region sometimes allows for the intrusion of the bladder, colon, or uterus into the vagina. Upper vaginal tissue can also bulge into the lower vaginal area.  By one estimate, 40 to 70 percent of all women suffer some form of pelvic floor weakness during their lives.

Symptoms of POP are varied and include:

  • A sensation of pressure, or a protrusion, in the pelvic region
  • Bulging in the vaginal or perineal area
  • Urinary incontinence, or frequency or urgency of urination
  • Straining to defecate
  • Painful intercourse
  • Pelvic or lower back pain

Pelvic floor muscles weaken with age, leaving connective ligaments to support internal organs.  When ligaments weaken, tissue presses into the vaginal wall.  POP is more likely to occur following multiple vaginal births, after menopause, or as the result of obesity.

Treatment of POP

Mild cases of POP are treated with Kegel and other exercises designed to strengthen pelvic floor muscles. A pessary, estrogen supplements, or laparoscopic surgery can reduce or resolve symptoms.

Pelvic organ prolapse is relatively common and usually treatable. If you have suffered injury from implanted transvaginal mesh treatment for POP, be sure to seek experienced legal advice concerning your legal options.

Transvaginal Mesh: Never Tested?

Serious complications, loss of sexual pleasure, constant pain: a sad combination. Women who underwent vaginal placement of surgical mesh experience these losses daily, and wonder how this damaging procedure could have been recommended for them.

Our firm is at the forefront of Chicago attorneys aggressively pursuing compensation for victims of transvaginal mesh placement. Injuries from pelvic mesh result from failure of the medical device itself or medical error in implanting the device.

Sorting through accounts of the horrific damage done to women with implanted surgical mesh raises the pointed question of how this procedure was approved by the U.S. Food and Drug Administration (FDA).

In 2008, the FDA issued a public health notification that warned about these devices. In 2011, the FDA issued an update, noting that serious complications are not rare and that the benefits of the procedure are no greater than those of other less dangerous options available to treat pelvic organ prolapse (POP).

In May 2012, the non-profit organization Consumer Reports offered an in-depth article on dangerous medical devices. In discussing transvaginal mesh troubles, the authors detailed the entry of pelvic mesh kits onto the medical market by manufacturers claiming substantial equivalence to previously approved hernia repair kits.

Without recalling the product, the FDA ordered safety studies earlier this year. Since then, Johnson & Johnson subsidiary Ethicon has taken four mesh kits off the market.

In 2010 alone, about 100,000 women received surgical mesh to treat pelvic organ prolapse. The slipshod approval process that led to the unnecessary daily suffering of so many women must be changed — if not by regulation, then by litigation.  If you have suffered serious injury as a result of transvaginal mesh implantation, contact a personal injury attorney in our office to determine if you are eligible for compensation.

Transvaginal Mesh Litigation — Is It for You?

Civil lawsuits are an important part of our legal system. Without this recourse, many victims of negligence, injurious pharmaceuticals and faulty medical devices would have no way to recover compensation for medical bills, lost wages and the many other consequences of injuries sustained through no fault of their own.

Suing for transvaginal mesh injury

If you were hurt by the implantation of transvaginal mesh, you are not alone.  About one thousand cases have been consolidated in multidistrict litigations (class action lawsuits) in the Southern District of West Virginia and the Middle District of Georgia. The first of the West Virginia cases is slated for trial in February 2013.

Thousands of women were injured by pelvic mesh, a product still on the market. While pursuing legal action seems difficult, consider these points:

  • An experienced personal injury attorney investigates the unique facts of your case, and provides straightforward counsel on your chances for compensation
  • Reputable personal injury firms do not charge for services, but are paid from the proceeds of compensation obtained on your behalf
  • Filing a timely claim is important to preserve your right to compensation

Well-established in the Chicago area, our firm works hard to obtain fair compensation for each of our clients injured by transvaginal mesh implants. If you have questions about a possible case, or about the legal process itself, talk to us. The call is free.

Transvaginal Mesh Multi District Litigation

Transvaginal mesh is a synthetic fiber sling that is implanted through the vagina. It is used to prevent instances of pelvic organ prolapse in women, a condition in which organs such as the bladder, uterus, and lower digestive tract begin to descend. This type of treatment has existed since the 1990s. But since that time, numerous issues with the mesh, including mesh erosion, organ perforation, pain and abdominal pressure, infections, bleeding, and urinary incontinence, have emerged. This prompted the FDA to issue a public health notification in 2008 followed by an updated advisory and safety study order in 2011.

Numerous cases — both individual and class action suits — are pending against the various companies that manufacture transvaginal mesh. The majority of the individual cases pending in federal court have been consolidated in the United States District Court for the Southern District of West Virginia under one of five multidistrict cases — each against one of the major manufacturers of pelvic mesh: C.R. Bard, Inc.; American Medical Systems, Inc.; Boston Scientific Corp.; Ethicon, Inc.; and Coloplast Corp.

If you or a loved one had transvaginal mesh implantation and experienced pain, incontinence, or other side effects or had to have further surgery to have the mesh repaired, reimplanted, or removed, you may be entitled to monetary compensation from the manufacturer. As a victim, you have many options for pursuing a products liability claim. An experienced attorney at Phillips Law Offices can examine your specific situation and help you determine which course of action is best suited for you.

A Concerning Letter from Johnson & Johnson: TVM and Your Safety

As far back as 2007, Johnson & Johnson had been warned by the Food and Drug Administration (FDA) to discontinue marketing its Gynecare Prolift® transvaginal mesh (TVM) implant. The vaginal mesh is a device used to treat stress incontinence. Women who have this condition must contend with involuntarily bladder leakage brought about by weak uterine wall muscles. The urine discharge usually occurs when affected women sneeze, laugh or engage in a similar activity that uses these muscles in the body. Several manufacturers in addition to Johnson & Johnson have created vaginal meshes that have had serious side effects for women.

Continuing sale in spite of FDA warning

When Johnson & Johnson received the letter of reprimand from the FDA, it chose to ignore it and continued to sell these defective products for another nine months. When the company did finally discontinue producing and selling the Gynecare Prolift vaginal mesh implant, it was due to declining profits and not concern over women’s health risks. Unfortunately, the FDA lacked the power to sanction Johnson & Johnson for deliberately defying the mandates of its reprimand. However, the FDA did issue a warning to all users of the transvaginal mesh in June of 2011. This warning was prompted by complaints about numerous other manufacturers and different types of mesh slings.

Phillips Law Offices in Chicago is available to evaluate your claim if you have been injured by a defective transvaginal mesh product. There are several possibilities for claims, including manufacturing and design defects, failure by manufacturers and doctors to warn women of the risks, and more. Our team of experienced medical malpractice lawyers focuses on TVM cases, and we thoroughly research the facts in your case in order to determine whether a product liability lawsuit can be filed on your behalf. It is our goal to get you the compensation you need to cope with added medical expenses and unnecessary pain and suffering.

Are You Eligible To Sue If You Have Been Harmed By A TVM Product?

Transvaginal mesh (TVM) is a medical device used mostly in recent years to treat stress incontinence. Women who have this condition may involuntarily pass urine when they laugh, cough, sneeze or lift heavy objects. Stress incontinence is caused by weak pelvic floor muscles, which may be caused by childbearing, aging or any number of combinations.

Original reports of the transvaginal mesh procedure estimated its success rate at 95 percent, but that figure has since been disproven. In fact, thousands of injuries and at least seven deaths have been attributed to the transvaginal mesh. The primary problems associated with it include infection and perforation of the bladder and other organs. The following list is just some of the serious side effects of the transvaginal mesh that have been reported to the Food and Drug Administration (FDA):

  • Vaginal and urinary tract infections
  • High fever
  • Odor
  • Pain during intercourse
  • Bleeding
  • Bladder leakage
  • Back pain
  • Painful bowel movements

Ironically, the bladder leakage that the transvaginal mesh was used to treat becomes worse instead of better and women end up with many new symptoms as well.

At Phillips Law Office in Chicago, we understand that you may have several questions about a possible medical malpractice lawsuit. We have a strong focus on transvaginal mesh cases, and we are here to help you sort through them and evaluate your case. You will have no upfront costs if you decide to work with our attorneys. All of the personal injury lawyers at Phillips Law Office take cases on contingency, which just means that you don’t pay until we successfully settle your lawsuit. Without legal fees to worry about, you can focus your energies on recovering from this serious medical error.