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Transvaginal mesh

Vaginal mesh Is a Global Pandemic, Vaginal Mesh lawyer

"Transvaginal Mesh Caused Five Years of Hell for Me, My Husband, My Kids"
February 8, 2012, 10:30:00AM. By Jane Mundy  Email to a friendEmail

    Sydney, NS: Leslie was 40 years old in 2007 when she had transvaginal mesh—a TVT sling—implanted. Since that time, she has had at least six MRIs and about a dozen CAT Scans. She has been in and out of the hospital on numerous occasions—including the renal unit for three months—and she couldn't have sex with her husband until last October. "Both my husband and I want to warn women about these transvaginal mesh devices," she says. "I don't think many people realize the devastation this mesh can create."

    "Transvaginal Mesh Caused Five Years of Hell for Me, My Husband, My Kids"Neither Leslie (not her real name) nor her doctor had any idea of the complications associated with TVT slings and transvaginal mesh devices. It wasn't until a year after Leslie's initial surgery when the FDA issued a safety alert, even though manufacturers like American Medical Systems and Bard, the maker of Avaulta, had received more than 1,000 complaints since 2005. Leslie knew her gynecologist was using the TVT but she knew nothing about it, other than that it would "stabilize and hold her bladder," according to her doctor.

    Within just a few weeks of surgery, Leslie had severe pain in her groin and a nasty urinary tract infection. Then she got lower back pain. Then it got a whole lot worse.

    "My blood pressure soared from 120/90 to 210/160 in no time at all, for no apparent reason," says Leslie. "Then I got hyper-pigmentation (not a rash) all over my face, neck and arms. A dermatologist told me it was systemic: something inside me was causing it but he had no idea what it could be. Then my face and ears would flush to beet red and my blood pressure would get so high I had respiratory problems. I couldn't breathe and my heart rate would go as high as 150 bpm when I was sitting down.

    "I went to ER so many times and they chalked it up to the urinary tract infection. Next up, I got edema and within three years I gained about 50 pounds (I am not a big eater and I don't eat junk food—in fact I was very athletic prior to the TVT surgery). My abdomen became so swollen it looked like I was pregnant. My voice became hoarse and then I got esophagus problems; I could never understand where this was coming from. Then I was sent to an ear, nose and throat doctor. Next came blurred vision and I lost my peripheral vision. An optometrist determined it was so bad I couldn't drive anymore. I lost my hearing in my left ear…

    "My husband and I were beside ourselves."

    So what does this all have to do with Leslie's transvaginal mesh surgery? It all links to her immune system. Unfortunately, it took a few years to figure that out. Neither Leslie nor the litany of specialists she saw clued in that the mesh erosion, which almost killed her, was the cause of so much pain, not to mention frustration and financial ruin.

    By December, Leslie's immune system was so poor that her family physician ordered a barium enema. The technician found a large polyp in her colon and she had a colonoscopy right away. They found four massive polyps—but what caused them? Leslie was told that large polyps usually turn into cancer, but they were benign—and that was the only good news she had, right up until the end of 2011.

    "I got so sick that and I couldn't walk up or down my stairs," says Leslie. "I couldn't do the laundry, couldn't do the dishes. I knew I was in serious trouble when I got half way up the stairs and my chest was so tight I couldn't breathe. I tried yelling to my 10-year-old to help me to bed. My husband raced home and I felt a bit better. The next morning I had to go for another barium swallow. This time the technician sent me to ER after he took my blood pressure: it was 240/150, but my respiratory rate was low. My kidneys were not working and no one could understand what was going on.

Vaginal Mesh lawyers are filing lawsuits for Vaginal mesh injury. This appears to be a global issue going all the way to sidney Australia.

The vaginal mesh lawsuits in the U.S.A are starting and you must get a vaginal mesh lawyer to protect your legal rights immediately.  

"An ambulance raced me to the renal unit of Sydney Hospital, where I stayed for three months. Everything was going wrong. At one time my cortisol levels were so high everyone thought I was going to die.

    "My husband and my kids were losing their minds.

    "I had every specialist you could imagine looking at me. They agreed it was systemic and a few doctors knew it was something auto-immune but no one figured it out."

    Leslie was booked for surgery to get cysts removed from her stomach but the surgeon told her she was too sick for surgery and advised that she go home, try to get better and come back in a few months. But when Leslie got home, she almost gave up.

    "Just before I decided to take all the pills on my bedside table, my friend, a nurse, came over and she, along with her neurologist friend, saved my life," explains Leslie, on the verge of tears. "I told her everything and she said, 'It has to do with the TVT surgery,' and insisted that I call a urogynecologist, who specializes in the care of women with pelvic floor dysfunction.

    "By this time we were financially devastated. My husband wasn't working because he was taking care of me, but we had no choice.

    "The urogynecologist did a pelvic exam and right away felt massive erosion. She asked if I had a mesh implanted. Then she did a cystoscopy and determined that the TVT mesh was cutting off the right ureter. Later, she found that the mesh was also cutting off the urethra.

    She said, 'You need surgery, you cannot have a foreign object in an organ.' She said the infection was so bad, 'It is going through your entire system, you need to get it removed now.' That was December 2010.

    "She found the mesh embedded in the urethra but she couldn't remove it. 'This is way above my skill level, I cannot do it,' she told me. But I had some relief from this surgery and I was referred to another specialist, a reconstructive urologist.

    "I had yet another surgery in October 2011. He said the mesh was 'In every place it shouldn't be,' eroded in my colon, bladder, pelvic floor. He said it was one of the biggest surgeries he had ever done.

    "Now I feel infection-free for the first time in five years, and I don't have to take anymore antibiotics. But I'm not out of the woods yet.

    "The reconstructive urologist noticed something on my urethra and he believes it is a piece of mesh. So I have to go back in three weeks. My bladder still isn't right; it takes a long time to empty and I can't hold my urine, I have no muscle left in my bladder. So I have to undergo yet another surgery.

    "I started to feel better and had enough energy to research transvaginal mesh online. I looked for FDA warnings and found so many women going through these problems. And I am furious.

    "My husband and I also found the TVM attorney online. Right now our fight is to get me better and my attorney can go after the TVT and TVM manufacturer. My attorney has all my medical records including the lot number of the TVT sling.

    "My kids and husband have lost so much because of this. Everyone needs to know that these companies are using us as guinea pigs. When I found out about the 501(k), how these medical device makers can put products on the market without clinical trials, I cried my heart out. How could the FDA allow this?

    "My attorney said it is OK for me to talk about this. I just want people to know the hell I have gone through; I want this taken off the market, forever."

Bayer Settles on Yaz, Opens Door to Yaz Lawsuits

The Yaz Helpline and Yaz Lawyers are pleased to announce  Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous Yaz blood clots

In addition to the Yaz settlements the Food and Drug Administration has placed new warnings on Yaz packaging du to numerus studies showing  a link between  Yaz and  blood clots, stroke and pulminery embolism.  This new warning comes as a reiied to medical practitioners who are prescribing Yaz. and have been concerned  about the impact of Yaz side effects. Thousands of women affected by Yaz side effects including Yaz deep vein thrombosis and Yaz gallbladder disease have filed suit against drug maker Bayer. In light of the new warnings and settlement offers Yaz lawyers are accepting cases for yaz.

Yaz  Hotline is here to help women harmed by yaz. Call and Speak to a female Social Worker and be connected to a yaz lawyer

Women's Yaz Hotline Launch is based on a recently issued FDA Warning for the drugs YAZ,Yasmin and Ocella.MDL lawsuits for Yaz,Yasmin are currently being filed. If you have experienced complications with Yaz,Yasmin or ocella,call the a Yaz, Ocella,Yasmin Lawyer Hotline Attorney today. The hotline is here for you 24/71 877 522 2123 You will speak to a medical social worker.
The Federal/State Yaz, Yasmin,  Birth Control Lawsuits are being filed  by Yaz Lawyers. The Yaz, Yasmine Hotline is here to answer your questions and connect you with a YAZ, Yasmin or Ocella lawyer.Referencing the New York Times," Yaz has been one of the top-selling birth control pills in the U.S and Canada., with nearly 20 percent of the market. In 2008, more than $600 million dollars' worth of Yaz was sold in the U.S. However, the television commercials advertising Yaz were of concern to the FDA and  the Attorney General because they implied that Yaz could be used to treat or cure symptoms for which it was not FDA-approved, such as:

  • Keeping a woman's mild acne at bay
  • Relieving symptoms of PMS (premenstrual syndrome):
  • irritability
  • increased appetite
  • moodiness
  • fatigue
  • headaches
  • bloating
  • muscle aches

Bayer agreed to make new commercials and print advertisements that did not promise more for Yaz than had been approved by the FDA, and that did not minimize the risks of Yaz birth control pills, which are many. Yaz is FDA-approved only for:
preventing pregnancy
treating the symptoms of PMDD (premenstrual dysphoric disorder) in women who are using Yaz as their contraceptive
treating moderate acne vulgaris in women who are using Yaz to prevent pregnancy
Safety Announcement
[09-26-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study (See Data Summary), FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.

Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.
Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. FDA previously communicated preliminary information about these concerns to the public on May 31, 2011 .
FDA has prepared a list of questions and answers to provide an overview of this potential safety issue. FDA will continue to communicate any new information to the public as it becomes available
Health Canada is currently reviewing the safety of Bayer Pharmaceutical’s birth control pills, Yaz and Yasmin, in an effort to determine if women who use these drugs are at an increased risk of developing life-threatening blood clots over women using different brands of birth control.

Yaz Lawyers of Free Legal Shield are pleased to  announce that contraceptive Manufacturer, Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous blood clots.

New Warning Labels on Yaz April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots.

Many Studies show Yaz linked to Blood Clots

 two new studies recently published in the British Medical Journal, which concluded that women ages 15-44 taking birth control pills containing the synthetic progestin, drospirenone, are more likely to develop blood clots deep in the veins of the leg (venous thromboembolism), than women using birth control pills containing the common progestin levonorgestrel. The studies reported that the risk of developing blood clots for women taking the drospirenone-containing pills may be two to three times greater than those who take other pills. Yaz is one of these drugs.

Yaz New Warnings  April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots

Yaz side effects include:
• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Blood clots
• Stroke
• Heart attack
• Gallbladder problems
• Pancreatitis
List of Drugs
Approved Oral Contraceptives containing Drospirenone

  • Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Ocella Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Safyral Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
  • Syeda Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Yasmin Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Zarah Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Beyaz Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
  • Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Gianvi Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Loryna Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Yaz Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Recent warnings have linked various birth control drugs and devices to serious injuries and even death:

  • Yasmin®
  • Yaz®
  • Ocella®

Injuries reported:

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Stroke
  • Heart Attack
  • Wrongful Death
  • Blood Clot Related Injuries
  • Kidney Failure
  • Gallbladder Injury/Removal

If you or a loved one has suffered from any of the harmful side effects of Yaz,Yasmin or Ocella such as blood clots, stroke or heart attack you may be entitled to file a Yaz,Yasmin,Ocella lawsuit against the manufacturer. Call us for a yaz lawyer with experience in birth control drug lawsuits toevaluate your claim. Many women around the United States have suffered from life-threatening Yaz,Ocella and Yasmin birth control side effects. The manufacturer can be held liable.
The Woman's Yaz Hotline is here for women suffering from Yasmin and Yaz  and Drospirenone side effects

Vaginal Mesh a Disaster for Women, Lawyers filing lawsuits

If you have a vaginal mesh and are experiencing complications you need to find a Urogynecologist and you must get a Vaginal mesh lawyer.

Ask Questions  and   Get Answers.   You are not alone and you are not imagining it. Over 300,000 women have vaginal mesh implants. They are failing in women across the country and lawsuits are being filed. Ask Qustions and get answers. These are not class Action litigations. They are multi district litigations. That means they are consolidated in certain states in certain courtrooms under one judge and that may not be the state you are in.  You need an experienced mass tort lawyer who will be appearing in court for you as a part of this multi district litigation. These are not class actions. You will have your case filed on an individual basis as an MDL. Ask quesions and get answers. You do not need a local lawyer. You do need a lawyer that is keeping your case and not referring it out to another lawyer to go to court for him.  Ask Questions and get answers. Choose your vaginal Mesh lawyer wisely.

What is the Vaginal Mesh?

Also known as a pelvic sling, bladder mesh, or transvaginal mesh, the vaginal mesh support systems are used to help with pelvic organ prolapse  as well as urinary incontinence  It is now known that they can cause serious internal injuries.  These vaginal mesh patch implants, manufactured by Johnson & Johnson , C.R. Bard, Boston Scientific, American Medical Systems, and others, may cause pain, infection, erosion, organ damage, and additional surgeries, and other vaginal mesh injuries.

If you have experienced vaginal mesh complications following pelvic organ prolapse surgery or stress urinary incontinence surgery, The  vaginal mesh support line   will offer help and direct you to a lawyer who  may be able to help you obtain significant compensation for the vaginal mesh problems you are experiencing.

Ask questions and get answers

Call us at 1 877 -522-2123 to speak with a female social worker and be directed to a lawyer.

Vaginal Mesh- History of the Problem

Between the years of 2005 and 2010, nearly 4,000 vaginal mesh injuries have been reported to the Food and Drug Administration.  In a 2010 article in the journal Obstetrics & Gynecology, researchers stated that they had to cease a vaginal mesh clinical trial early because of the higher-than-expected number of complications and injuries.  The trial was stopped when it was discovered that more than 15 percent of women who were implanted with vaginal mesh suffered vaginal mesh erosion within only three months of implantation.  As a result of numerous negative reports, the FDA issued a vaginal mesh warning to patients and physicians in 2011, cautioning that the risks of using vaginal mesh are so severe that alternative treatments should be considered.  It is now widely accepted that, in most cases, pelvic organ prolapsed can be treated without the use of vaginal mesh

What are the vaginal Mesh complications ?

  •     Erosion of vaginal tissue
  •     infection
  •     spot bleeding
  •     pain during sex
  •     lower back pain
  •     pain on one side
  •     depression
  •     Hardening of the vaginal mesh
  •     Infection
  •     Pain and discomfort
  •     Perforations of the bowel, bladder or blood vessels
  •     Recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
  •     Urinary problems
  •     Vaginal mesh erosion
  •     Vaginal scarring

Many women who have suffered injuries as a result of vaginal mesh have decided to file defective medical device lawsuits. This has become a middle district litigation and are being filed as MDl's are being filed. A product liability, multi  district litigation lawyer can review your case. Ask questions and get answers. call our Transvaginal mesh support line today.

Doctors Investigating Faulty Medical Devices Suing FDA

FDA SUED BY ITS OWN DOCTORS AND SCIENTISTS

Whistleblowers accuse FDA of spying, persecution

03 February 2012

The US Food and Drug Administration (FDA) is being sued by its own scientists and doctors who allege they were spied on and persecuted by the agency for expressing safety concerns about the approval of medical devices. This legal action has prompted an investigation by a key lawmaker in the Senate.
It's claimed that the FDA installed spyware to monitor personal email accounts

Iowa Republican Senator Charles Grassley – a powerful member of the judiciary committee that has jurisdiction over areas like civil liberties and constitutional law – has asked FDA commissioner Margaret Hamburg to provide details about who authorised the monitoring of employees and why some of the plaintiffs are no longer employed by the agency. Hamburg has until 17 February to supply her answers.

In the lawsuit filed on 25 January, six whistleblowers claim that the FDA secretly spied on them for two years. They say that the agency began its campaign of electronic snooping after the agency learned that they had written a letter to the president elect, Barack Obama, and his transition team in early 2009 detailing misconduct in approving unsafe medical devices. In that letter, the plaintiffs called the FDA 'fundamentally broken', and said its scientific review process for medical devices has been 'corrupted and distorted' by managers.
Soon after, the agency installed or activated spyware on the whistleblowers' work computers and also monitored their private emails, according to court documents. In addition, evidence suggests that the FDA took screen shots of the employees' computers and also intercepted their emails to and from staff members on key House and Senate oversight committees.
These actions appear to have continued even after the Office of Inspector General (OIG) at the FDA's parent agency – the Department of Health and Human Services (HHS) – denied the agency's request to take criminal or administrative action against the individuals. In a May 2010 letter to the FDA, the OIG concluded that the whistleblowers' communications were legally protected.
Chilling effects
The plaintiffs, who were all heavily involved in the FDA's safety review process, are seeking an injunction to stop the agency from pursuing what they say is an illegal spying campaign. Two of these whistleblowers still work at FDA and say that they face continued harassment, two were fired and another two did not get their contracts renewed, according to Stephen Kohn, the lead attorney for the plaintiffs.
'If you can target someone simply because they raise a legal, health or safety concern, that will have a chilling effect on any FDA employee alerting the public or Congress about matters of life and death,' Kohn tells Chemistry World. 'There is a lot of pressure on these scientists to approve the devices.' 
According to Kohn, the whistleblowers raised major concerns about 20 medical devices that involve, among other things, ultrasound and CT scan technology. Specifically, these reviewers said some of the devices could expose patients to radiation at levels up to 800 times that of a chest x-ray and they found that others couldn't appropriately detect cancers. Nevertheless, Kohn says the FDA approved 19 out of 20 of these devices that had been flagged.
'Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so, while also risking their professional careers, they are often treated like skunks at a picnic,' Grassley wrote in a 31 January letter to Hamburg, asserting that retaliation against whistleblowers 'should never be tolerated'.
Grassley said that certain employees, including members of the Public Health Service Commissioned Corps within HHS, are not covered under the US Whistleblower Protection Act, which leaves them vulnerable to retaliation. He says that this is a one of several loopholes in current law that should to be closed.
The FDA said it can't comment on personnel issues or any matters subject to ongoing litigation.
Rebecca Trager

 

 

 

 

 

 

 

 

 

 

 

 

 

Your Vaginal Mesh Lawyer, New Prolapse Mesh Guidelines

Updated Guidance for Use of Vaginal Mesh for POP
By Jamie L. Habib | December 23, 2011

In further response to the Safety Communication issued by the FDA in July 2011 regarding the use of vaginal mesh, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) jointly state that the use of vaginal placement of synthetic mesh for the treatment of pelvic organ prolapse (POP) should be reserved for high-risk women for whom the benefits may outweigh the risks.1 The College and the AUGS also state that there is an urgent need for development of a national registry to track outcomes for all current and future patients who receive vaginal mesh implants.

The specific recommendations of The College and AUGS for use of vaginal mesh include the following1:

 

• Continued audit and review of outcomes and the creation of a surveillance registry for all current and future vaginal mesh implants.

• Outcome reporting for prolapsed surgical techniques defining success, complications, and total reoperation rates.

• Surgeon training for vaginal mesh placement specific to each device, including surgical experience with reconstructive surgery and thorough understanding of pelvic anatomy

• Rigorous comparative effectiveness trials of synthetic mesh and native tissue repair and long-term follow-up.

•Patient counseling about alternative native tissue repairs and the permanent nature of synthetic mesh, as well as discussion of the risks, benefits, and alternatives to the procedure.

• Limiting use of POP vaginal mesh repair to high-risk women for whom the benefit may justify the risk.

• Adoption of new mesh products and devices only with clinical long-term data demonstrating equal or improved safety and efficacy compared with existing products and devices.

Vaginal mesh lawyers accepting cases for transvaginal mesh complications.

Contingency Lawyers-Injury Lawyers

Contingency Lawyers are Injury Lawyers  1-800-733-5342

What Are Contingency Cases ?

Some cases are typically charged fees based on “No recovery , No Fee ". This  includes Personal Injury lawyers, Wrongful Death, Medical malpractice attorneys, Workers Compensation lawyers, Social Security Disability lawyers, Labor and Employment,wage and hour claims, and class action litigation against pharmaceutical and Medical companies for drugs , malfunctioning surgical devices and orthopedic devices. Examples would be the depuy hip replacement,Avandia or Yaz,Actos,Transvaginal Mesh, and others

Fees are usually a percentage of the award plus costs incurred. The fee is contingent on the outcome. The lawyer will be paid only from the funds you receive in a judgment or settlement.

For all other cases, fees will vary.

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