Are You Thinking About Applying For a Lawsuit Settlement Advance On Your Bladder Mesh Litigation? If So, You Simply Must Check This Out First.
Transvaginal Mesh Lawsuits
Bladder sling devices were created to correct Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Thousands of complaints and lawsuits have been filed and countless studies and reports have been done that draw attention to the complications that have been discovered since mesh implants have come into widespread use. Two common side effects are organ perforation and erosion.
Many women have sought compensation for the physical suffering and emotional toll that they must endure resulting from these side effects. The complications are not easily treated since they require multiple surgeries, sometimes as many as five or more surgeries in order to correct the damage that was done, and that’s assuming it can be fixed at all. Some unfortunate women have experienced such terrible side effects that any sort of corrective surgery at all would be life-threatening or even deadly and is therefore out of the question and thus, they must suffer with this worsening condition for the rest of their lives.
Many of the manufacturers that make mesh implants, who have consistently denied any liability are now faced with tens of millions of dollars worth of individual and class action lawsuits. Of the tens of thousands of women that have filed lawsuits in both state and federal courts so far, some have settled while others have gone to trial, been decided by a jury and have received favorable verdicts – one verdict so far has been $100 million!
By mid-2014, almost 50,000 women had filed litigation against the various vaginal mesh manufacturers because of severe injuries resulting from their products.
Historically speaking, bladder sling litigation can typically take between 2 and 5 years to settle, sometimes more. Many women have experienced moderate to severe financial trouble during this time as many are often unable to work during or after getting revision surgeries wherein they attempt to remove or modify the mesh.
Lawsuit funding companies like TriMark Legal Funding LLC offer non-recourse pre settlement funding and lawsuit cash advances from $1,000 up to $50,000 on qualified vaginal mesh and bladder sling lawsuits nationwide.
What is Transvaginal Mesh?
A bladder sling is a net-like surgically-implantable material that is used primarily to treat pelvic organ prolapse and stress urinary incontinence in women. Transvaginal mesh devices got their name as a result of the surgical procedure that is used to implant the device, which basically means “through the vagina”.
The dimensions of the mesh varies depending on the patient’s needs, as well as the organs involved. The mesh may be put on the front, top or back wall of the vagina. Vaginal mesh implantation procedures are usually performed transvaginally; in fact, 3 out of every 4 procedures in 2010 were performed this way.
POP and SUI are conditions that occur in women usually after child birth, hysterectomies or menopause.
POP is a condition wherein pelvic muscles become weakened and pelvic organs (usually the rectum, bowel, bladder and uterus) drop into the vaginal canal. The transvaginal mesh acts like a hammock to hold the organs up where they belong. To accomplish this, surgical mesh is implanted either transvaginally or abdominally.
SUI is diagnosed when the bladder leaks urine during times of increased physical activity, or via any activity that increases pressure on the bladder. For this condition, the mesh device supports the urethra when the pelvic muscles weaken. The bladder sling, as it is commonly called, or vaginal tape, is the most common surgical material used to correct the condition.
FDA Warnings, Reports and Recall
The FDA has issued warnings for patients with SUI that any surgery to treat this condition can endanger the patient because of risky complications that may occur, possibly even requiring additional surgery. One possible complication that may arise from surgeries to treat SUI is vaginal mesh erosion, particularly when using mesh slings. When this complication occurs, the patient may possibly need to go through more or more surgeries to repair the erosion, assuming it is repairable.
The FDA also advises patients who have undergone surgery to treat SUI to have yearly check-ups and care post-surgery. The FDA also advises these patients to seek professional medical help if and when further side effects arise like persistent vaginal bleeding or discharge, pelvic or groin pain or pain during sexual intercourse.
It was in July 2011 that the FDA provided updated safety communication about serious problems associated with transvaginal mesh devices to treat POP. This included the discussion of how the devices cause serious complications and that these are not rare. It was also stated in the memo that it was still unclear if transvaginal POP repairs using mesh devices are more effective than that of traditional repair, without using mesh devices. In this review, the October 2008 FDA Public Health Notification was also mentioned, further supporting the claims of vaginal mesh devices having severe health and effectiveness issues.
The Obstetrics and Gynecology Devices Panel of the FDA recommended in September 2011 that these surgical mesh devices (for POP) be moved to class III from class II, and require premarket approval (PMA). Back in January 2012, the FDA also ordered manufacturers of surgical mesh devices to conduct postmarket surveillance studies, to handle concerns regarding specific safety and effectiveness related to the device with respect to usage for transvaginal repair of POP. After the issuance of the post-market surveillance study orders, some manufacturers of surgical mesh devices voluntary recalled and withdrew their products to be sold in the market.
In April of 2014, the FDA had a news release with the institution submitting proposals to tackle the issue of risks associated with surgical transvaginal mesh to repair POP. In short, the FDA has concluded the clear risks involved with vaginal mesh to repair pelvic organ prolapse and are moving to address the risks for more safe and effective products.
FDA is suggesting that instruments used for surgical vaginal mesh devices be moved to a different classification, from class I (low-risk devices) to class II (moderate-risk devices), while also proposing to reclassify surgical mesh devices used for POP treatment from class II to class III (high-risk device). These proposals, however, do not include surgical mesh indicated for surgical treatments of SUI, abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications.
Vaginal Mesh Post-Surgery Complications
While post-surgery complications can vary from severe bleeding to infection to synthetic mesh cutting through vaginal walls, most claims that were filed against mesh device manufacturers were because of erosion and organ perforation complications post-surgery.
Erosion is a process wherein the transvaginal mesh erodes through the female body’s soft internal tissues. As one might imagine, this is an extremely painful complication that may also result in extrusion or protrusion – meaning the mesh can be seen externally. Vaginal erosion can make sexual intercourse extremely painful, sometimes making intercourse unbearable. Urinary tract infections may also arise, and are often recurrent or chronic infections until the mesh is removed.
In most situations, removing the mesh is the only solution to erosion; however, it is not always possible.
Doctors used the metaphor of cutting gum out of hair as a comparison for removing eroded mesh.
Organ perforation is the infiltration of the wall of a hollow organ in the body. Because the mesh erodes through tissues, it has the possibility of puncturing the organs. The bladder is the most commonly perforated organ but it also usually affects the urethra, bowel, or rectum.
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