Thousands of adverse event reports to the Food and Drug Administration (FDA), however, have brought to light the serious complications that can result from surgery with vaginal mesh. A recent Gynecare mesh FDA warning and subsequent Gynecare mesh FDA hearing illuminated the seriousness of this issue, and have led some to speculate on the possibility of a Gynecare mesh recall.

Why a Possible Gynecare Prolift Recall?

Many women 50 years and older experience POP, a condition in which the pelvic muscles and tissues become weakened and stretched due to childbirth, menopause, or surgeries. These muscles are then no longer able to support pelvic organs like the bladder, urethra, and bladder. One or more of these organs may then fall or drop forward into the vaginal wall.

Severe forms of POP may be treated with surgery, which may involve Gynecare Prolift. Manufactured by Ethicon, a subsidiary of Johnson & Johnson, Gynecare Prolift and other similar vaginal meshes were hailed as an improved solution to traditional non-mesh surgery because they reduce the risk of recurrence. Unfortunately, they also cause more post-treatment Gynecare mesh complications.

Gynecare Mesh FDA Warning

In 2008, the FDA warned about possible complications with vaginal mesh surgeries, but noted that these complications were rare. Then, between 2008 and 2010, the agency received five times as many reports of vaginal mesh problems as they had between 2005 and 2007. At the same time, new studies emerged highlighting the risks of complications, including mesh erosion into the vagina or other organs, scar tissue formation, infections, pelvic pain, urinary incontinence, and recurrence of prolapse.

In July 2011, the FDA issued an updated Gynecare mesh FDA warning stating that complications with vaginal mesh are not rare, and that it is unclear if POP repair with products like Gynecare Prolift is better than traditional non-mesh repair. The agency warned physicians to be aware of the risks, and to tell their patients that some of the complications may not be reparable even with additional surgeries.

Gynecare Mesh FDA Hearing

Following the updated warning, the FDA convened a subcommittee meeting to further evaluate the safety issues with products like Gynecare Prolift. As a result, the Obstetrics & Gynecology Devices Panel agreed that the safety of these devices has not been established, and that further clinical studies are needed to better explain the risks and benefits.

Critics Call for Gynecare Mesh Recall

Some concerned organizations and healthcare professionals have suggested that a Gynecare mesh recall may be the only way to ensure the safety of women going through POP surgery. Gynecare mesh lawyers feel the Gynecare Prolift did not meet reasonable safety standards, and that the company did not adequately warn of the potential risks. So far, however, no Gynecare mesh recall has taken place.

A Gynecare Mesh Lawyer May be Able to Help

If you or a loved one has experienced an injury as a result of Gynecare Prolift mesh, you may be eligible for compensation in a Gynecare mesh lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.

Patients Suffering From Complications

The purpose of a Gynecare mesh settlement is to financially compensate individuals who have been adversely affected by the Gynecare mesh product. Patience have been undergoing a surgical procedure that uses the Gynecare mesh to reverse the effects of vaginal prolapse. Vaginal prolapse (to fall out) is a condition in which the tissues of the vagina become loose and stretch – causing the pelvic organs surrounding the vagina to lose the support system that holds them in place.

This particular medical procedure is referred to as a Gynecare repair surgery, and unfortunately it has to some unwarranted side effects in women. Additionally, these adverse effects have caused victims to seek Gynecare lawyers to assist in possible Gynecare settlements.

Adverse Effects of Gynecare Mesh

Through research and testing, it has been found that 2% to 3% of women who underwent a Gynecare repair surgery have experienced erosion of the mesh. The result of mesh erosion may lead to subsequent health complications – which include the following:

• Infection
• Severe pain
• Perforation of the bladder, bowel or blood vessels.
• Reoccurrence of the same condition

An additional 1,000 reports of Gynecare mesh complications were given to the U.S. Food and Drug Administration. The combination of the studies and reports given to FDA caused alarm – and as a result a public health warning was announced regarding the possibility for Gynecare mesh erosion and its subsequent side effects.

Lawyers can Help With a Possible Gynecare Settlement

Gynecare lawyers have discovered through other Gynecare settlements that some Gynecare mesh patience have been adversely affected by Gynecare mesh complications. If you or a loved one has suffered any side effects after a Gynecare mesh repair surgery, you may be entitled to compensation through a Gynecare settlement. A Chaffin Luhana, LLP Gynecare lawyer is available to speak with you regarding a potential Gynecare lawsuit today. Call our toll free number today for a free, no-obligation case evaluation: 1-888-480-1123.

What is the Gynecare repair system?

The Gynecare repair system is one of several brands of vaginal mesh used to treat stress incontinence in women. When women suffer from stress incontinence, they experience urine leakage during sudden movements, such as coughing or laughing. To treat this disruptive problem, a surgeon may use a vaginal mesh tape, such as that found in the Gynecare repair system, to provide support to the prolapsed urethra that the weakened pelvic muscle can no longer provide.

What are the dangers of Gynecare repair system?

The American College of Obstetricians & Gynecologists says it shares the FDA’s concern about the health risks of surgical mesh products, such as the Gynecare repair system.

These health risks include infection and urinary problems. A common problem among patients reporting adverse effects of a vaginal mesh procedure was pain during sexual intercourse. Some patients have suffered when the mesh becomes exposed through the vaginal tissue. Other incidents include organs perforated during the surgical procedure.

Despite these health risks, more than 75,000 transvaginal procedures were performed during 2010 to insert vaginal mesh tapes, such as in Gynecare repair surgeries. Yet, an FDA study found that mesh surgeries were no more beneficial than other procedures despite their increased health risk. Furthermore, removal of the vaginal mesh did not always resolve the adverse reactions reported.

The FDA goes on to say that “there are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse.” The FDA is urging health-care providers to treat stress incontinence and other types of pelvic organ prolapse without the use of vaginal mesh, like the kind found in the Gynecare repair system.

Hiring a Gynecare repair surgery lawyer

If you or a loved one has suffered an injury that may be related to the use of the Gynecare vaginal mesh repair system, you should contact one of Chaffin Luhana LLP’s Gynecare lawyers, who are knowledgeable about Gynecare complications. Call 1-888-480-1123 immediately for a free and confidential case review.

You may be entitled to compensation from a Gynecare lawsuit, and the experienced lawyers at Chaffin Luhana can help.

The Gynecare Prolift Pelvic Floor System is a vaginal mesh that was developed to surgically treat women suffering from female pelvic organ prolapse. Genital prolapse is defined as the projection of part of the vaginal canal from the vagina’s opening, typically caused when a pelvic organ such as the bladder slips from its normal position and exerts pressure on the vaginal walls. Such pelvic organ prolapse most commonly occurs as a result of childbirth, although some women have experienced this condition as a surgical complication.

Vaginal meshes such as the Gynecare Prolift Pelvic Floor System are designed to reposition one’s pelvic organs. Unfortunately, the vast majority of these meshes, including the Gynecare model, have shown possible links to serious or even life-threatening diseases. Consumers who believe that their health has suffered as a result of this product should consult a Gynecare lawyer for further action.

Possible Gynecare Mesh Complications

The FDA has cited numerous different consumer reports regarding Gynecare mesh complications, the most common being vaginal erosion. It is suspected that insertion of the Gynecare mesh might cause deterioration of the vaginal epithelium. Infection is also a possible result of Gynecare mesh surgery. Some researchers assert that the Gynecare mesh can lead to infection both through damage of vaginal tissue at the time of the mesh’s insertion and through inhibition of proper oxygen and nutrient exchange to and from the vaginal cells. Finally, dyspareunia has been cited as a possible Gynecare complication. Consumers should consult their Gynecare lawyer for further information regarding this product’s health concerns.

Hiring a Gynecare Lawyer

If you believe that you have suffered as a result of this vaginal mesh, you should seek the services of a Gynecare lawyer for assistance in pursuing your Gynecare lawsuit. A Gynecare lawyer can help you to obtain the Gynecare repair and compensation that you deserve. Contact our professional health care lawyers today to learn more about the many options that are available to you.

Each year, thousands of women have corrective surgery to repair pelvic organ prolapse, a condition where weakened pelvic muscles allow the bladder to drop down and push against the vaginal walls. One of the most popular products to repair this medical condition is transvaginal mesh, such as the Gynecare Prolift Pelvic Floor System. Unfortunately, the U.S. Food and Drug Administration (FDA) has received a significant number of complaints that have resulted from the use of transvaginal mesh and vaginal slings. Gynecare complications can be painful and sometimes fatal.

Reported Gynecare Complications

The most common complaint among Gynecare Prolift Pelvic Floor System patients is mesh erosion. When the Gynecare mesh is surgically inserted, the patient may suffer from trauma caused by bladder, bowel and blood vessel perforation. This trauma is believed to be the cause of vaginal mesh erosion.

Patients also report the surgical insertion of the Gynecare Prolift Pelvic Floor System has led to serious infection. Infection could be caused by bladder, bowel and blood vessel perforation. Also, the vaginal mesh may be blocking tissue from absorbing nutrients and oxygen, which impairs healing and eventually leads to infection. Infection can lead to death, which makes this the most serious of the Gynecare complications.

Some patients have reported persistent or recurring pain caused by the Gynecare Prolift Pelvic Floor System. Most commonly, patients complain that the Gynecare complications cause pain before, during or after sexual intercourse, otherwise known as dyspareunia. As a result, these patients often have the Gynecare mesh surgically removed.

Relief For Those Facing Gynecare Complications

If you or a loved one has suffered from complications as a result of the Gynecare Prolift Pelvic Floor System or another vaginal mesh or sling, you may be eligible for legal claims to compensation for medical bills, lost income, pain and suffering. A multi-district Gynecare lawsuit is now underway, but injured parties must respond before their claims expire, the date of which depends on the brand of vaginal mesh used in their situation.

Call Chaffin Luhana Gynecare lawyer today to learn about your legal rights regarding these faulty products. A Gynecare lawyer can evaluate your medical records and advise you of your chance at recovering through a lawsuit against a vaginal mesh manufacturer. Gynecare lawsuits have the potential to bring relief to the thousands of patients who suffer daily from Gynecare complications.