The Flood of Vaginal Mesh Suits Points to a Faulty Product Assessment

Bladder ProlapseWell-known health product manufacturers nowadays are facing vaginal mesh lawsuits after claiming that the mesh items they designed are “substantially equivalent” to formerly approved meshes that have recently been recalled, industry observers say. These exposed dangers of vaginal mesh have nowpermeated the mainstream media.

The introduction of these flawed items to medical consumers has cut through all the red tape by going under an approval system known as the 510 (k) process. This method, which was created and managed by the U.S. Food and Drug Administration (FDA), has gained consistently negative reviews from medical practitioners, individual patients, and even women support groups. Criticism such as this may had been expected from the public since the federal product evaluation regimen did not test products on actual patients. For products to be approved and marketed, they only have to show similarities with any of the items that have gained market approval in the past. There were some patients and a few advocacy organizations which believed that this evaluation process by the FDA is partly to blame for the surge of complications experienced by patients who opted to receive these types of implants.

Vaginal mesh implants, slings, and its kits are uncontrollably and recklessly used in primary health clinics for women patients in the US. These are surgically implanted during a minimally invasive procedure through the vaginal opening. Devices such as these are intended for the anatomical correction of slipped pelvic organs (otherwise known as pelvic organ prolapse) and stress urinary incontinence, a condition in which a small amount of urine leaks from the bladder due to sudden pressure in the pelvic and abdominal area (often triggered by sneezing, coughing, laughing, and during exercises).

Boston Scientific Corporation’s Protegen mesh implant is the only type of implant that has ever been recalled by the FDA after recipients complained of a rising number of complications. After these products were pulled from the market, it was unbelievable how other products with the same material and use as this type of mesh remained in the medical market for public use. Following the recall of Protegen, several other mesh products were also reported by many patients who received them to be causing complications that they believe are associated with the material and design. Because of the vagueness of the side effects, and the lack of medical explanation as to how these complications may have occurred, the FDA is unsure which action to take. However, to answer back to the appeals made by concerned groups and individuals, the agency has been conducting reviews and further researches on the nature of the complications and finding ways to determine whether they are related to the mesh products that have been utilized.

Until now, the vaginal mesh implants available in the market are still continuously distributed for surgical use throughout the gynecology facilities worldwide. Moreover, the 510 (k) process is still used to grant marketing clearances to most of the medical devices. This faulty product evaluation process has been pointed out by many to be the reason for the flood of vaginal mesh lawsuit claims that had been swept into the United States.

References:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm262299.htm
http://www.bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html
http://www.webwire.com/ViewPressRel.asp?aId=154797

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Every Woman is at Risk for Prolapsed Bladder?

As more reports about product failures filtered from mainstream, the American public was surprised and worried about the complications arising from the use of synthetic mesh in the treatment of pelvic organ prolapse (POP). This prompted the U.S. Food and Drug Administration (FDA) to recommend treatments for vaginal mesh failure.

The front wall of the vagina provides support to the bladder, so these two structures affect each other. As the body matures, the vaginal wall may loosen, causing the bladder to fall down or prolapse into the female reproductive organ. This simple shift may lead to unimaginably bothering symptoms, such as pelvic pain and urinary incontinence prompted by even the slightest movement.

Bladder prolapse can be subdivided into four categories and this is based on the extent of thecase at hand. Grade one prolapse occurs when only a small and sometimes unnoticeable part of the bladder extends into the female genitalia. This is the mildest type and the symptom that may be manifested by the patient is the occasional urinary incontinence. In most cases, this is even asymptomatic.

In grade two prolapse, the bladder has shifted into the vaginal opening. Compared to grade one prolapse, this type involves noticeable symptoms like dyspareunia (pain during sexual intercourse), more defined urinary incontinence, and painful urination. With prolonged standing and sitting, this type of prolapsed bladder may be exacerbated.

A grade three prolapse is categorized as severe bladder prolapse since part of the bladder can be easily visualized bulging out from the female reproductive organ. Also, this is associated with pelvic and vaginal pain, especially in the presence of strenuous activities. Also, sitting down can be a nightmare since part of the bladder is exposed outside. Patients with this level of bladder prolapse are at risk for infections as well.

Grade four prolapse is considered complete bladder prolapse as this is characterized by the protrusion of the entire bladder from the female genitalia. This type necessitates immediate surgery since total exposure of the bladder may cause it to rupture or be exposed to massive infections. Complete bladder prolapse may also indicate the presence of any of the other types of pelvic organ prolapse.

Vaginal Mesh Lawsuit MDL

Apart from pregnancy, childbirth, past hysterectomies, and other pelvic surgeries, bladder prolapse may also be triggered by chronic cough or bowel problems, like constipation. With this, almost every woman is at risk.

A prolapsed bladder is only one among the different kinds of pelvic organ prolapse (POP) that women advancing in years are most concerned about these days. The use of synthetic mesh being the latest medical discovery for POP has been increasingly advocated by patients and physicians alike, even when it also has led to the filings of vaginal mesh lawsuit against companies that manufactured them.

References:
http://www.emedicinehealth.com/prolapsed_bladder/article_em.htm
http://bladder-problems.org/
http://www.urologyhealth.org/urology/index.cfm?article=118

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Over a thousand complaints filed at FDA against transvaginal mesh

The U.S. Food and Drug Administration (FDA) told all physicians regarding the severe problems linked with the transvaginal placement of surgical mesh for the surgery of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) according to the FDA website reports.

This surgical mesh is used in women for the treatment of pelvic prolapse, bladder prolapse, and other similar or related problems. It is put in the vagina which serve as a pelvic or bladder sling and reinforcing the vaginal wall.

Over the past three years, FDA has received over 1,000 reports against nine surgical mesh manufacturers documenting complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are regularly located transvaginally make use of utensils for nominally hostile post.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse or incontinence. There were also news about bowel, bladder, and blood vessel damage thru insertion. In some cases, vaginal blemishing and mesh attrition led to an alarming lesser quality of life in the patients because of discomfort and pain which has included dyspareunia as the FDA says.

The treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), intravenous therapy, blood transfusions, and drainage of hematomas or abscesses, says the FDA website.
Specific characteristics of patients facing an increased risk for the complications have not been determined, according to research findings. Those contributing causes 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.

To prevent problems, health provider should undergo specialized training for each mesh placement technique and should be knowledgeable enough according to FDA recommendations. Doctors are being told to be watchful over possible adversative actions from the mesh, particularly attrition and infection. They are also requested to guard for snags related with the utensils used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
In particular, physicians were to notify patients that the implant of surgical mesh is lasting, and that some problems associated with the implanted mesh may entail extra surgery that may or may not precise the complication, the FDA reported.
http://wordpress.com/
http://www.medscape.com/viewarticle/746285
http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976

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