Transvaginal Mesh Lawsuit

The recent transvaginal mesh lawsuits that were field against large companies such as Johnson & Johnson, Boston Scientific Corp, C.R. Bard, Inc., Coloplast Corp., and Cook Medical Inc. reveal that resorting into a transvaginal implant is indeed a very serious matter.

Even though companies and manufacturers often assure that the adding the said implant is a low-risk procedure, it is still acceptable to assume that it may still provoke complications that are truly life-changing. In fact, reported cases exhibit that women could actually suffer from serious problems that may include organ perforation, infection, device erosion, inability to engage in sexual intercourse and intense pain.

If you were a woman who has used a transvaginal implant before, do something now. Read about a recent Transvaginal Mesh Lawsuit and learn from the experiences of those who suffered from the adverse effects of the material. If you know someone who has had an implant before, inform her.



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Mesh Lawsuits

Transvaginal mesh lawsuits are one on the rise due to the adverse effects precipitated by transvaginal mesh. Transvaginal mesh is utilized in the treatment of pelvic organ prolapse, a condition in which organs fall via pelvic floor into the birth canal and then stress urinary inconsistence. Even though patients were assured that insertion of transvaginal mesh was a minimal risk procedure, its complications have been found to be life threatening. Several women who have transvaginal mesh inserted into their birth canal have experienced the adverse effects and complications below.

Difficulty in urinating or urinary tract obstruction

Pain during sexual intercourse

Irritation, inflammation or infection

Injury to urethra, bowel or bladder

Injury to the blood vessels of the pelvis

No correction of urinary inconsistence.

Manufacturers of medicines and medical devices have an obligation of ensuring the safety and efficacy of products they manufacture before marketing them for the masses. Failure to adhere to this regulation is negligent and grounds for pharmaceutical lawsuits. The manufacturer of transavaginal mesh did not include warning about the products so that the patients would be aware of the negative effects of the product and make an informed decision. The lawsuits that have been filed accuse the manufacturer of the mesh of giving misleading and insufficient information and training to doctors in order to enhance sales of the mesh.

Some also argue that the manufacturer continued selling the product even after serious side effects were reported. Besides, the manufacturer failed to establish effective and safe methods of getting rid of the mesh. It is because of this why several women and their loved ones have filed transvaginal mesh lawsuit to enable them recover emotional and financial damages. Husbands have also sued the drug manufacturer for loss of consortium since the mesh interferes with the ability of an individual to intimate. People who qualify for a lawsuit against the manufacturer of the product, files the lawsuit under the guidance of a pharmaceutical attorney. The case should also be proved beyond reasonable doubt that the said injuries were as a result of the product and not natural occurrence or due to other products.

Even though many people are aware that filing a transvaginal mesh lawsuit cannot reverse the pain and agony they undergone, the compensation can help them to carter for medical expenses encompassing costs of surgeries, loss of wages, pain and suffering and loss of quality of life. The injuries precipitated with the mesh can also prevent an individual from activities such as walking, sitting. Besides, the emotional and the physical harm can affect relationships, work and daily activities of a woman. For a lot of women, the harm cannot be undone. Several surgeries may be needed to get rid of the mesh and the mesh cannot be entirely removed regardless of the number of surgeries carried out.

Because these transvaginal mesh lawsuit were filed across USA and allegations are the same, several of these cases were transferred by a judicial panel to different federal courts. The cases have been grouped under multidistrict litigation which involves the same claims against a single defendant. Up to now, two women have been hugely compensated. Keep Reading Next

Jury awards $3.35 million in vaginal mesh case against Johnson & Johnson

Read more: Source Fox News



FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Issued: October 20, 2008

Dear Healthcare Practitioner:

This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.

Nature of the Problem Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses. Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

Recommendations

Physicians should:

Obtain specialized training for each mesh placement technique, and be aware of its risks.

Be vigilant for potential adverse events from the mesh, especially erosion and infection.

Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.

Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.

Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).

Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

Source FDA