Vaginal Mesh Defects And Recalls
Many women have undergone a procedure to correct pelvic organ prolapse, pelvic floor repair, or stress urinary incontinence. Transvaginal mesh is surgically implanted into the vaginal wall in order to keep the pelvic organs in place. However, this product has and continues to expose women to complications that are very serious. They are so serious that they can be life threatening.
Between 1996 and 2008, a number of manufacturers were given clearance by the FDA to use vaginal mesh to correct the aforementioned pelvic organ issues. They were given this clearance because of the success the mesh had had when used in other parts of the body. The issue when used as transvaginal mesh is the fact that the mesh was never tested in transvaginal procedures. This resulted in complications being seen as early as 1999. That was when the first recall of 20,000 implants was issued by Boston Scientific. Despite the recall, the FDA continued to approve products very similar to those that were recalled.
It was October 2008 when the FDA issued a health alert that warned doctors about the transvaginal mesh risks. At that time, however, the FDA stated that the issues with transvaginal mesh were quite rare. This was followed by a rise in transvaginal mesh lawsuits because so many women started to experience health problems. Between 2008 and 2010, there were 2,800 reports of transvaginal mesh complications reported to the FDA. This resulted by a warning in 2011 by the FDA that the probability of complications was rising. The FDA noted that the complications were not limited to just one brand. In fact, many brands were seeing these complications.
In September 2011, the FDA advisory panel recommended that these mesh products be reclassified as high risk. This would force the manufacturers to undergo very strict testing so they could receive FDA approval. All-in-all, the FDA reached out to a total of 35 vaginal mesh manufacturers regarding the safety of their products. Nonetheless, there are still many women out there with the original implants, experiencing difficulties. Through legal action, it is possible to have the issue correct with no cost to the patient.
Getting Help From A Vaginal Mesh Lawyer
The issues that can arise from vaginal mesh include erosion of the implant, infection, urinary issues, painful intercourse, and the recurrence of stress urinary incontinence or pelvic organ prolapse. There have been a number of class action lawsuits brought against the manufacturers. The purpose of the lawsuits is to compensate the victims for their suffering, but to also make sure the implant is removed and a better solution put in place, whether through an approved mesh implant or another method. Unfortunately, these corrective procedures can be painful because of the damage the mesh has done. Nonetheless, life can get back to normal.
Call Today For A Free Consultation
TSR Injury Law wants to help you. Many women have experienced injury and some have even died from faulty vaginal mesh. If you are a victim or the loved one of a victim, call us at 612-TSR-TIME and we will discuss your rights and options with you.