Transvaginal Mesh Patch – Failure to Test

(May 15, 2012) – Transvaginal meshes are implantable devices, produced by several manufacturers for the treatment of pelvic organ prolapse (POP). This is a condition that usually occurs following childbirth. The meshes are made of plastic and are used with stitches to help support the organs in the pelvic region. They have been found to cause severe pain and dangerous side effects.

In many cases, the mesh devices must be surgically removed. However, in rare cases, removal is not possible, due to development of scar tissue, causing increased suffering to these women.

Transvaginal mesh devices are manufactured by American Medical Systems, Bard, Johnson & Johnson, as well as Boston Scientific, and have led to negative side effects. Symptoms associated with these injuries are:

–       Erosion of the vaginal mesh
–       Vaginal scarring
–       infection
–       urinary problems
–       painful sexual intercourse
–       pain
–       bleeding
–       additional “revision” surgeries

Johnson & Johnson (J&J) sold the Gynecare Prolift mesh device in 2005 without FDA permission, and did not receive FDA approval until May 2008.  J&J did not bother to take the Prolift through the device approval process, deciding on its own that the mesh was similar enough to current devices to skip its own approval process. An FDA spokesperson stated that the FDA “disagreed with this assertion.”

J&J faces at least 550 Prolift lawsuits. It is believed that due to these unapproved sales, J&J will be forced to pay out even more to resolve lawsuits, a much-deserved benefit by victims of Prolift.

The president of Consumer Reports has spoken out against the FDA approval process that allowed devices such as transvaginal mesh to be used in patients without full regulatory scrutiny. In an email sent to more than one million recipients, Jim Guest called the approval process “a nightmare scenario.”

Guest claims that the regulatory process which manufacturers use to get approval for surgical mesh and other devices without human safety trials has led to recalls of 700 different products each year. Consumer Union – the advocacy arm of Consumer Reports – has said it will make its campaign to change the approval process a top priority.

Transvaginal mesh has been the subject of major recalls by manufacturers such as Johnson & Johnson and Boston Scientific. Patients who received the device have complained of device failure, leading to severe tissue damage, pain, limited mobility and pelvic organ prolapse.

In the past three years, the FDA has received over 1,500 reports of complications with surgical mesh devices used to repair POP, and over 650 patients have filed vaginal mesh lawsuits. During this time there were seven reported deaths associated with POP repairs, three of which were related to the mesh placement procedure.

Medical device manufacturer C.R. Bard will face the first of hundreds of transvaginal mesh lawsuits in a federal court beginning in 2013. The lawsuit alleges the Bard’s transvaginal surgical mesh device failed and caused organ damage.

More than 75,000 women receive a transvaginal mesh device every year to treat pelvic organ prolapse, stress incontinence, or similar pelvic issues. Many of the devices, some of which have been passed without clinical trials, have been found to fail a higher rates than expected, leading to complications, including severe pain and in some cases, the need for repeat surgery.

Have you been adversely affected by a transvaginal mesh patch? If you do not feel comfortable leaving comments about your experience on this blogpost, you may contact us at 1-800-246-HURT (4878).

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