At the Vaginalmeshhelpline.com we are always looking for new information to help our readers injured by the vaginal mesh. Many women have had the mesh implanted for urinary  incontinence. We just found this online and are sharing it. The FDA has  approved  Oxytrol for women.  This is an over-the-counter Oxytrol treatment for overactive Bladder. Of course we suggest discussing this with your doctor.

January, 25, 2013 — The U.S. Food and Drug Administration today approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older.

Oxytrol will remain available for men with overactive bladder by prescription only.

Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination. Overactive bladder affects an estimated 33 million Americans, the majority of whom are older women.

Oxytrol for Women contains oxybutynin, a medicine that helps relax the bladder muscle. Oxybutynin belongs to a class of drugs known as anticholinergics. It is the first drug in this class to be made available over-the-counter for treatment of overactive bladder.

Oxytrol for Women is a patch that is applied to the skin every four days. The patch delivers 3.9 milligrams of oxybutynin per day.

“Studies demonstrate that over-the-counter Oxytrol for Women is a safe and effective treatment for overactive bladder,” said Shaw Chen, M.D., Ph.D., deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research. “Women should make sure to follow the Drug Facts label and consult their doctor if their condition does not improve.”

Oxytrol for Women’s safety and effectiveness for over-the-counter use were established in more than 5,000 subjects participating in nine studies. Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately.

Side effects reported during clinical studies were mild and included skin irritation where the patch was applied, dry mouth and constipation. A leaflet with tips to help manage overactive bladder will be provided with the product.

Oxytrol for Women is marketed by Merck, based in Whitehouse Station, N.J.

Source: FDA

Posted: January 2013

The Vaginal Mesh Helpline is keeping you up to date on all news related to vaginal mesh lawsuits, Incontinence and vaginal mesh complications and trial updates. This new FDA approval of Botox for urinary incontinence is very interesting. Many mesh victims are seeing incontinence return with the vaginal mesh failing and falling apart.  This news on Botox may be of interest to our vaginal mesh readers.

January 18, 2013 — The U.S. Food and Drug Administration today expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.

Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination.

When Botox is injected into the bladder muscle, it causes the bladder to relax, increasing the bladder’s storage capacity and reducing episodes of urinary incontinence. Injecting the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder while Botox is being injected.

“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence,” said Hylton V. Joffe, M.D., director of the Division of Reproductive and Urologic Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States.”

Botox’s safety and effectiveness for this new indication were established in two clinical trials of 1,105 patients with symptoms of overactive bladder. Patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo.

Results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. Botox-treated patients also needed to urinate on average 1.0 to 1.7 times less per day and expelled an average of about 30 milliliters more urine than those treated with placebo.

Treatment with Botox can be repeated when the benefits from the previous treatment have decreased, but there should be at least 12 weeks between treatments.

Side Effects.

Keep in mind that this could be beneficial or prove to have complications down the road.

Common side effects reported during clinical trials included urinary tract infections, painful urination, and incomplete emptying of the bladder (urinary retention). Patients who develop urinary retention may need to use a catheter until the urinary retention resolves. Patients being treated for overactive bladder with Botox should not have a urinary tract infection and should take antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure.

Botox is manufactured by Allergan Inc. based in Irvine, Calif.

The Vaginal Mesh Helpline has Launched a vaginal mesh lawsuit outreach campaign to keep women updated and informed on the progression of the transvaginal mesh lawsuits. There are still wome with complications from the mesh that do not know about the vaginal mesh lawsuits. The lawsuits are proceeding as a part of a consolidated multi district litigation. Most of the mesh lawsuits are being heard in West Virginia. The  vaginal mesh federal and   state lawsuits are growing  as 1000′s of filings  against the vaginal mesh manufacturers proceed and the number continues to grow as more and more women stand up for themselves against the manufacturers  who caused them so much pain and suffering. Federal vaginal mesh lawsuits have been consolidated into four multidistrict litigations (MDL) based on the manufacturer they’re filed against. Vaginal mesh MDL pretrial proceedings are moving in full force with Chief Judge Joseph R. Goodwin, United States District Court, WV, has set a trial date. As of October 2012, the number of suits filed against each manufacturer continues to increase rapidly:

•        AMS- American Medical Systems
•        Johnson & Johnson’s Ethicon division, Gynecare
•        Boston Scientific
•        C. R. Bard Avaulta
•        Coloplast recently added

Now would be the time to retain a vaginal mesh lawyer.

We do not want anyone to be left out. Women have suffered from these mesh implants and the Vaginal mesh lawsuits are one way to let manufacturers know you demand justice. Both you and your spouse have suffered injuries.  The  marital bond has suffered due to mesh erosion and many men have suffered injury as well during sexual intercourse. By the time all the facts come out it will be shown that 100′s of thousands have been harmed.

Manufacturer Updates

Boston Scientific transvaginal mesh lawsuits, as well as  several other transvaginal mesh litigations are currently pending in the Southern District of West Virginia,

Speak to a female medical social worker and get help guidance and support.

The Vaginal Mesh  Helpline is here ready to help you and your spouse, mother, sister, grandmother and all injured by these manufacturers who put profits over harm.

Do You Have a Vaginal Mesh Lawsuit? Do You Need a Mesh Lawyer?

The vaginal mesh proceedings have begun as a part of the two primary MDL's in West Virginia and New Jersey. Vaginal mesh lead counsels are gearing up and dates have been set.

The  vaginal mesh federal and   state lawsuits are growing  as 1000's of filings  against the vaginal mesh manufacturers proceed and the number continues to grow as more and more women stand up for themselves against the manufacturers  who caused them so much pain and suffering. Federal vaginal mesh lawsuits have been consolidated into four multidistrict litigations (MDL) based on the manufacturer they’re filed against. Vaginal mesh MDL pretrial proceedings are moving in full force with Chief Judge Joseph R. Goodwin, United States District Court, WV, has set a trial date. As of October 2012, the number of suits filed against each manufacturer continues to increase rapidly:

•     1,697 cases filed against AMS
•     1,725 cases filed against Johnson & Johnson’s Ethicon division
•     1,114 cases filed against Boston Scientific
•     1,256 cases filed against C. R. Bard

July 2012, the first case presented to a jury resulted in a $5.5 million damage award in California state court, for a woman who experienced complications where her Bard Avaulta mesh sliced through her colon, causing her to undergo at least eight additional surgeries. Additional lawsuits are scheduled for trial in federal court beginning in February 2013.

The Vaginal Helpline is in full gear to locate any woman with a Prolene mesh filed after 2002 in states where the Statute has not run out.
 

The vaginal mesh lawsuit has moved into the action stage. If you have been injured by a vaginal mesh the time to act is now. The statute of limitations for some state have run out. As the trials poceed and the facts come out it will be more important to have your lawsuit filed and with a law firm that understands the entire MDL process. Differemt criteria may start to develope and if you are not with the correct firm you may find a case rejection letter in your mailbox. Not all firms are using the same critieria. The stiffer the criteria becomes the more important the  firm you choose is. Some have much broader criteria then others. Some law firms want it clean and easy. They do not want more then one mesh implant, only one mesh with one manufacturer, no additonal surgeries or complications, no pressing merdical conditions and a variety of intricate criteria based on the way they see the case and the financial implications for the settlement. Other law firms are using a much wider criteria and still others are taking a case in a state where the statute is over to the state of the manufacturer.

Another important issue is how are your calls and concerns responded to. If your first and only contact is with a paralegal or "screener" that person is your contact person. That is the person that may be your only contact. They must understand the mesh and the suffering you have gone thru. If they can help you find a doctor I would give them an extra plus in the yes category. If they take your case strictly based on prior medical records wothout a doctor intervening on your behalf regarding your current situation it may be harder to prove your case. The best situation for you is a doctor who says it is the mesh and you need a revision of better yet, mesh removal. Having a good doctor is not only good for your case but, a medical necessity.

As the lawsuit proceeds more questions regarding your rights will develope and you will need answers. Interview the first line person.

That may be the most important person. Ask: Who will be my contact person? Has this lawyer ever done any mass tort cases? Has this lawyer been involved in the litigation of cases involving dangerous drugs and devices that harm women? What cases? To what degree?

Will my case stay with you? If it will not under what circumstances will it be referred to another firm? Remember, the MDL lawsuits will require your vaginal mesh lawsuit litigation taken to trial by one of the lead counsels. But, your lawyer can file the case and be the end of the line for the filing process. Do you need a lead counsel? Not everyone can be alead counsel. Some of the best lead counsels have inattentive, insensitive screening staff who really do not understand the mesh litigation at all. Some insensitive staff may  become very strong with you if you even raise the issue of switching lawyers.

If I do not feel my lawyer's staff is senstive to my concerns can I switch?

Yes, you can and there is no financial loss to you at all. If any law firm tells you otherwise they are just wrong and using tactics to keep you with them. That alone should be a sign to reconsider.

The most important thing is that you feel comfortable with the law firm, that they have mass tprt and MDL experience and do know the difference between an aut accident and dangerous drug and device fenseral case. They are not the same. The local lawyer you may pick for the highway accident may not be right for a mass tort. They may have no experience in mass torts and have no intention of wrking your case. They are looking for an experienced mass tort lawyer to send your case to. It may be the next guy that advertises on T,V who they do not even know.

In mass tort cases like the vaginal mesh lawsuit, local may not be the best move at all.  This is an MDL and is only being consolidated in certain states in front of a certain judge. It is not being heard in every state. It may never be litigated in your state. Local is just not all that important.

Fike you lawsuit right away and use care in selecting your vaginal mesh lawyer.

Psychological and Psychosocial Issues Surrounding the Failed Vaginal Mesh by Lisa Spitzer MSW

        Prolapse happens when the muscles of the pelvic floor weaken and cannot support the intricate system of the bladder, bowel and uterus making up the pelvic floor. When a woman ages, has a difficult child birth or a hysterectomy the pelvic floor muscles weaken. This weakening is the beginning or a dramatic change in a woman's body and how she views herself as a functioning female. This goes to the very core of her being. This is where childbirth stems from and sexual functioning. A prolapse comes in many degrees. Severe prolapse can change functioning dramatically.

       Urinary incontinence  is another result of these same life changes and weakening. Urinary incontinence can make it difficult to work and give a sense of losing control of ones functions.

      Such a sense of loss of control at this core element can dramatically effect psyhological states and the emotional well being of the female.

       Linda Mason notes in The Experience of Stress Incontinence in Women the flollowing"The results are presented within a framework that the women themselves adopted: day-to-day activities, putting the condition in some form of perspective, and feelings and emotions. For some women, stress incontinence had a great impact on their lives in terms of both their daily routine and psychologically, but others described it as a minor inconvenience that rarely disturbed their routine. Major concerns comprised the restrictions placed on the women, the worry or continual awareness stemming from the condition, and feelings of embarrassment associated with it"
AdChoices

       Along comes the vaginal mesh promising tp relieve these symptoms and support the vaginal muscles. Wome trusted their doctors who told them this was the miracle they hoped for. However, the mesh began failing and women began to be told by the doctors they trusted that the complications were all in their heads.

      The severe incontinence returned but, even worse. The prolapse came back and to make matters worse sexual intercourse was out of the question due to the severe pain. Now they had a Prolene mesh in there very core that was perceived as ruining their lives.

      The mesh created even more depression and confusion. Women were losing their husbands and in constant pain. Again, feeling the essential core of their being manipulated and violated by the male doctors they trusted. This began to feel like the invasion akin to rape. They are now more helpless then before.

       The same reactions of fear, anger and violation are experienced. Women began reaching out to other women for support and sone kind of feedback that they were not alone. It became a woman's club. Not the kind you really wanted to join but, had to out of necessity for emotional survival. Severe depression can lead to thoughts of suicide and wondering how they one will be able to continue. These intense emotional reaction and depression in a world that cannot be trusted leads to a sense of safety being shattered.

       As they learn that doctors put these products into them despite warnings they distrust the doctors they have trusted for so long and we have more fear and a sense of complete violation and vulnerability. The vaginal mesh has lead to women supporting women in a woman's club that no woman really wanted to ever belong to.

Lisa Spitzer MSW runs the Vaginal Mesh Helpline

The Vaginal Mesh Helpline is keeping you up to date on all the vaginal mesh lawsuit news. There are new developements in the vaginal mesh trials. Judge Higbee has ordered Ethicon, a subsidiary of Johnson & Johnson, to release post-marketing safety data and FDA correspondence related to its mesh products. The data is likely to include safety information the FDA requested in January 2012 from 30 transvaginal mesh device manufacturers. The FDA asked for 3 years of data on the safety and effectiveness of various mesh products.

New Data of Interest to Vaginal Mesh Victims and Their Vaginal Mesh Lawyers

Vaginal mesh lawyers are expected to review the newly released safety data on Ethicon’s products. The information may reveal key information about how the company brought its products to market, and about how much it knew about serious safety risks and complications.

Vaginal mesh may be used in the treatment of pelvic organ prolapse. This exists when a woman’s pelvic muscles become overly stretched and weakened due to multiple childbirths, surgery, or aging. The muscles may allow the bladder, uterus, or bowel to drop or fall into the vaginal wall because they are not able to adequately support pelvic organs. This may cause symptoms like pressure and urinary incontinence.

Gynecare mesh and similar mesh products were designed to provide support and help pelvic organs back into their original position. This helps to reduce urinary incontinence and other symptoms. Post-marketing reports, however, indicate that women are experiencing more pain and discomfort than prior to the surgery.

On July 13, 2011, the FDA released a safety communication noting that complications from transvaginal mesh repair for pelvic organ prolapse are not rare. The FDA also noted that even multiple corrective surgeries may not fully correct problems like erosion and infection. Other side effects may include organ perforation, bleeding, continued urinary problems, painful sexual intercourse, mesh extrusion, and recurrence of pelvic organ prolapse.

Currently, thousands of women are involved in transvaginal mesh lawsuits around the country. In addition to products made by Ethicon, other manufacturers named as defendants include American Medical Systems, C. R. Bard, Boston Scientific, and Coloplast.

Johnson & Johnson Pulls Four Gynecare Products from Market

With over 600 vaginal mesh lawsuits currently pending in state and federal courts, Johnson & Johnson and Ethicon have stopped selling four vaginal mesh implants. In correspondence filed June 4, 2012, the companies told Judge Joseph R. Goodwin, who is overseeing the current vaginal mesh MDL in the U.S. District Court in West Virginia, that they would cease commercializing the four products and plan to phase them out completely by early 2013.

Products included in the phase-out include:

    Gynecare TVT Secur
    Gynecare Prosima Pelvic Floor Repair System
    Gynecare Prolift Pelvic Floor Repair System
    Gynecare Prolift MTM Pelvic Floor Repair System

Despite this move, the companies will still be expected to release safety data regarding these four products for the New Jersey litigation.

The Gynecare Prolift device was the subject of an earlier controversy, when documents released from a New Jersey lawsuit revealed that Johnson & Johnson continued to sell the mesh even after the FDA directed the company to halt sales because the device lacked the appropriate clearance.

We will continue to keep you updated as new developements occurr.

The dates have been set to begin two manufacturers vaginal mesh trials. Vaginal mesh lawyers will begin the steps to bring justice to 1000's of women whose lives and bodies have turned to turmoil by a Prolene plastic mesh. The mesh was originally tauted as the cure all for urinary  incontinence, bladder, bowel and uterine prolapse. But, there were problems and the adverse incident reports and warnings began to surfice. In 2008 a warning was issued by the FDA.  As these mesh lawsuit trials begin we will hopefully begin to bring justice to the tens of thousands of women injured by the mesh.This is just the beginning and there is still time to file your mesh lawsuit.

Vaginal Mesh Lawsuit Trials Are Ready to Begin

Ethicon Gynecare Trials to Begin Next Year

The first Ethicon Gynecare pelvic mesh lawsuits are scheduled to go before a jury near the end of next year in New Jersey state court. Thes will be presented by lead vaginal mesh lawyers.

Judge Carol E. Higbee, who is overseeing the consolidated Ethicon vaginal mesh lawsuits in New Jersey Superior Court, has scheduled the first Ethicon Gynecare test cases, known as bellwether trials, to begin in November 2012.

Preliminary discovery for cases being prepared for early trial dates is to be completed by March 30, and expert witnesses are to be deposed by October 5, according to a scheduling order Judge Higbee issued on October 28.

More than 350 lawsuits over Ethicon Gynecare transvaginal mesh have been centralized under Higbee for pretrial proceedings.

The cases involves women who received Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling or another pelvic mesh product manufactured by Ethicon.

Bard Trials To Begin Next Year

C.R. Bard Inc. will face its first federal-court trial next year over claims that the company’s vaginal-mesh implants injured women.

U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, set a Feb. 5 trial date for the first of about 600 federal cases contending that Bard’s Avaulta device caused organ damage. Goodwin is overseeing a consolidation of cases filed in federal courts across the U.S. against Bard, Johnson & Johnson and other makers of vaginal-mesh inserts.

The order of trials for the first federal cases over Avaulta “will be determined after completion” of pretrial information exchanges between Bard and the plaintiffs, Goodwin said in his order yesterday.

We will continue to report as the news comes out.

The Vaginal Mesh Helpline lawsuits lawyers  and the Mesh Helpline are keeping women updated on all new vaginal Mesh lawsuit news. Coloplast has been added to the Multi district mesh lawsuits. Their brands are listed below.

 Coloplast Products Have Been  Named in The Vaginal Mesh Lawsuits
According to their website, Coloplast develops products and services “to make life easier for people with deeply personal and private medical conditions.” The company has a special focus on surgical urology, developing surgical devices for both men and women. For women, Coloplast markets products to treat pelvic organ prolapse and to control urinary incontinence.
The August 6 order by the JPML centralized 13 Coloplast pelvic mesh lawsuits into West Virginia. All plaintiffs allege that the company’s products caused serious injuries. The products at issue in these lawsuits, Novasilk, Exair, Suspend, and Axis, are used to treat pelvic organ prolapse by supporting weakened pelvic muscles.
Consolidation into one court helps conserve resources, increase efficiency, and reduce the risk of duplicative discovery or conflicting rulings from other courts. Each lawsuit retains its individual nature, however, and will be returned to its original court for trial after pre-trial proceedings are complete.

Wome are advised to file litigation immediately to avoid being closed out due to a staute of limitation issue in your state. All the noted mesh ccomplications are being seen in these mesh devices.

Coloplast Lawsuits

• Novasilk
• Exair
• Suspend
• Axis

The vaginal mesh lawsuits are heating up. Thousands of new cases are being filed in a total of 6 MDL's (Multi-District Litigations ).

Wome are being to figure our it is the mesh despite what their doctors are telling them. They are shouting  for justice for a Prolene mesh product that has wrecked havoc on their bodies and marriages. The majority of women implanted with either a vaginal mesh or bladder sling cannot have sexual intercourse.

Women are in pain and the complications and horrific stories of a failed mesh we hear on a  daily  basis are increasing. Women are seeing the vaginal mesh lawyer lawsuit ads on T.V and it is all starting to make sense and come together. They call for help in locating a doctor and lawyer that they can trust.

In response to this the Vaginal Mesh Helpline now has a network of pre-screened lawyers and is working to compile a list of trusted doctors.

Contact us today for a vaginal mesh lawsuit lawyer and doctor.