Please note that we are no longer accepting cases for Transvaginal Surgical Mesh.
Has it eroded, contracted or adhered to surrounding organs? There are a host of symptoms associated with these injuries including pain, bleeding, bladder control problems, recurrent organ prolapse, recurrent urinary infections, painful intercourse, and even compromised function of surrounding organs.
Find out for free if you are eligible for financial compensation. You have rights and you may be entitled to compensation for your medical bills, pain, suffering, lost wages, wrongful death and other damages.
State and federal courts and juries nationwide are awarding multi-million dollar settlements and jury verdicts to certain women who have suffered injuries and complications from allegedly defective transvaginal mesh implants.
Mesh manufacturers Johnson & Johnson, American Medical Systems, C.R. Bard, Boston Scientific, and Coloplast have paid out more than $200 million since 2012 to women alleging that the companies’ mesh implants intended to stop pelvic organ prolapse and stress urinary incontinence were not adequately designed or tested before being marketed to women. A settlement agreement between plaintiffs and American Medical Systems will provide up to an additional $830 million to 20,000 women allegedly injured by the defective implants, if settlement participation thresholds are met.
Multiple revision surgeries often required to remove the defective mesh from women’s bodies
Often, allegedly defective transvaginal mesh implants must be explanted, or surgically removed, sometimes by a series of painful and expensive operations. Lawsuits allege that some women have undergone multiple revision surgeries in attempts to excise all portions of the mesh form their bodies. For some women, ultimately removing the device has not stopped symptoms of pain and bleeding, nor cured their inability to have sexual intercourse.
Surgical mesh mass tort lawsuits are the biggest multi-district litigation in history
Transvaginal mesh is offered to women as a less invasive and less expensive alternative to corrective surgery that tightens muscles and ligaments. According to Drugwatch, in 2010 alone, over 300,000 transvaginal mesh surgeries were performed nationwide.
The preponderance of mesh implants among American women and the discovery that such implants may be inherently defective has caused the coordinated transvaginal mesh mass tort lawsuit to be named the biggest multi-district litigation in history.
Courts urge manufacturers to settle claims of women injured by mesh products
Courts have urged mesh manufacturers to cut their losses and settle outstanding claims with women allegedly injured by their products. Jury verdicts in bellwether trials conducted thus far have awarded enormous sums to individual plaintiffs that include compensatory and punitive damages. In September 2014, a Texas state jury awarded $73 million to a plaintiff alleging injuries from Boston Scientific’s mesh implant. A New Jersey verdict granted $11 million in 2013 to a woman injured by Johnson & Johnson’s Ethicon Gynecare implant. In 2012, a jury in California awarded $5.5 million a woman injured by C.R. Bard’s Avaulta mesh product.
PUBLIC HEALTH NOTIFICATION
FDA Issues Public Health Notification
In October 2008, the FDA issued a public health notification to warn consumers about the risks of complications from the transvaginal placement of surgical mesh. Although rare, the complications posed serious health risks to women. The FDA recommended that physicians receive additional training in the use of the products and give more information to patients about the mesh in an effort to reduce injuries and complications.
In some cases, vaginal scarring that resulted in significant discomfort and pain was reported. Patients also noted a decrease in their quality of life a result of the pain and scarring. The size and shape of the mesh, the surgical technique used in placing the mesh inside the body, the patient’s estrogen levels, and other factors appeared to contribute to the risk of complications, the FDA said.
According to the FDA, during a three-year period, more than 1,000 women reported complications from the surgical mesh. Reports of the mesh eroding through the vaginal wall, infection, pain, urinary problems, and recurrence of the underlying problem for which surgery was initially performed we received. Bowel, bladder, and blood vessel perforations also were been reported, and in many cases, these complications required extensive additional surgeries to correct.
PELVIC ORGAN PROLAPSE
Pelvic organ prolapse is a common condition, particularly among older women who have given birth at some point in their lives. Following pregnancy and childbirth, the muscles and tissue supporting the uterus, bladder, and other pelvic organs may be stretched out and weakened. As a result, the organs may shift around inside the body and create problems.
The bladder may be prolapsed and fall toward the vagina, creating a large bulge in the front vaginal wall. The bladder and the urethra commonly prolapse together, creating a condition called a cystourethrocele that is the most common type of prolapse seen in women. Pelvic organ prolapsed can occur in several degrees, commonly called mild, moderate, and severe, depending on the degree of movement and the number of internal organs affected.
STRESS URINARY INCONTINENCE
Stress urinary incontinence is a condition in which urine leaks from the body during regular daily activities such as coughing, laughing, sneezing, or exercising. The condition is most often caused by weakness in the muscles surrounding the pelvis resulting from childbirth and pregnancy. In times of increased pressure on the abdomen, the weakened muscles in the pelvis can allow the urethra to involuntarily leak urine. In women, stress urinary incontinence can require surgery to correct, but in men, the condition is common and more easily treatable.
Women may find that stress urinary incontinence worsens during the week before their menstrual period, when decreased estrogen levels may lead to lower muscular pressure around the urethra and increase the chances of leakage. The incidence of stress incontinence also increases following menopause, also as a result of decreased levels of estrogen.
Women who undergo surgical procedures for the treatment stress urinary incontinence and/or pelvic organ prolapse may suffer a variety of serious injuries caused by the transvaginal placement of surgical mesh. The procedure can result in severe pain, urinary problems, and other complications. In many cases, additional surgeries are required to remove the mesh in an effort to correct the problems.
J&J VAGINAL SURGICAL MESH FACES
J&J VAGINAL SURGICAL MESH FACES FDA PANEL AS NUMBER OF LAWSUITS INCREASE
July 18, 2011 – Edward Nitkewicz
The Food and Drug Administration (“FDA”) announced last week that transvaginal placement of surgical mesh in connection with Pelvic Organ Prolapse repair poses “greater risk than other surgical options.”
According to the American Urogynecologic Society, pelvic organ prolapse is a medical condition that occurs when the normal support of the vagina is lost, resulting in “sagging” or dropping of the bladder, urethra, cervix, and rectum. As the prolapse of the vagina and uterus progresses, women can feel bulging tissue protruding through the opening of the vagina.
As the prolapse gets worse, some women complain of:
- A bulging, pressure or heavy sensation in the vagina that worsens by the end of the day or during bowel movements
- The feeling that they are “sitting on a ball”
- Needing to push the stool out of the rectum by placing their fingers into the vagina during bowel movement
- Difficulty starting to urinate, a weak or spraying stream of urine
- Urinary frequency or the sensation that they are not emptying their bladder well
- The need to lift up the bulging vagina or uterus to start urination
- Urine leakage with intercourse
The FDA announcement stated that it was now recommending to physicians to “carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.”
The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.
Adverse Event reports to the FDA regarding the transvaginal placement of surgical mesh increased significantly from the period of 2008 to 2010.
September 8, 2011 – David Voreacos and Alex Nussbaum
Johnson & Johnson (JNJ) and C.R. Bard Inc. may have to submit more safety data on a type of surgical mesh that has led to about 500 lawsuits against the manufacturers.
A panel of U.S. Food and Drug Administration advisers is meeting today and tomorrow on whether the mesh, which supports weakened muscles that can’t hold a woman’s pelvic organs in place, is safe and effective. If not, the device makers may be required to provide more data to keep their products, approved by regulators under an abbreviated process, on the market.
Gynecare Prolift Vaginal Mesh Sold by J&J for 3-years Without FDA Approval
March 21, 2012
According to a recent report, Johnson & Johnson sold their Gynecare Prolift mesh for several years before obtaining FDA approval, and the manufacturer now faces a number of product liability lawsuits brought by women who suffered complications allegedly caused by design defects with the vaginal surgical mesh. Johnson & Johnson’s Ethicon unit began selling the Prolift mesh in March 2005, but it was not approved by the FDA until May 2008, three years later.
The FDA did not know that the device was on the market until 2007 when the manufacturer asked for approval for a related device, both are used to treat pelvic organ prolapse and female stress urinary incontinence.
According to a recent report by Bloomberg News, Johnson & Johnson believed it was allowed to sell the Gynecare Prolift mesh without approval because it was substantially similar to the Gynecare Gynemesh, which was already on the market. However, the FDA has taken issue with this assertion.
Between the release date of the Prolift mesh and the FDA actually approving it for sale, there were 123 adverse event reports associated with the product, including reports of death and serious injury, according to Bloomberg. The fact that doctors and patients were reporting problems with a medical device that the FDA had not approved without raising alarm bells raises questions about the agency’s oversight over approved medical devices.
The Ethicon Gynecare Prolift mesh is now one of a number of surgical mesh products manufactured by Johnson & Johnson, as well as other companies, that are the subject product liability lawsuits nationwide. Hundreds of women are presenting claims that allege they suffered painful and debilitating complications after the vaginal mesh was implanted, such as pelvic pain, infection, and erosion of the mesh through the vagina.
All vaginal mesh lawsuits involve similar allegations that the manufacturers failed to adequately research and test their products, rushing the products to the market through the FDA’s controversial fast-track approval system, which allows the agency to approve medical devices without rigorous pre-market testing when they feature a substantially similar design to other previously approved products.
Johnson & Johnson reportedly failed to even obtain 510(k) approval before marketing the Gynecare Prolift mesh.
Public awareness about the risk of the vaginal mesh problems increased last year after the FDA issued warnings about an increasing number of adverse event reports associated with the products. In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.
About Sanders Phillips Grossman
Sanders Phillips Grossman has been holding pharmaceutical companies responsible for injuring individuals by their defective drugs and devices for over 30 years. Defective drugs are pharmaceuticals with side effects that potentially harm, injure, or kill the patient to the point that they outweigh the drug’s intended benefits. Defective devices, such as faulty prosthetics, implants, pacemakers, or surgical instruments can harm patients when the product is defective in the manufacturing process, design, or marketing strategy.
Pharmaceutical companies are some of the largest, wealthiest, and most influential corporate entities in the world. Sanders Phillips Grossman and its predecessors have recovered over one billion dollars for injured consumers. Our firm’s history in dealing with drug and medical device injury claims has allowed us to take leadership roles in many of the national defective drug and device litigations.
Nationally recognized as a leading plaintiff’s law firm, we handle cases in all 50 states and Puerto Rico.
Read more about our attorneys here.