The Vaginal Mesh Helpline continues to report on the news that effects women with vaginal mesh complications. The new FDA tracking system comes a little late for the over 300,000 women implanted with vaginal mesh devices and suffering. However, there is hope. This sends a message that our voices have been heard. By filing vaginal mesh lawsuits and standing up for justice you protect yourself and all women from becoming targets of manufacturers who put profits over people.

FDA’s Propose Tracking System Could Reduce Vaginal Mesh Complications
Tracy Ray

The FDA has proposed a new regulation that would require all new medical devices to carry a unique device identifier (UDI). The UDI would be a code of letters and numbers. Such a code would make it much easier to track devices, which in turn would make it much easier to report complications with a particular model or to find out about such problems.

According to the FDA, “A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.”

For example, if such a tracking system were in place, a doctor who had a patient with stress urinary incontinence (SUI) or pelvic organ prolapse (POP) and wanted to implant a vaginal mesh device could look up the different models by the UDI and immediately see what transvaginal mesh complications, if any, had been reported with each specific model. Likewise, in the event of a recall, a UDI would make the process much more efficient: the company or the FDA would simply announce that the model carrying a particular UDI number was being recalled.

The FDA’s proposal was a response to legislation passed by Congress in 2007 that directed the FDA to develop regulations establishing a unique device identification system for medical devices.
Many women have suffered transvaginal mesh complications

Such a system might enable future patients to avoid problems resulting from transvaginal mesh. Many women have suffered such complications, including pain, infections, mesh erosion, protrusion, vaginal scarring, dyspareunia, and perforation of the bowels, bladder, or blood vessels. Many of these devices were approved under the FDA’s controversial 510(k) approval process, which allows products to be approved without first undergoing clinical trials to prove they are safe.

If the physicians treating these women had been able to easily look up the type of vaginal mesh device they were considering implanting, and immediately see reports of problems associated with the device, they would have been able to weight the risks and make an informed decision about whether to implant that particular device.
Vaginal mesh MDL consolidated lawsuits

Many women who have suffered complications have filed vaginal mesh lawsuits in order to get compensation for their pain, suffering, and reduced quality of life. Most of these lawsuits charge that the manufacturers of these devices did not test them for safety before putting the on the market and failed to warn the public of the devices’ risks. A number of federal lawsuits have been consolidated in a vaginal mesh MDL in West Virginia.

For help call the Vaginal Mesh Helpline and Vaginal Mesh Support Group today, Let us help you find and vaginal mesh lawyer and doctor.

The  Mesh Helpline still hears from women who are having complications and just realized it is from the mesh. Most of these women have seen a lawyer ad on T.V which alerts them to realize they are not alone and that their doctors are giving them the run around. Other women are disenchanted with the T.V ad lawyer they hired or a local lawyer who has sent the case to another lawyer someplace else. There are some basic vaginal mesh guidelines:

Vaginal mesh complications include pain, leakage or incontinence or the bladder or bowel, parch bleeding, infection, pain during sexual intercourse, lower back pain, pain on one side of the body, abdominal pain and difficulty standing for long periods

You are not alone. Close to 400,000 women have vaginal mesh or bladder sling implants

A vaginal mesh comes in many varieties, made by many different manufufacturers. They can be called a sling, a transvaginal mesh, a TVT sling, a bladder sling, a surgical mesh, a vaginal patch and it is still a mesh and part of the Vaginal mesh lawsuts currently underway.

For the men: Sexual intercourse is indeed painful for your wife. She is not lying or making it up. But, with the right doctor there is hope of resuming a normal life. Many men are sueing with their spouse. A California husband just got an award  for $500,000 for loss of intimacy in the relationship.

The mesh can be removed and your body repaired with sutures or another means. A urogynecologist is usually a mesh specialist although a GYN surgeon or urologist can remove the mesh. You must ask the doctors office if the doctor has ever removed a mesh and you must get a straight answer.

Physical therapy will not help the mesh and may be dangerous by pushing it into an organ. This is not a good idea. Estrogen creme will not necessarily help either. You must look into mesh removal.

The vaginal mesh lawsuits are currently underway. It is important to retain a lawyer, and the right lawyer, asap. Statutes of limitations are running out in some states. You will have to go to a doctor to get a statement that you have a mesh problem. If you rely on old medical records it may become harder to prove your case. The best situation is to have a statement in the record that mesh removal or alteration is needed and that you have a mesh issue.

Additional Important Information

Surgical mesh was designed in the 1950s to correct abdominal hernias. The woven material is placed below the skin to patch the abdominal hole and block intestines and other tissues from protruding through the abdominal wall.

Surgical mesh can be made of biological materials or synthetic materials like polypropylene, polytetrafluoroethylene, polyester fibers or stainless steel. The size, shape, thickness and flexibility vary based on the surgeon’s needs. Often, the mesh comes in a prepackaged kit with the necessary tools, to make the procedure easier.

The Food and Drug Administration (FDA) reports that hundreds of thousands of hernia repair surgeries are performed each year — with and without surgical mesh — and patients typically recover quickly. However, the FDA has received reports of adverse reactions to the mesh, adhesions (where the loops of the intestines attach to each other or the mesh), and injury to organs, nerves or blood vessels.

Overall, the treatment of hernias with surgical mesh is considered successful, so doctors wanted to use it in other parts of the body that required additional support. In the 1970s, they began inserting surgical mesh abdominally to treat pelvic organ prolapse (POP). In 1996, the FDA approved the first mesh product for treatment of stress urinary incontinence (SUI). The first mesh product for treatment of prolapse was approved in 2002.

Instead of inserting the mesh through abdominal incisions, however, surgeons have recently embraced the idea of implanting the mesh transvaginally (through the vagina). This choice has been disastrous for thousands of women, who have suffered severe complications such as organ perforation and erosion of the mesh. Even revision surgeries cannot always remove the mesh or correct the internal trauma.
Transvaginal Mesh and Pelvic Organ Prolapse

To treat pelvic organ prolapse, surgical mesh can be implanted at the time of a hysterectomy or as a separate surgery. When surgical mesh is inserted through the vagina, it is referred to as transvaginal mesh.

Pelvic organ prolapse is a condition in which the bladder, top of the vagina, uterus, rectum or bowel has descended from its normal position. The condition is thought to be the result of weakened pelvic muscles, usually from pregnancy and childbirth. Of the 300,000 surgical procedures done to correct prolapse in 2010, 100,000 used mesh and 75,000 of those were completed transvaginally.

When transvaginal mesh is used to repair prolapse, the surgeon uses the woven material to create a hammock-like structure under the drooping organ or organs. Once in place, the mesh is anchored to muscles or ligaments by sutures or other devices. Over time, the patient’s tissues grow and fill in the pores of the mesh to keep it stable. The hammock, in turn, maintains the correct position of the affected organ.
To treat prolapse, transvaginal mesh is most commonly placed in these locations:

    The anterior vaginal wall to correct a bladder prolapse.
    The posterior vaginal wall to correct a rectal prolapse.
    The top of the vagina to correct a uterine prolapse.

The most common and serious of the complications for patients is the erosion, or extrusion, of the mesh into nearby organs. This can lead to bleeding, pain during sexual intercourse and urinary problems. Revision surgeries may not fix the problem. And if the patient’s tissues have already grown through the mesh, removal may be impossible.
Transvaginal Mesh and Stress Urinary Incontinence

Surgical mesh can also be used to create a bladder sling that is positioned under the urethra and bladder neck and anchored on the sides. The bladder sling is designed to treat stress urinary incontinence (SUI), which occurs when the bladder is stressed by an everyday activity, such as sneezing or laughing, and subsequently leaks urine. The sling keeps the urethra and bladder neck closed during normal activities, stopping the leakage. In 2010, nearly 260,000 surgeries were performed to correct SUI. Of those, 80 percent were performed using surgical mesh implanted transvaginally.

When a bladder sling is inserted through the vagina, it is known as transvaginal mesh. Typically, small abdominal incisions are also used.
Among the most popular bladder slings:

    Tension-free vaginal tape (TVT): A polypropylene mesh tape is used under the urethra and is held in place by the patient’s body.
    Transobturator tape (TOT): Less invasive than TVT, because there is no need to use a large needle when inserting it.
    Mini-sling: Eliminates the need for abdominal incisions. A metallic inserter and a vaginal incision are used to place the mesh tape.

As with prolapse surgery, there have been widespread reports of serious complications after bladder sling surgery using transvaginal mesh. Many patients have prolonged difficulty urinating or they incur new symptoms of incontinence, specifically urgency. In addition, they run the risk of the slings eroding into nearby structures, organ perforation, infection at the surgery site and internal bleeding.
Transvaginal Mesh and the FDA

Between 2005 and 2007, the FDA received 1,000 reports of complications and injuries related to transvaginal mesh surgeries, including death. The FDA decided to begin studying the medical device in October 2008. The FDA reported that between 2008 and 2010, there were nearly 2,900 reports of injuries caused by transvaginal mesh.

By July 2011, the federal agency concluded in a public safety update that complications with the use of transvaginal mesh for treatment of prolapse are not rare and that mesh repairs are no more effective than non-mesh repairs for treating prolapse.

The FDA took its concern a step further in January 2012, stating that after studying years of scientific data and recommendations from the September 2011 Obstetrics-Gynecology Devices Panel meeting, it was considering reclassifying transvaginal mesh as a high-risk device. If that happens, mesh devices will be subjected to more rigorous testing, including clinical trials with humans.

In that same update, the FDA requested safety data from all surgical mesh manufacturers and ordered post-market studies from seven manufacturers of single-incision mini-slings for SUI and 33 manufacturers of surgical mesh for prolapse.

If you need help with your vaginal mesh call the Vaginal Mesh Helpline today.

The Vaginal Mesh Helpline is seeking all women with a vaginal mesh to help you  file your vaginal mesh lawsuit. Ladies, please do not wait. Time is running out. This couple won and won big. Justice spoke and responded to their suffering. Many women we speak to are waiting. Do not wait. Some of the state statutes are running close. See the settlement for this couple below.

Couple wins landmark trial against  Vaginal Mesh medical company. File Your vaginal Mesh lawsuit today. Call the vaginal mesh helpline and get a vaginal mesh lawyer that will work with your best interests at heart. This couple won big and they did not get their case referred around the country from lawyer to lawyer. You must get a vaginal mesh lawyer who is keeping your case or works with a known lead lawyer. KNow where your case is. Get the vaginal mesh settlement you deserve.

Legal and medical professionals from across the country are paying very close attention to a groundbreaking verdict that happened in Bakersfield. For the first time in the nation, a jury has awarded a local couple $5.5 million against the maker of a medical implant, claiming they knew their product was unsafe. Christine Scott got the official news Monday morning at Kern County Superior Courthouse. She had a vaginal mesh surgically implanted and has had complications ever since. She and her husband sued the maker and won, making it the first victory of its kind in the nation. "I was like 'Thank you, God.' We can finally get the word out to women," said Scott after the verdict. After some four years of legal battles and court-ordered silence with the maker of the Avaulta Mesh, C.R. Bard Medical, Scott gets some relief from the victory. An active runner, Scott got the implant to correct a leaky bladder. But, the device began cutting her colon, and tissue continues to grow through the tiny holes in the mesh. She had already had eight surgeries when we first met Scott last month. "I don't know if I'll have ten surgeries now. I don't know if I'll have one. I don't know if I'll have 100. The doctors cannot tell me," Scott said in June. A jury awarded Scott $5 million and her husband $500,000, claiming the mesh has ruined their love life. It's a landmark victory, the first of its kind in the country. The Securities and Exchange Commission indicates 47,000 women have had the mesh implanted, and 650 lawsuits are pending. "In fact, this case, they advertised it as FDA-approved. It's not. It's a crime," said Gene Lorenz, a lawyer representing Scott. The lawyer for C.R. Bard Medical says the company stopped selling the Avaulta Mesh on July 1, 2012 in the United States because the FDA wanted more clinical trials done. But, it's still sold in other countries. "This is a product that has been cleared for use by the FDA and can be safe and effective when used properly and for the right patient," said Michael Brown, attorney for C.R. Bard Medical. "They tested this on 16 rats, 12 rabbits, four sheep and, by their own researcher's admission, the next living being this product went into was women," said Elaine Houghton, Scott's attorney. Scott says she will continue to deal with complications from the mesh, while being a voice for other women. "The hardest part, I will tell you, through this whole thing, is having to keep quiet, watching women still get hurt. But, I was legally not able to get out there and tell and that, I'm sorry," said Scott holding back tears. "And, that every day I was like please be over so I can talk. So, when I got that verdict it was like 'Thank you God.' Now we can do something." There will likely be an appeal in the case, but Scott says she's just happy to no longer have the court-ordered silence, so she can talk about it. She wants to start a support group for women. And, her lawyers are working on a website for people wanting to know more about mesh implants. They hope to have that up and running by Monday.

Call us today and let us help you find a vaginal mesh lawyer and doctor. With so many lawyers advertising and so few doctors willing to help it is very difficult to know what to do. Call and speak to our female medical social worker today.

Vaginal Mesh Helpline  is provideng vaginal mesh support and Avaulta mesh lawyers for women with complications from the Bard Avaulta Vaginall Mesh. Like all mesh implants  the Bard Avaulta Vaginal Mesh was used for prolapse or unrinary incontinence and is causing all the classic mesh complications.

C.R. Bard's products include:

        Bard Pelvitex
        Bard Pelvisoft
        Bard Pelvilace or Pelvicol
        Bard Utrtex
        Bard Uretex TO
        Bard Uretex TOO2
        Bard Uretex TOO3
 

Complications with Bard Avaulta Vaginal Mesh Include:

•     Severe physical pain
•     erosion of the mesh
•     pain during sexual intercourse
•     Difficulty voiding
•     patch bleeding
•     lower back pain
•     Reoccurrence of POP or SUI
•     Severe infection
•     Urinary  related problems

Bard Avaulta Mesh Lawyers are filing lawsuits for women with complications from the Bard Avaulta Vaginal mesh.
 
If you have complications from a Bard Avaulta vaginal mesh do not wait because the first Bellwether trial is  scheduled in the Bard Avaulta Mesh Implant MDL

The trial is now set to begin on February 5, 2013 in the U.S. District Court for the Southern District of West Virginia.

The purpose of bellwether trials is for both parties to get an idea of how juries will respond to common evidence in representative trials. They can then use this information to negotiate settlements, to plan their strategy for future trials, or to serve as precedents. In January, Judge Goodwin told the attorneys in the Bard MDL to compile a list of possible bellwether cases. Now that a date has been set for the first bellwether trial, a schedule will be established for the discovery process so that the pre-trial proceedings can begin.

You must retain an experienced multi district litigation lawyer immediately. Call the Bard Avaulta vaginal mesh helpline today.

Use of Vaginal Sling During Surgery Linked to Increased Urethral Sling Complications 1 877 522-2123

Vaginal Mesh Helpline Medical  Update reports on a June 21, 2012 study published in The New England Journal of Medicine, which found that though the insertion of a vaginal sling during surgery decreases the chances of postoperative urinary incontinence, it carries higher risks of urethral sling complications.*

The study analyzed data from 337 participants who underwent surgery to treat pelvic organ prolapse (“POP”) between May 2007 and October 2009. The women were randomly assigned either a vaginal sling or sham incisions. The study found:

        After three months, 23.6 percent of women with the sling had urinary incontinence, compared to 49.4 percent without a vaginal sling.

        After 12 months, 27.3 percent of patients with the sling suffered from urinary incontinence, compared to 43 percent of those without.

        Those implanted with the sling suffered complications. Nearly seven percent of the sling group suffered bladder perforation, versus none in the control group.

        31 percent of women experienced urinary tract infections as a urethral sling complication, versus 18.3 percent in the non-sling group.

        Bleeding complications occurred in 3.1 percent of the sling group; incomplete bladder emptying occurred in 3.7 percent of the sling group. Neither occurred at all in the non-sling group.

Urethral Sling Complications Adds To Concerns About Vaginal Mesh Side Effects

According to an accompany commentary to the study, vaginal mesh slings are different from other types of transvaginal mesh used for POP repair. The slings are small and shaped like straps, approximately 1 cm wide and 10 cm long, while vaginal mesh sheets can span up to 10 cm wide and 20 cm long. In September 2011, the U.S. Food and Drug Administration (“FDA”) convened a panel to evaluate the safety of vaginal mesh implants. Although the agency recommended post market studies for transvaginal mesh, they did not require such studies for midurethral slings. The latest study raises questions about the risks and benefits of vaginal mesh slings. The FDA noted that the vaginal sling provides an “anatomic” benefit, but may not result in better symptomatic results. Since the study was limited to a one year follow up, the long-term consequences of urethral sling complications are still unknown.

Current vaginal mesh lawsuits are increasing. There are numerous vaginal mesh related implants creating severe complications. Many women do not realize that all of these are mesh devices and are part of the huge vaginal mesh lawsuits. The Vaginal mesh helpline currently has a number of pre screened experienced Tort lawyers  for women seeking to file vaginal mesh lawsuits. We cxan also help with doctors in some states.

You have been probably reading alot lately about the mesh and the fact that it is a Multi District litigation. In fact that is what this lawsuit is. The vaginal mesh is not a class action lawsuit. Your case is filed locally and then moved to the appropriate MDl  that the manufacturer of your vaginal mesh has been assigned to.

What is a MUlti District litigation ?

Multidistrict litigation is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. The decision whether cases should be transferred is made by a panel of seven federal judges appointed by the Chief Justice of the United States Supreme Court. The Judicial Panel on Multidistrict Litigation meets periodically to review requests that cases be consolidated for pretrial matters pursuant to 28 U.S.C. § 1407

Vaginal mesh MDL'S

In December 2008, all Mentor ObTape lawsuits pending in federal courts were consolidated for MDL in the United States District Court for the Middle District of Georgia, before the Honorable Judge Clay D. Land. In October 2010, 36 lawsuits against Bard (manufacturer of one brand of vaginal mesh) were consolidated for MDL in the Southern District of West Virginia; the number of included cases has since grown to nearly 300. The first vaginal mesh bellwether trial against Bard is scheduled to begin on February 15, 2013. Later, in February 2012, the Judicial Panel on Multidistrict Litigation created three additional MDLs in the Southern District of West Virginia; the defendants are: American Medical Systems; Boston Scientific; and Ethicon. Also in October 2010, Judge Carol E. Higbee of the Superior Court of New Jersey ruled in favor of centralized management for all current and future complaints against manufacturers Johnson &Johnson and Bard (more than 400 such cases have currently been filed). The New Jersey cases are not part of a federal MDL, but are being managed on a state level.

A motion has been filed to create a sixth transvaginal mesh MDL, involving lawsuits over Coloplast pelvic mesh, and a panel of federal judges will meet later this month to consider whether the cases should be consolidated for pretrial proceedings and centralized before the same judge in West Virginia who is presiding over cases involving similar products sold by other manufacturers.

To Summarize the vaginal mesh MDL

There are currently four different MDLs (multidistrict litigations) centralized before Chief District Judge Joseph R. Goodwin in the U.S. District Court for the Southern District of West Virginia, involving lawsuits over transvaginal mesh products sold by C.R. Bard, American Medical Systems (AMS), Boston Scientific and Ethicon.

A fifth MDL, which was established in 2004 for lawsuits involving Mentor ObTape, is centralized in the U.S. District Court for the Middle District of Georgia. However, many of the Mentor ObTape lawsuits have already settled and the litigation is at a very advanced stage.

Update on Vaginal Mesh Proceedings

Judge Issues Order to Proceed with Discovery in Vaginal Mesh MDL
Emma Gonzalez | July 6th, 2012 |

On June 14, 2012, Chief District Judge Joseph R. Goodwin, who presides over the U.S. District Court for the Western District of West Virginia, issued a pretrial order to proceed with discovery processes in the transvaginal mesh lawsuit MDL. In laymen’s terms, this means that lawyers for the plaintiffs, who allege a variety of vaginal mesh problems, are now able to request evidence, documentation and other paperwork from product manufactures and defendant companies.
Discovery to seek evidence of vaginal mesh problems

True to name, discovery is a legal term for the pretrial process of “discovering” evidence from the opposing party. In this case, Judge Goodwin has authorized vaginal mesh attorneys to seek depositions, interrogatories (fact-gathering questionnaires), and other supporting documentation from vaginal mesh manufacturers and other named defendants. Judge Goodwin’s order is a very important step for the MDL, as it allows counsel to prepare for the first trials.
Judge presides over four transvaginal mesh lawsuit MDL’s

Judge Goodwin will preside over several transvaginal mesh lawsuit MDL’s – those against American Medical Systems, Boston Scientific, C.R. Bard, and Ethicon. While Judge Goodwin has been assigned to the C.R. Bard MDL since 2010, it was not until 2012 that the other three were consolidated and appended to his court docket. The four MDL’s consolidate cases from thousands of women, and currently number 333 against AMS, 182 against Boston Scientific, 411 against C.R. Bard, and 253 against Ethicon. MDL numbers are growing fast, and this rapid rate is not expected to decrease in the near future.
Vaginal mesh attorneys cite range of complications

MDL plaintiffs allege several vaginal mesh problems, among them pelvic organ prolapse and stress urinary incontinence aggravated by vaginal mesh. Additionally, women report chronic infection, bleeding, vaginal scarring, severe discomfort, and pain during intercourse. For some, what was meant to be a solution to their problems results in device erosion – deterioration of the implant – or extrusion, in other words, dislocation of the implant to such a point that it protrudes into the vaginal canal. In the worst of cases, women allege that their defective implants cannot be completely removed, even after multiple surgeries.

It is important to understand that a local lawyer is not necessary for the Vaginal mesh lawsuits. That lawyer will not necessarily be a part of the proceedings but, will most likely be seniding your case to another law firm that is equipped to handle mass torts.

Lead Counsels and the vaginal mesh MDL

On April 13th, Chief Judge Joseph R. Goodwin held a hearing to consider what MDL attorneys will be appointed to serve as lead counsel for the plaintiffs in the consolidated transvaginal mesh litigation.  Attiorneys from around the country comprise the Executive Committee and fifty firms comprise the PSC.

That is why it is extremely important for you to hire an end of the line lawyer so that your casr is not moved from a local law firm to a larger law firm to the MDL lead counsel. Many lead counsels are just end of the libne lawyers and are not taking cases, others are. Your attorney must be familiar with the MDL process. for the Vaginal mesh Helpline dial 1 877 522-2123

Are you suffering from a vaginal mesh implant? Beware of email blasts and email solicitations. Be aware that  these  may or may not be coming from lawyers. Leads companies collect these and sell them to lawyers for $400-$800 a lady with a mesh. Yes my dear mesh victims they are after you and they really do not care about how you are suffering. They are being sent to everyone. These people do not know you have a mesh. Men are even getting them. These may just be  money machines after you and trying to cash in on your misery. You may have gotten this:                                                                                                                                                                            VAGINA MESH F-D-A ALERT!

Mesh Patch Lawsuit Center

Have you or a loved one suffered from complications from a Mesh Implant?

Click Here for your Free Private Case Evaluation:

Serious complications associated with surgical mesh implants.

Click Here for your Free Private Case Evaluation:

You or your loved ones may be entitled to compensation for your injuries.
There is limited time to file your claim, do not delay!

Click Here for your Free Private Case Evaluation:

OR MAYBE YOU GOT THIS ONE ?

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Serious complications associated with Surgical or Pelvic Mesh Implants.

In July 2011, FDA warns increased risk of serious and painful complications associated with the transvaginal surgical mesh.
Contact us now for more information about your rights!
Surgical or Pelvic Mesh Implant lawsuits are being reviewed for women who have experienced:

    Infection
    Vaginal Pain
    Urinary problems
    Pelvic Pain

    Erosion of the mesh into the vagina
    Hardening of the vaginal mesh
    Injury to nearby organs
    Difficulty during sex

Brand names of Mesh Implants that many patients have reported problems with consist of:

    Boston Scientific®
    Caldera®
    Sofradium®
    Tyco®
    Ethicon®

    Gynecare Prolift ®
    C.R. Bard Avaulta®
    Johnson & Johnson®
    American Medical Systems®
    Mentor Corporation®

Other possible Surgical or Pelvic Mesh Implant side effects include:

    Pain
    Erosion through vaginal epithelium
    Recurrence of prolapse and/or incontinence
    Bowel, bladder, and blood vessel perforation
    Dyspareunia

If you or a loved one has suffered an injury or complication from a Surgical or Pelvic Mesh Implant you may be entitled to substantial financial compensation!
There is limited time to file your claim!
DON'T DELAY!
Find out if you are entitled to compensation for your suffering TODAY!

THIS IS AN ADVERTISEMENT

This website is not affiliated in any way with CR Bard Inc. Bard Avaulta ® is a registered trademark of CR Bard Inc. Gynecare Prolift +M® is a registered trademark of Johnson & Johnson.

Consult your doctor or physician before starting or stopping any medications.

This website is a free matching service only and is not responsible for services or information from third party providers. This site does not provide tax or legal advice, and services are not available in all states.
 

These may be  leads companies, not a lawyers. If you are suffering from a vaginal mesh and want some good solid concerned medical advice and legal help call the Vaginal Mesh Helpline and speak to a female medical social worker, MSW, LCSW, with almost 3 decades experience working with people in need and over two decades working with the legal community.  All our lawyers are end of the line attorneys.All lawyers we deal with go thru an extensive screening process. All the lawyers in our network work with each other to your best interest. They are end of the line lawyers. Each office has a female repesentative or lawyer  experienced with the mesh. Beware all the emails and direct solicitations. These are not allowed in many states.

We care about you and our goal is to get you to a doctor that can help you and get you justice for your misery. You are not alone. Be aware that the staute of limitations is running very close in many states. You should have legal representation but, chose wisely. For help call us at 1 877 522-2123

Vaginal mesh helpline is ready to share any new events that are in favor of Protecting our " Women of the Vaginal mesh". Lawyers Nationwide protecting women and our vaginal Mesh lawyers are filiing lawsuits and congress finally is moving on the vaginal mesh disaster. See  this:

Vaginal Mesh & FDA 510(k): Copycat Killers and the Dangers Within the System
The FDA has allowed the manufacturers of polypropelene transvaginal mesh and other devices to enter the US marketplace with very few safety checks. Congress is taking some important steps toward changing this system, but, it is important to remember that the manufacturers of these devices are in the best position to warn the public of known dangers and they should be held accountable when their silence leads to people being injured.
The 510(k) Process
Medical Devices come into the market place through one of two premarket processes. One method is to undergo the Premarket Approval process, including clinical trials in humans and demonstrations of safety and efficacy. This process typically only applies to “risky” devices and is not used very often.
The more common path a device will take is through the Premarket Notification process, more informally known as 510(k) clearance. Most devices are cleared through 510(k) because the FDA is required to review devices through the least burdensome means.
The FDA does not require 510(k) devices to undergo clinical testing to demonstrate safety or effectiveness prior to clearing the devices for sale. Instead the device manufacturer must only show that the device is “substantially equivalent” in safety and efficacy to another previously approved device or standard recognized by the FDA, also known as a “predicate device”.
In order to be eligible for clearance, the new device must exhibit roughly the same safety and effectiveness characteristics as the predicate device. That means the device must have the same intended use and technological characteristics as the cited predicate, and that the device poses no new safety or efficacy concerns.
Critics of the 510(k) clearance process point out that it doesn’t require devices to be shown effective in human populations and such devices can pose great danger to the unsuspecting American public as a result.
What is striking about the “substantially equivalent” standard is that a device can be found “substantially equivalent” to a device that is no longer on the market as well as a device that has been recalled from the market for its adverse effects in patients. So long as the FDA has not issued a mandatory recall of the device, it remains eligible to qualify as a “substantially equivalent” predicate device. It should be noted that mandatory recalls occur very rarely – a manufacturer must fail to voluntarily remove a dangerous product from the market.
It is not uncommon for a recalled and dangerous device to serve as the predicate devices for hundreds of other new devices. The FDA is required by law to clear all devices found to be “substantially equivalent” to their predicates, regardless of safety and efficacy concerns.
Transvaginal Mesh – The CopyCat Killer
The scope and severity of injuries caused by transvaginal mesh implants have made this device a prominent example of the dangers of 510(k) premarket clearance.
In his report, Defective Devices, Destroyed Lives, Congressman Edward Markey points to the “predicate lineage” of many vaginal mesh products currently on the market as the cause for their dangerous characteristics. A number of mesh products produced by both Boston Scientific and Ethicon (a subsidiary of Johnson and Johnson) are currently marketing mesh products found to be “substantially equivalent” to Boston Scientific’s ProteGen.
ProteGen was recalled in 1999 after hundreds of women reported experiencing severe pain, infections, and complications. Many of the women suffering today as a result of vaginal mesh could have been saved the pain and discomfort they are experiencing if the FDA clearance procedure was more stringent regarding substantial equivalency or if the manufacturers had warned of the dangers.
Congressman Mackey and his fellow supporters seek to make the FDA device clearance process more stringent, and thereby make the devices on the market safer for the public. At the end of this month Congress will vote on the Safety of Untested and New Devices (SOUND) Act, H. R. 3847. SOUND seeks to improve the safety and efficacy of medical devices by giving the FDA the ability to reject a device based on a predicate that has been recalled. It further requires companies to inform the FDA if products in a device’s lineage have caused harm and instructs the FDA to create a database of dangerous devices so that manufacturers can determine what an acceptable predicate device is. And lastly the bill calls for the FDA to review high-risk devices if a product in their lineages has been recalled. So far, the bill has yet to gain any Republican support and seems unlikely to pass.
Whether the SOUND Act passes or not, it is imperative that the FDA revamp is clearance processes for medical devices as people are loosing their lives everyday. There have been more than 7 confirmed deaths related to vaginal mesh alone. Congressman Mackey points out that the “FDA must have the flexibility to reject devices like mesh that are based on recalled products. These deadly devices are copycat killers.”
We completely agree with the SOUND Act and commend the work of Congressman Mackey. However, we believe that the safety of the American public requires that the manufacturers also be held accountable for placing dangerous devices on the market.
It is important to remember that the manufacturers of the mesh kits are in the best position to warn the public of complications on a timely basis. The FDA estimates that 300,000 women undergo surgeries using vaginal mesh on an annual basis – timely warnings are necessary so that women facing surgery are given all information necessary to make important decisions about their health and safety.

Vaginal mesh helpline 1 877 522-2123

At the vaginal mesh helpline we continue to be amazed at the numbers of Dangerous drugs and medical devices harming women. Our dangerous Drugs and medical devices harming women is reaching out to Victims of yaz and Yasmin with a newly launched campaign. Although our main focus is to help the thousands of women iinjured by the vaginal mesh we feel that all dangerous drugs and devices that harm women should be looked into. The FDA mist be made aware. Wome have become the biggest target for these drug and device manufacturers The latest yaz Yasmin Birth control Pills have just started the settlement process. Bayer has stated offering settlement monies. Yaz has warnings for Blood clots and new extreme warnings have been added to the label. This is a bit late for young women with blood clots, Pulmonary embolism, Strokes, heat heart attacks and deep vein thromboisis form yaz or yasmin. Mothers have lost daughters and Husbands have lost wives, children have lost mothers.  Young college girls have ended up in emergency rooms rather then classrooms with strokes and heart attacks.

Lets Take a Look at yaz and Yasmin

Yaz Birth Control Pills Helpline, Yaz lawyers

Call the Vaginal mesh helpline and speak to a female medical social worker about Yaz . Yaz cases are being reviewed for Yaz related strokes, blood clots, pulmonary embolism, and deep vein thrombosis.The FDA has demanded new warnings on yaz labeling  for strokes and blood clots and it is well known that Yaz can cause strokes , heart attack and pulmonary embolism. Many young  college women have had  blood clots while on Yaz birth control pills.  We are  concerned about the life changing effects this can have on young women.

Yaz has been shown to cause Strokes, Pulmonary Embolism and Heart Attacks

A stroke occurs when blood supply to part of the brain is disrupted, causing brain cells to die. Blood flow can be compromised by blood clots. The FDA has demanded  new  stronger  Yaz  warnings for blood clots.

Yaz related Blood Clots

Blood clotting is important but, some blood clots can travel and be life threatening. If a blood clot dislodges and travels to the brain, it can cause a stroke. Blood clots in the  leg veins are called deep venous thrombosis. These blood clots can dislodge and move. to the lungs.

Yaz Pulmonary Embolism Risk Is Based on the Blood Clot Risk

The estrogen in combined-hormone contraceptives such as Yaz and in other hormonal treatments increases the risk of blood clot formation. Blood clots are the most frequent cause of pulmonary embolisms; a pulmonary embolism occurs when a blood clot in the body breaks free from the site where it formed and travels to a lung. The risk of blood clots any place in the body can result in nthese blood clots traveling and can be fatal

While most blood clots form in one of the legs,as deep vein thrombosis they can also form in an arm, in the heart, or even an eye.

Yaz Has Risks for Heart Attacks

The birth control pill Yaz has been proven to raise potassium levels. This raises heart attack risks.

The Yaz related blood clot complications can be very serious and even fatal. At the vaginal Mesh helpline we are looking at all drugs and medical devices that har

Vaginal Mesh Helpline can finally report some comments from the medical community on the Vaginal mesh complications. Vaginal mesh helpline Listens to women every day with horror stories of the Vaginal Mesh. Vaginal mesh lawsuits are being filed nationwide in  Vaginal mesh multi district lawsuits

FDA warning on mesh held little surprise for urologists
Publish date: Jan 1, 2012
By:  Karen Nash
Karen Nash
Last summer, the FDA issued a strong warning about the dangers of complications from using mesh for the repair of pelvic organ prolapse and treatment of stress urinary incontinence. Between 2008 and 2010, the FDA said it received more a than 2,800 reports of complications associated with surgical mesh devices, generally placed transvaginally, when used for these indications.

The agency urged physicians to be thoroughly trained, to watch carefully for complications, and to make sure their patients are fully informed about procedures and their risks. In September, an FDA advisory panel concluded that the clinical benefits of using transvaginal mesh for prolapse repair have not been proven, but that available data support the safety and efficacy of first-generation suburethral slings for treating stress incontinence.

Urology Times wanted to know if urologists have changed their approach to prolapse and stress incontinence treatment as a result of the FDA's statement. Urologists say they aren't surprised at the warning, and it hasn't affected what they do, either because they weren't using mesh in the first place or because mesh can be used safely in the hands of the right surgeon.

Brian Cohen, MD, in Asheville, NC, has never used synthetic mesh for prolapse repairs.

Dr. Cohen
"I use all absorbable products, some Vicryl mesh, and Tutoplast by Coloplast, a product which is cadaveric fascia lata," Dr. Cohen said. "That's the way I learned in my residency and fellowship, and I've had good results. You don't have the worries you have with a synthetic mesh. I've seen plenty of patients with dyspareunia afterwards. There's no way to really deal with it."

In practice for 4 years, Dr. Cohen doesn't think the mesh should be banned, but he does think the risks outweigh the potential benefits.

"I just had an 85-year-old woman who had a prolapse repaired five years ago. I had to do a partial cystectomy in order to get the mesh out of her bladder," he said. "I take care of the problems; I'm not interested in causing them."

In Mammoth Lakes, CA, Tomi Bortolazzo, MD, agrees with that sentiment.

Dr. Aspera
"The FDA warnings haven't affected me," Dr. Bortolazzo said. "I work in a rural setting now, but when I worked downtown, I used to take care of all the complications from the gynecologists and other doctors doing all the TVTs with mesh. I even had a young, healthy patient spit mesh from her vagina. A lot of people just don't seem to react well to mesh, so now I use a Mylar sling that has pigskin."

Dr. Bortolazzo, a practitioner for 17 years, says she didn't like what she was seeing with the mesh long before the FDA came out with its statements, so she decided to avoid what she thought would be problems down the road.

"Now, I live in an area where everyone is an athlete and active. People don't like to put something foreign in their bodies," Dr. Bortolazzo said. "So I've been doing more and more autologous slings over the last 10 years."

Dr. Goldman
Although both Dr. Bortolazzo and Dr. Cohen are experienced with the complications, neither thinks the mesh should be banned.

"I'm sure there are places for it, perhaps in an older woman who is not sexually sexually active," Dr. Cohen said. "You'll get a longer-lasting repair."

"There are pros and cons," Dr. Bortolazzo added. "I occasionally use it, but I just don't think it's the best thing."

Other doctors question whether the problem is the mesh, as much as it might be surgical techniques or patient selection.