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Bard Composix Kugel Mesh Patch Recall Notice
Surgical Mesh Patch Injury Lawsuit Attorneys and Lawyers
Composix Kugel Mesh Patch RecallThe Bard Composix Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
The "memory recoil ring" that holds the patch open is being recalled because it can break under the stress. This can lead to bowel perforations (rapture) and/or chronic (recurring) intestinal fstulae (abnormal connections or passageways between the intestines and other organs).
Patients who have had the Patch implanted that experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms should seek medical attention immediately and contact our law offices for a free consultation.
The above Bard Composix Kugel Mesh Patch Recall List has been provided by the Food and Drug Administration, for more information regarding the recalled models please visit the FDA web site.
If you need to contact us about this matter, please click here for a free online consultation.
Transvaginal Surgical Mesh Injury
If you or a loved one was treated for stress urinary incontinence or pelvic organ prolapse with surgery that involved the transvaginal placement of surgical mesh, you may be at risk of developing serious medical complications.
An estimated 1,000 women in the United States have suffered serious injuries and complications following the surgical procedures in recent years, prompting the U.S. Food and Drug Administration to issue a public advisory about nine brands of surgical mesh.
Women who were injured by the use of transvaginal placement surgical mesh in surgeries to repair damage done by stress urinary incontinence or pelvic organ prolapse may have rights to financial compensation. Complications commonly associated with this type of surgical product include infection, pain, and perforation of the bowel, bladder, and blood vessels.
Surgical Mesh Used to Treat Stress Urinary Incontinence and Pelvic Organ Prolapse
The transvaginal placement of surgical mesh is most commonly used in surgical procedures in women suffering from stress urinary incontinence and/or pelvic organ prolapse. These painful conditions may be corrected through surgeries, but in many cases, the mesh used in the surgery to prevent the problems has resulted in painful injuries for patients.
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 surround the pelvis resulting from childbirth and pregnancy. In time 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.
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 child birth, 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 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.
Surgical Mesh as a Treatment Option
Surgeons commonly use surgical mesh in procedures to treat stress urinary incontinence and pelvic organ prolapse. By using mesh to strengthen the internal organs and prevent them from coming into contact with one another, a surgeon may be able to reduce pain and other symptoms. However, many women have complained of suffering painful injuries as a result of the use of transvaginal placement of surgical mesh. In some cases, surgeons have had to perform additional procedures to remove the mesh.
Surgical Mesh Patch FDA Warning
In October 2008, the FDA issued a public health notification to warn consumers about the risks of complication 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.
FDA Warns of Vaginal Mesh Dangers
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 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.
Serious Complications Reported
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 the 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.
When is the Transvaginal Placement of Surgical Mesh Used?
The transvaginal placement of surgical mesh is most commonly used in surgical procedures to treat stress urinary incontinence and/or pelvic organ prolapse in women. The mesh is placed along the vaginal wall to protect the area and is designed to be left permanently inside the body.
Vaginal Mesh Injuries
Women injured by the transvaginal placement of surgical mesh may suffer a wide range of injuries, including infection, bladder pain, urinary problems, and a recurrence of the condition for which the surgery was done. There have also been reports of bowel, bladder, and blood vessel perforation during insertion of the mesh and of vaginal scarring and mesh erosion.
Painful Bowel and Bladder Perforations Among the Common Surgical Mesh Injuries
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.
