Joe's Vaginal Mesh Recall Blog

Vaginal Mesh Lawsuit vs. AMS, Boston Scientific To Proceed, Appellate Court Orders

Posted on Monday, October 28, 2013 by Joe Whistler

Ruling that the plaintiff has detailed a number of factual allegations that when taken as a whole, would suggest that she has indeed suffered injuries as a result of the defendant’s defective products, negligence, and/or unfair or deceptive practices, a Massachusetts Appellate Court ordered the reversal of a dismissal order issued by the Suffolk County Superior Court.

The vaginal mesh lawsuit filed by Billie Allen against American Medical Systems (AMS) and Boston Scientific was earlier dismissed by the lower court stating that the complaint did not meet the necessary pleading standards, prompting the plaintiff to appeal before the Appellate Court.

The plaintiff alleges in her claim that she was implanted with an AMS Perigee Transobturator Repair System and Boston Scientific’s Monarch and Pinnacle mesh implants in 2008 for the repair of her pelvic organ prolapse. A few years after, she started experiencing adverse effects which led to serious injuries requiring multiple revision surgeries.

She contends that her injuries stem from her body’s incompatibility with polypropylene mesh, the material used for the surgical mesh. She asserts that these devices have a history of eroding, causing patients to develop chronic infections, vaginal scarring, severe pain, and other severe complications.

Posted in device, health, lawsuit, news, vaginal mesh, women | Comments Off

Transvaginal Mesh Lawsuit Update: Rottenstein Law Group Responds to Court Order to Remove American Medical Systems as Mesh Defendant

Posted on Wednesday, April 24, 2013 by Joe Whistler

American Medical Systems and other subsidiaries of Endo Pharmaceuticals, Inc. were removed earlier this month as defendants in the federal consolidations of transvaginal mesh lawsuits (MDL-2325, U.S. District Court for the Southern District of West Virginia), according to court documents reviewed by the Rottenstein Law Group, a transvaginal mesh law firm.

A court order* from Chief Judge Joseph R. Goodwin said that “the court will dismiss in all pending cases (whether filed directly or transferred), all claims pending against the Endo entities without prejudice.”

“The removal of those defendants from the multidistrict litigation does not mean that American Medical Systems cannot be sued for the serious alleged side effects of its transvaginal mesh products,” said Rochelle Rottenstein, principal of the Rottenstein Law Group. “What it means is that they won’t be included in the existing MDLs, which is a pretrial consolidation of common causes and acts of discovery.”

Read full story at PRWeb.com: Transvaginal Mesh Lawsuit Update: Rottenstein Law Group Responds to Court Order to Remove American Medical Systems as Mesh Defendant

Posted in health, implants, news, vaginal mesh, women | Comments Off

Vaginal Mesh Safety

Posted on Monday, October 1, 2012 by Joe Whistler

Pelvic organ prolapse is a condition in which the vaginal floor has incurred damage and may no longer support the pelvic organs. It is because of the damaged pelvic walls, from which the pelvic organs may protrude into the vagina or even all the way to the vaginal opening. Although in this medical condition, it may also be possible to have more than one organ prolapse yet this is not always the case. One of the more popular methods of treating a pelvic organ prolapse is by undergoing a vaginal mesh implant and it is very important to identify what vaginal mesh you are using.

A transvaginal mesh (TVM) is the key to any vaginal mesh surgery. It may be used in a pelvic organ prolapse repair surgery or in a stress urinary incontinent repair procedure. The mesh will be required to enter the vagina during a pelvic organ prolapse surgery. After the mesh has been situated into the pelvic area, it may then be permanently set into place by stitching it onto the surrounding vaginal walls.

According to the Update on Safety and Effectiveness of the Food and Drug Administration (FDA), in terms of a vaginal mesh in treatment of POP, their review has shown that there is not enough evidence to suggest that a transvaginal mesh is better than traditional procedures. This statement may be due to the lack of assessments in the long-term perspective. Additionally, since a vaginal mesh procedure is often recommended to patients with pronounced prolapse issues, there might not be a more level basis for comparison.

The FDA may have been lacking data on the effectiveness of a vaginal mesh implant as compared to traditional methods. Yet they were not lacking data as to its safety. As a matter of fact, the FDA was able to compile more than one thousand reports in 2008 while the complaints filed in 2011 nearly reached four thousand.

The FDA has shown that vaginal mesh complications may lessen its safety. Knowing more about it in a vaginal mesh lawsuit reports may constitute the best advice. Bowel perforation, vaginal shrinking or scarring, urinary incontinence, recurrent prolapse, emotional problems and neuro-muscular problems are also some of the other complications that may arise after a surgery.

Sources:
fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
webmd.com/urinary-incontinence-oab/news/20110713/fda-surgical-mesh-for-pelvic-prolapse-risky-unnecessary

Posted in attorney, legal, mesh implants, prolapse, surgical mesh lawsuit, transvaginal mesh lawsuits, vaginal mesh, vaginal mesh lawsuit, vaginal mesh lawsuits, womens health | 1 Comment

Public Citizen Petitions the Removal of Trans-vaginal Mesh from the Market

Posted on Friday, December 23, 2011 by Joe Whistler

Trans-vaginal mesh (TVM) surgery has been well-known for quite some time until numerous complaints of its deadly complications surfaced and made a commotion in the public recently. Filed lawsuits against this procedure are piling up as the population of discontented recipients keep growing.

The implantation of trans-vaginal mesh (TVM) is practiced for the clinical repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). These medical conditions affect many adult women in all sides of the world. With this, more and more women are exposed to TVM surgery. This means that many more women are subjected to TVM procedure.

An announcement was made by the U.S. Food and Drug Administration (FDA) in 2008 covering the complications posed by TVM surgery; and investigations on the reclassification of the vaginal mesh and the need for regulatory changes like the availability of studies directing the advantages and negative effects of this medical device were also being considered by the agency. The U.S. Food and Drug Administration warned the public of the deadly consequences associated with this procedure in 2008, and has been doing investigations on the risks and benefits of TVM and the possibility of reclassifying this medical device.

What happens during a recall?

A recall takes place when the FDA receives reports from either medical professionals or patients of detrimental reactions of a drug or medical device and removes this particular device from the market. The recall of a medical device or a drug from the market must be justified by the tendency of it causing serious injuries or even death.

How is a recall classified by the FDA? How does FDA classify recalls?

The FDA sorts recalls into 3 categories. Category I are recalls classified to cause serious complications or mortality. Recalls sorted as category II are those products that may cause reversible adverse effects. In category III recalls, products are not frequently related to serious health complications. After a recall is accomplished, the FDA ascertains that the recalled products are destroyed and appropriately reconditioned.

Why are vaginal mesh products necessary to be recalled?

In October 25, 2011, a consumer advocacy group called Public Citizen submitted an appeal to the FDA that all non-absorbable vaginal mesh be recalled. They stressed that there is a need for these non-absorbable vaginal meshes to be removed from the market since it’s benefits over other non-mesh procedures used to repair POP and SUI were unseen, and patients who received them developed fatal reactions. The group also recommends that all non-absorbable vaginal mesh be tested appropriately for safety and effectiveness before the FDA approves its availability in the market.

It is not clear when the FDA will make a decision about this request, but it is currently doing investigations on the surgical meshes involved with all the reported complications. The FDA is also planning to broaden the scope of device performance monitoring. To understand the risks caused by TVM procedure, the FDA is asking help from health professionals and involved patients to participate in this investigation by reporting negative reactions.