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New Court Order Lists Vaginal Mesh Trial Dates for West Virginia MDL

Posted by transvaginalmeshlawsuit on October 17, 2013 at 12:50 AM

A new set of schedules for the trials of the vaginal mesh lawsuits under the multidistrict litigation (MDL) was released by Judge Joseph Goodwin of the US District Court for the Southern District of West Virginia in a court order released on October 9, 2014. This new schedule is very significant since it now includes all major manufacturers including Boston Scientific with its first bellwether trial scheduled for early 2014. Changes involving the other defendants in the MDL were also included in the court order, as follows:

 

American Medical System

Originally set for December 3, 2013, the first bellwether case for American Medical Systems has been moved to April 7 next year. This postponement may be understandable in view of the settlement of selected lawsuits made earlier this year. To recall, Endo Health Solutions, the parent company of American Medical System, agreed to set aside $55 million for the resolution of a number of claims.


This development may have also affected the choice of lawsuits to represent as bellwether cases. It has been decided by the court that the determination of bellwether cases will be made in December this year. The second bellwether case for American Medical Systems has been set for May 5, 2014. The schedule for the rest of the bellwether cases still has to be finalized by the court.


Ethicon, Inc.

The first bellwether case for Ethicon MDL will still be that of Carolyn Lewis but instead of January 14, 2014, the date for the trial has been moved to February 10, 2014. The second trial has been scheduled on June 23, 2014 on the lawsuit of Jo Huskey. In an earlier order, the second bellwether would have been heard on May 27, 2014 for the claim brought by Judy Brown. Should any of these lawsuits be settled or removed for whatever reason, it will take on the lawsuit of Tonya Edwards against Ethicon.


C.R. Bard

Notwithstanding the settlement by C.R. Bard of the second bellwether case, the third vaginal mesh lawsuit has been lined up by Judge Goodwin. Instead of a November trial date, the third bellwether case will start on December 03, 2013 and will take on the vaginal mesh lawsuit filed by Carolyn Jones.


Coloplast and Cook Medical

As of the last conference held by the court, no bellwether trials have been scheduled for both Coloplast and Cook Medical. It is hoped that trials involving these two mesh manufacturers may also be scheduled by early next year.


Although trial dates have been scheduled, some sectors are optimistic that claims of vaginal mesh victims may be settled before these dates. Already, there have been claims settled by certain manufactures and negotiations for settlement have also been reported in online media sources. These developments should provide encouragement to those who have submitted claims and to those who still have to take legal actions for their vaginal mesh injuries.


Reference:

  • wvsd.uscourts.gov

 

Materials Used in Prolift Vaginal Mesh Unsafe, Researcher Testifies

Posted by transvaginalmeshlawsuit on May 8, 2013 at 11:00 AM

Scientists involved in the development of the Prolift vaginal mesh tried to convince key executives of Ethicon to use a different type of material which they believed was a lot safer than the mesh used in the Gynecare Prolift.


Gene Krammerer, a principal scientist in the development of the Prolift testified before the court during the trial of Linda Gross versus Ethicon that he and other researchers tried to persuade company officials to use the UltraPro mesh for the Prolift vaginal mesh which was larger and had larger pores. They strongly believed that these characteristics of the UltraPro mesh will lead to fewer complications when implanted on patients suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI).


Even with the strong recommendations of the R & D group, Johnson and Johnson proceeded with the launching of the Gynecare Prolift in 2005 with the original materials. A year after, Linda Gross was implanted with this device in connection with her hysterectomy procedure. She has been suffering severe complications ever since her operation which has led her to file a liability lawsuit against Ethicon.


Read More: J&J Execs Knew Vaginal Mesh Was Dangerous, Trial Witnesses Say

Another Vaginal Mesh Lawsuit

Posted by transvaginalmeshlawsuit on August 1, 2012 at 2:50 PM Comments comments (0)

Pains, infections, and vaginal bleeding are experienced by people who went through the pains of pelvic organ prolapse and stress urinary incontinence and who were implanted with a vaginal mesh. These must be blamed more often on the defective vaginal meshes produced and sold in the market. For this reason the controversial vaginal mesh lawsuit is inevitable.

 

Recently, a woman from New York filed a lawsuit against American Medical Systems, Inc. because she reported going through symptoms associated with a defective vaginal mesh. This lawsuit has now became part of the ongoing multidistrict litigation in U.S. District Court for the Southern District of West Virgina.

 

Read more: New York Woman Files Lawsuit Against Vaginal Mesh Manufacturer American Medical Systems

FDA Asking Mesh Companies to Conduct New Safety Studies

Posted by transvaginalmeshlawsuit on July 24, 2012 at 12:20 AM Comments comments (0)

In October of 2008, the United States Food and Drug Administration (FDA) released a warning regarding the serious side effects and other complications that were related to surgical mesh placed through the vagina to treat POP and SUI. Now, after additional study has been conducted, the FDA issued an update warning physicians and patients alike that the serious complications linked with transvaginal placement of surgical mesh are not rare. Additionally, the study concluded that it is not clear whether transvaginal POP repairs using mesh is more effective than other, non-mesh utilizing repairs in patients with POP, and the mesh may expose great risks to patients. Many of these patients have begun to file lawsuits against multiple vaginal mesh companies.


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

Patients who have had transvaginal mesh surgery may experience common side effects such as: Painful urination, discomfort during sex, erosion of the transvaginal mesh, tightening of the vagina, and possible scarring of the vaginal tissue.


Because of the increase in complaints the FDA on January 4, 2012 ordered Johnson & Johnson, C.R. Bard, Boston Scientific, and 30 other manufacturers of surgical mesh to conduct new studies on the safety and effectiveness of vaginal mesh when used to treat pelvic organ prolapse and stress urinary incontinence. The FDA letter follows on a recommendation from an FDA advisory panel in September 2011 that mesh for pelvic organ prolapse be reclassified as a high-risk medical device. The FDA claims that "The FDA's order reflects increasing reports of serious injuries caused by certain vaginal mesh products, and manufacturers have marketed these products heavily without conducting adequate human studies or providing adequate risk information,"


The FDA also claims that if you are a recipient of a transvaginal mesh implant and you have begun to show the common side effects to consult with a doctor as soon as possible.


References:

prweb.com/releases/2012/6/prweb9592863.htm

Pelvic Floor Muscles Weakened During Pregnancy

Posted by transvaginalmeshlawsuit on March 21, 2012 at 3:55 PM Comments comments (0)

Vaginal Mesh Infographic

Pregnant women need to find out about how strong their pelvic floor actually is. This is to reduce the risk of developing a form of prolapse disorder and to completely avoid unpleasant treatments or any invasive pelvic organ prolapse surgery.


Some doctors say that prolapse is not evident in pregnant women who have never delivered a child vaginally. But, whether a woman is carrying her first baby, or has delivered through a planned Cesarean section before, she is just as prone to having prolapse as those who had previous vaginal births, experts say.


In vaginal deliveries, the impact of the baby’s head on the floor of the pelvis causes the pelvic muscles to stretch and weaken. This is the most common reason for prolapse borne from vaginal births. In a different way, prolapse may also occur during the time of pregnancy as hormones progesterone and relaxin (which are at high levels during pregnancy) cause smooth muscle relaxation. With this, the smooth muscles that make up the pelvic floor need more strength to suspend the growing uterus and the rest of the pelvic organs that lie over it. As the fetus matures inside the womb, the pelvic floor is even more exposed to pressure.


After the baby has been delivered either vaginally or by Cesarean method, the sudden plunge of estrogen levels cause the smooth muscles of the bladder sphincters to lose its tone, leading to incontinence. At the same time, the pelvic muscles are further stretched as lactation also decreases the level of body estrogen. It may only resume to its normal limits when the mother stops breastfeeding.


During these times, it is important for women to do strengthening muscle exercises and keep a balanced diet to avoid gaining too much weight. Also, constipation tendencies need to be corrected because full bowels press on the vaginal wall and the pelvis as well. In addition to this, having enough rest and avoiding prolonged exercises that put strain on the pelvic floor may help keep the pelvic muscles strong and fit to provide a better support and stability for the pelvic organs.


Most women have relied on the use of transvaginal mesh to surgically correct prolapse problems they have acquired from pregnancy and childbirth. This has provided some with the quickest and the most effective solutions for their symptoms. However, others gained nothing out of this other than the painful and embarrassing complications that led them to file for a vaginal mesh lawsuit. They never would have gone through this sore process had they known that it may be prevented beforehand.


References:


www.babycentre.co.uk/baby/youafterthebirth/pelvicfloor/

www.childbirthconnection.org/article.asp?ck=10206

www.wellsphere.com/pregnancy-fertility-article/the-pelvic-floor-prolapse-and-pregnancy/1515417

thepregnancycentre.com.au/post-pregnancy/tips/about-prolapse

www.livestrong.com/article/149469-adverse-effects-of-progesterone/

Thousands of TVM Lawsuits Continue to Increase

Posted by transvaginalmeshlawsuit on December 27, 2011 at 11:45 AM Comments comments (0)

A medical device called trans-vaginal mesh (TVM) also known for its other names: bladder sling or pelvic mesh, has been utilized as an implant to support the vaginal wall in the management of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mostly affected by POP and SUI are old women of menopausal age and those who had their uterus removed in the past; but many young women who had a history of childbirth had also developed these ailments.

 

Initially, TVM procedures made a positive impact on women’s lives as symptoms were recorded to have disappeared after the surgery. Unfortunately in recent years, increasing reports of negative events resulting from the use of vaginal mesh as treatment for POP and SUI have overwhelmed the public and led to lawsuits against mesh manufacturers. With the help of the announcements made by the U.S. Food and Drug Administration (FDA), more and more women today have been made aware of the potential complications related to TVM surgery and victims of TVM complications across the United States are filing lawsuits in seeking compensations for the damage they acquired.

 

According to the FDA, there are thousands of reports involving vaginal mesh devices that were associated with defects, injuries, and even deaths. As received by the FDA, the most usual complaints were mesh erosion, infection, bleeding, pain, pelvic organ perforations, urinary defects, and recurrence of prolapse.

 

Even after FDA issued the safety awareness relating to TVM in 2008, there were still doctors who gave implants and manufacturers are still selling these medical devices to hospitals and clinics. Famous mesh producers are currently subjected to numerous lawsuits, and with the climbing numbers of complaints and the continuous application of vaginal mesh for the management of POP and SUI, more and more TVM lawsuits will pile up.

 

There are various types of vaginal mesh and different manufacturers are producing millions of them. The manufacturers involved with lawsuits in the United States recently are Boston Scientific Scimmed, Johnson & Johnson’s Ethicon, American Medical Systems, and C.R. Bard.

 

Plaintiffs continue to argue that mesh manufacturers knew that the products they are marketing were not safe to use, yet they still sold them.

 

The FDA’s Obstetrics and Gynecology Devices Panel issued a request to reclassify vaginal mesh products into high risk category, and to conduct more investigations to examine its safety and effectiveness. To some this is good news, but to those women whose lives were altered by the unhealthy effects of these products, it is not enough for the sufferings they had gone through.


References:

fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=vaginal%20mesh&utm_content=1

vaginalmeshlawsuit.com/vaginal-mesh/

businessweek.com/magazine/the-next-medical-device-controversy-vaginal-mesh-09152011.html


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