June 2012 Mesh News: FDA Didn’t Approve Vaginal Mesh Products?

It's being reported that  vidence has surfaced that indicates that device manufacturer Johnson & Johnson did not have Food and Drug Administration approval for the transvaginal mesh product they were selling for three years.

men have already been wounded by vaginal mesh devices that have caused serious complications for them. According to a report by Bloomberg.com, the device manufacturer began selling the Gynecare Prolift vaginal mesh device in March of 2005, which was 3 years  before the device was approved by theFDA. Between the time it was released on the market until it was approved, the FDA received 123 reports of complications associated with the Gynecare Prolift device.




Vaginal mesh devices are ways of treating stress urinary incontinence and pelvic organ prolapse, which are both conditions dealing with the weakening of pelvic organs. Complications associated with the devices, however, can cause even further problems, including recurrence of the original problems, urinary tract infections, and mesh erosion. Hundreds of women—more than 550—have filed lawsuits after suffering from transvaginal mesh complications. They are hoping to gain compensation that would help cover medical bills they have incurred due to their side effects.

The Food and Drug Administration reported a fivefold increase in complications associated with vaginal mesh devices, including deaths and malfunctions, in July of 2011. This decision resulted in an advisory panel for the organization recommending that such devices should be reclassified as “high risk” devices that are in need of human testing before it can be determined whether or not they are safe.
FDA process questioned.

Read more here:  http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

GA March 23, 2012 Mesh News: Prolift Pelvic Mesh Product Sold For Over 3 Years Without Necessary FDA Clearance

 Read more: http://www.timesunion.com/business/press-releases/article/FDA-Confirms-Johnson-Johnson-Prolift-Pelvic-3426909.php#ixzz1q5Io0Rjv




The FDA confirmed in a March 16, 2012 communication released to Bloomberg News that the vaginally placed pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc. since March, 2005, was initially marketed without any clearance or approval from the FDA. Ethicon attempted to justify this decision, claiming the Prolift, a vaginal mesh medical device for treatment of pelvic organ prolapse, was legally marketed pursuant to the 510K for a significantly different product.In the March 16, 2012 communication, FDA spokesperson Morgan Liscinsky stated that the: “FDA disagreed with this assertion.” The FDA statement unequivocally rejects Ethicon’s contention that the Prolift was legally marketed under the 2002 clearance provided to the other device known as Gynemesh PS.

Read more: http://www.timesunion.com/business/press-releases/article/FDA-Confirms-Johnson-Johnson-Prolift-Pelvic-3426909.php#ixzz1q5J7lsqi 

March 15, 2012 GA Mesh News

Many folks are seeing the term "POP" when they hear about mesh and mesh implants failing. Pelvic Organ Prolapse is commonly called POP - P is the condition that results when the normal supporting structures of the vagina deteriorate.

The resultant support loss can cause any or all of the following structures to prolapse (drop out of
position): urethra, bladder, bowel, and/or cervix/ uterus/ vaginal vault. This prolapse can produce
such symptoms as a sensation of bulge, difficulty with bowel or bladder function, pain and/ or
dyspareunia (painful intercourse).  Traditional treatment options for POP include hysterectomy,
colporrhaphy (plication of pubocervical or rectovaginal fascia), sacro-colpopexy (suturing of
vaginal apex to the sacral promontory using either mesh or fascial bridge) performed either
abdominally or laparoscopically and sacrospinous fixation (securing the vaginal apex to the
sacrospinous ligament).  Mesh products were introduced as supporting materials in the surgical
treatment of POP to address the high levels of recurrence rates associated with traditional repairs
using the patient’s own tissue,.


In July 2011, the Food and Drug Administration (FDA) issued an updated safety notification
concerning the safety and effectiveness of transvaginal surgical mesh devices for POP repair and
a White Paper titled, Urogynecologic Surgical Mesh:  Update on the Safety and Effectiveness of
Transvaginal Placement for Pelvic Organ Prolapse.

 While the 2011 notification references similar kinds of complications as had been reported in FDA’s 2008 notification, FDA changed its prior assessment of the frequency of adverse events (AEs) associated with these devices, and identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

Based on its updated assessment, FDA is considering changes to the regulation of transvaginal
mesh products, such as reclassification from Class II to Class III or additional pre-market and
post-market regulatory requirements.

Read more on the FDA site: http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

Transvaginal Mesh Lawsuit Update (February 1, 2012)

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Last week the JPML heard arguments regarding centralizing litigation involving mesh implants. 

The Court heard argument on motions filed on behalf of women who claim to have suffered injuries after being implanted with vaginal mesh products for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The plaintiffs are asking for the JPML to create separate multidistrict litigation (MDL) cases against three different transvaginal mesh manufacturers: American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326) and Ethicon, Inc. (MDL No. 2327).

By pulling together lawsuits that have been filed in federal district courts across the country for pretrial proceedings, the MDLs would make the litigation more efficient, conserve judicial resources and avoid the risk of inconsistent rulings, the plaintiffs argue.

The plaintiffs also are requesting that the cases be transferred to the U.S. District Court for the Southern District of West Virginia and that they be supervised by Chief Judge Joseph R. Goodwin, who currently is overseeing the MDL against another transvaginal mesh manufacturer, C.R. Bard, Inc. (In re Avaulta Pelvic Support Systems Product Liability Litigation, MDL No. 2187)

I expect a decision by 2/15/12. 

Report on Transvagainal Mesh Failures

From MSNBC, a report on the failure of mesh implants


100,000 mesh patients in 2010 In 2010, the agency says, doctors performed at least 100,000 prolapse repairs using surgical mesh, and about three-quarters of them were transvaginal. From 2005 to 2007, the FDA received more than 1,000 reports of adverse events related to the mesh in women treated for pelvic organ prolapse or stress urinary incontinence. From 2008, when the FDA first revealed its safety concerns, to 2010, the agency received nearly 3,000 more.

Read more here.http://www.msnbc.msn.com/id/43886793/ns/health-health_care/#.TpraaHJu5Rw