Monday, January 16, 2012

Transvaginal Mesh Lawsuits: What You Need to Know

If you are a woman who has had a surgery in the past for stress urinary incontinence or pelvic organ prolapse, and you think your surgeon might have used a mesh implant during that surgery, you need to know the facts surrounding the mesh products. While highly similar mesh products have been used in surgical applications for decades—primarily in hernia surgeries—it was not until 1996 that mesh was approved for use in SUI surgeries and 2002 when the mesh was FDA approved for use in POP surgeries. Up until that time surgeons simply adapted the mesh used in hernia surgeries to suit other surgical applications.

Flaws in the Approval Process?

The mesh was able to be implanted into the vaginal wall without the necessity of prior controlled human studies through a sort of governmental loophole known as a 510(k) clearance approval. This type of less-stringent approval process allows a quicker approval without the necessity of clinical trials for medical devices which are substantially equivalent to already-approved devices. What was not anticipated, however, was the differences in pelvic region tissue as opposed to abdominal tissue. The fragile tissues in the pelvic region tend to be much more flexible, therefore the relatively inelastic mesh which works well in the abdomen tends to pull at the surrounding areas and erode through the more delicate tissues.

Mesh Manufacturers on the Hook?

The transvaginal mesh surgeries are performed on as many as 70,000 women each year, leaving these women vulnerable to potential complications. The manufacturers of the mesh implants are currently the target of over 4,000 lawsuits under the belief they sidestepped their legal duty to ensure the mesh products were properly designed, tested and manufactured. Although some consumer advocate groups are calling for a recall of all mesh products when used in implantation in the vaginal wall, the American Congress of Obstetricians and Gynecologists have yet to reach a final conclusion as to whether mesh use in this application should be entirely discontinued. The FDA, while recognizing the risks of vaginal mesh are presently considering several options with an ultimate goal of protecting women from harm. The Journal of Obstetrics & Gynecology published the results of a randomized controlled trial in August of 2010 regarding the use of mesh for pelvic organ prolapse. At three months, there was a 15.6% vaginal mesh erosion rate with “no difference in overall objective and subjective cure rates.”

What are the Complications of Transvaginal Mesh?

While there are other possible factors related to complications from transvaginal mesh implants—smoking, age, menopausal status, the presence of hormone replacement therapy, a woman’s body mass index and whether the woman suffers from diabetes—these factors have not definitively been shown to link directly to the mesh complications. The primary complication suffered by women who have undergone a transvaginal mesh implant is erosion of the mesh into the surrounding vaginal walls or other organs. This mesh erosion can lead to serious infection, bleeding, chronic and severe levels of pain in the back and abdomen, persistent urinary tract infections and pain during intercourse. If a physician determines the mesh has eroded it will be necessary for the patient to undergo one or more surgeries to correct the erosion. In some cases women have required multiple surgeries, and in other cases surgeons are unable to completely alleviate the pain.

More Women Coming Forward

It appears that over 4,000 women have come forward with adverse reports of damage from the transvaginal mesh implant. Because of the nature of the product, it is believed there are many more women who have suffered, but have not come forward because they are uncomfortable discussing problems and complications of this nature. The truth is, this is a problem which impacts literally millions of women. Half of all women who have had children will suffer some level of prolapse over the course of their lives. As many as ten percent of women will require surgery for pelvic organ prolapse, meaning a substantial portion of those were likely subject to the mesh implant. Many women believed their complications had subsided only to have them return, some even worse than they were originally. Women should not have to suffer in silence, and more women are coming forward to speak out against manufacturers who did not give women’s health and futures the proper consideration.

Do You Have a Case?

Lawyers around the nation are filing suits against the manufacturers of the mesh used in POP and SUI surgeries on behalf of women harmed by the device. Many of these women have already suffered subsequent surgeries to remove the mesh from the pelvic tissue and to further treat the complications from the mesh defects. Many more women will require more surgeries in order to regain some semblance of their former quality of life. The majority of the lawsuits which have already been filed are against C.R. Bard and Ethicon which is a Johnson and Johnson subsidiary. If you have had ongoing and severe symptoms of mesh erosion and are facing more surgeries to correct the problem, you likely have specific damages and should consult a reputable, experienced attorney to evaluate your case.

Author: Sullo & Sullo Attorneys

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