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Surgical Mesh Patch, Hernia and Transvaginal Mesh Patch Injury |
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Surgical Mesh Patch
The 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.
| Product Code |
Description |
Lot Numbers Recalled |
Date Recalled |
| 0010206 |
Bard® Composix® Kugel®
Extra Large Oval,8.7” x 10.7” |
All Lot Numbers manufactured before January 2006 |
December 2005
January 2006 |
| 0010207 |
Bard® Composix® Kugel®
Extra Large Oval, 10.8” x 13.7”
|
All Lot Numbers manufactured before January 2006 |
December 2005
January 2006 |
| 0010208 |
Bard® Composix® Kugel®
Extra Large Oval, 7.7” x 9.7” |
All Lot Numbers manufactured before January 2006 |
December 2005
January 2006 |
| 0010209 |
Bard® Composix® Kugel® Oval, 6.3” x 12.3” |
All Lot Numbers manufactured before March 2006 |
March, 24, 2006 |
| 0010202 |
Bard® Composix® Kugel®
Large Oval, 5.4” x 7.0” |
Lot Numbers manufactured before October 2005 |
January 10, 2007 |
| 0010204 |
Bard® Composix® Kugel®
Large Circle, 4.5” |
Lot Numbers manufactured before October 2005 |
January 10, 2007 |
Source: 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.
Injury from the surgical mesh patch can cause serious health risks to you or someone you love, if you believe that you have been injured by a defective Hernia Mesh Patch or the Transvaginal Surgical Mesh Patch contact our law firm for a free online or telephone consultation. You have rights, and you may be entitled to compensation for your medical bills, pain, suffering, lost wages, wrongful death and other damages. Contact us by clicking here.
Transvaginal Mesh Patch
Injury from stress urinary incontinence and/or pelvic organ prolapse surgery mesh patch.
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.
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 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.
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.
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.
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.
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.
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.
Injury from the surgical mesh patch can cause serious health risks to you or someone you love, if you believe that you have been injured by a defective Hernia Mesh Patch or the Transvaginal Surgical Mesh Patch contact our law firm for a free online or telephone consultation. You have rights, and you may be entitled to compensation for your medical bills, pain, suffering, lost wages, wrongful death and other damages. Contact us by clicking here.
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.
Do You Have Questions?
Injury from surgical mesh patch can lead to serious and life-threatening complications. It is important to understand your rights, contact us today for a free consultation.
Pelvic Mesh: FDA announces "clear risks"
July 18, 2011 - Edward Nitkewics
 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 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 transvaginal placement of surgical mesh increased significantly from the period of 2008 to 2010.
J&J Vaginal Surgical Mesh Faces FDA Panel as Number of Lawsuits Increase
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.
Marci Sutin Levin, a New York marketing executive who has sued J&J over her injuries, says the FDA failed her when they didn't require extensive testing before allowing J&J to sell the mesh implanted in her in 2007.The device was cleared under the agency's 510(k) process, which allows approval without substantive studies if a product is "substantially equivalent" to others already on the market.
While the mesh has been used for more than three decades, mainly for hernias, its use "has evolved over the past few years" as manufacturers expanded into other conditions, Herbert Lerner, an acting director in the FDA's device-approval center, told the panel today. "As industry modified surgical mesh for these indications, none of the mesh has been evaluated for clinical data."
Levin, 65, is one of about 75,000 women-a-year who have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse. She said in an interview that she endures pain so intense she can't work, sleep through the night or have sex with her husband. It hurts worse than natural childbirth, she said.
‘Pain of Childbirth'
"The pain of childbirth was finite, and you're delivering a child," Levin said in an interview. "This was very, very different. It's relentless, and it's untenable. And it doesn't lead to anything."
Levin filed one of about 270 lawsuits pending against J&J, based in New Brunswick, New Jersey. Bard, of Murray Hill, New Jersey, and other mesh makers also face litigation around the U.S. About 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse.
The FDA warned July 13 of a rise in injuries related to the mesh, and it said last month the devices should be reclassified from moderate risk to high risk, a change that would typically require new clinical data.
The advisory panel will also discuss mesh used for stress urinary incontinence in addition to whether transvaginal mesh for pelvic organ prolapse, or POP, is safe and effective.
J&J fell 55 cents to $64.88 at 9:32 a.m. in New York Stock Exchange composite trading. Bard declined 76 cents to $93.45.
Institute of Medicine Report
The FDA is weighing a U.S. Institute of Medicine report in July urging it to scrap the 510(k) process for moderate-risk devices. The current system allows devices like the mesh implant to enter the market if manufacturers show they are "substantially equivalent" to others already for sale. The IOM said a new process should be devised that provides reasonable assurance of the safety and effectiveness of moderate-risk devices.
"The clinical effectiveness of surgical mesh for transvaginal repair of POP has not been demonstrated," said William Maisel, deputy director of the FDA Center for Devices and Radiological Health, in a telephone interview. "We believe proper studies would need to be done."
An industry working group disputes the FDA's suggestion that the devices should be reclassified. Its members include mesh makers J&J; Bard; Boston Scientific Corp. (BSX) of Natick, Massachusetts; and American Medical Systems, acquired in June by Endo Pharmaceuticals Holdings Inc. (ENDP) of Chadds Ford, Pennsylvania. The Advanced Medical Technology Association, the manufacturers' lobbying arm in Washington, is also a member.
‘Safe and Effective'
The group believes that the use of mesh in transvaginal procedures for prolapsed organs is "safe and effective, that serious adverse events remain rare and it is a valuable treatment option for women," it wrote on Aug. 30 to the advisers. "Key to the successful treatment of POP with surgical mesh is appropriate patient selection and surgeon experience."
A spokesman for J&J, Matthew Johnson, declined comment on the litigation. Bard spokesman Scott Lowry declined to comment on about 190 lawsuits it faces over its Avaulta pelvic mesh.
Adam Slater, the New Jersey attorney who represents Levin and about 100 other women who have sued J&J or Bard in New Jersey state court, said the agency is "at an important crossroads" over how to protect patients.
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