Posts Tagged ‘Illinois’

J & J Sold Vaginal Mesh Implant After Sales Halt Order, Vaginal Mesh Lawyers Report

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

It appears J & J sold the vaginal mesh to unsuspecting doctors and victims even after they were ordered tp stop. So many women call us daily with so much pain and agony. These poor women were victims of a manudfacturer whi apparently put profits over people. There is nothing a fine or slap on the wrist can do to bring a womend life back to normal. We are reaching out to you. If you have not added your name to the vaginal mesh lawsuits you must now. We must obtain justice. See article below

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered
By David Voreacos and Alex Nussbaum on June 26, 2012

Johnson & Johnson (JNJ) (JNJ), the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court records.
The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.
“You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick, New Jersey-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”
The FDA cleared the device in May 2008 without ordering sanctions, after nine months of negotiations with J&J’s Ethicon unit. The company faces more than 1,400 lawsuits by women who say the mesh caused organ perforation, pain, scarring and nerve damage. Lawyers for the women say the device’s approval history could increase J&J’s cost to resolve the litigation.
“If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it,” Adam Slater, an attorney suing on behalf of 150 women, said in a phone interview. “It’s egregious that J&J was selling the device without clearance.”
Letter Unsealed
The 2007 letter was part of a group of documents filed under seal in state court in Atlantic City, New Jersey, and made public in May at the request of Slater, a partner at Mazie Slater Katz & Freeman LLC in Roseland, New Jersey. Lawsuits also are pending in federal court in Charleston, West Virginia.
J&J began selling (JNJ) the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.
The FDA disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter, Morgan Liscinsky, an agency spokeswoman, said in an e-mail.
J&J faced no sanctions because the FDA determined that the company applied the guidance in good faith and it “promptly complied” when the agency required a new application, Liscinsky said.
Fines, Injunctions
Sanctions for selling products without approval may include fines, injunctions against a company or senior managers and the seizure of illegally marketed devices, Liscinsky said.
The August 2007 letter was “only one part of an extended dialogue with FDA in 2007-08, and it is out of context,” Johnson said in the e-mail. “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.”
Henry G. Garrard III, a lawyer who represents women suing in federal court in Charleston, said the FDA’s failure to take additional steps to halt Prolift sales or to sanction J&J raises questions about the agency’s power to protect patients.
“Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC in Athens, Georgia, said in a phone interview.
“Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.”
Ordered Study
Surgeons thread mesh implants through vaginal incisions and use the devices to treat incontinence or pelvic organ prolapse, a condition in which weakened muscles fail to support organs. Almost 300,000 were used in U.S. women in 2010, the FDA estimated last year.
An FDA database of reported malfunctions, deaths and serious injuries shows the agency received 123 complaints about the Prolift from 2005 to May 15, 2008, when the device won clearance. The company said in a September 2007 letter to regulators that reported problems accounted for less than 0.5 percent of sales for both Gynemesh and Prolift.
An agency report in July found a fivefold jump in deaths, injuries or malfunctions tied to prolapse mesh inserted vaginally. In January, the FDA ordered J&J, Murray Hill, New Jersey-based C.R. Bard Inc. (BCR) (BCR) and other manufacturers to study organ damage and complications related to the products.

J & J has just removed the Gynacare of the market for four of the devices and changed the labeling for a fifth. They claim this not to be a recall and for financial reasons only. The vaginal mesh helpline can only say "how very interesting indeed".

New Study Regarding Vaginal Slings, Vaginal Mesh Update

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

There appears to be a new study that actually speaks positively about the vaginal sling.  This study concludes  that vaginal mesh slings reduce the risk of post-surgical incontinence.  However we know at the Vaginal Mesh Helpline that the by the real life  complications our suffering women callers are experiencing that the benefits do not appear to out weigh the "pain and suffering". According to research published in the New England Journal of Medicine on June 21, 2012 , women who undergo surgery with a vaginal mesh sling to treat post-operative stress urinary incontinence are less likely to experience incontinence a year later, but more likely to suffer a transvaginal mesh injury like an infection, urinary leakage, and major bleeding. How nice of them to see both sides of the story here.

University of Michigan researchers compared women who went through POP surgery and were implanted with a transvaginal mesh sling with those who went through the same surgery but were not implanted with the sling. The sling used in this study was the Gynecare TVT, made by Ethicon, a subsidiary of Johnson & Johnson. The device is made of surgical mesh and is designed to lift the bladder and relieve pressure to prevent incontinence. The Gynacare mesh has been pulled off the market for four of the mesh implants under the Gynacare name and the fifth has a new stronger label warning for implantation thru the abdomin only. This is  hardly a positive for the Gynacare Mesh. We all know that a manufacturer, whose stock is doing well, does not just pull a money maker off the market. Obviously the negative, as in lawsuits, outweighs  the positive.

However according to  the results of this study, the transvaginal mesh sling cut in half a woman's risk of subsequently developing incontinence. After three months, 23.6 percent of the women with the sling and 49.4 percent of those without it had urinary incontinence. Twelve months after surgery, 27.3 percent of the sling group and 43 percent of the non-sling group had urinary incontinence.

On the other hand, nearly 7 percent of those with the sling suffered bladder perforation, compared to 0 percent in the non-sling group, and 31 percent of those with slings experienced urinary tract infections, compared to 18.3 percent of those without slings. Finally, those with the sling also experienced bleeding complications (3.1 percent versus 0 percent), and incomplete bladder emptying six weeks after surgery (3.7 percent versus 0 percent).

Very interesting as we note the  announcement by Johnson & Johnson that they are discontinuing the Gynecare TVT Secure vaginal mesh. At the Vaginal Mesh Helpline we listen to women daily. They tell us their stories  of  serious, painful complications like infections, erosion, pelvic pain, urinary problems, bleeding , painful sexual intercourse and suurgery after surgery to get the mesh removed.

Cheryl Iglesia, M.D., of the Georgetown University,  has noted in a commentary  that the vaginal slings are  different from transvaginal mesh, which is often used to create broader support of pelvic organs. Slings are smaller and shaped like straps, about 1 cm wide and 10 cm wide, while transvaginal mesh sheets can span up to 10 cm wide and 20 cm long.

The study  further noted that though beneficial, vaginal slings are not without risk.  The vaginal mesh helpline is trying to locate doctors who can help women with the removal of the mesh and are advised to discuss the other options with their doctors, and  reconsider putting another mesh on top of the already failing one.

The Vaginal Mesh Helpline encourages women to step forward and pursue being a part of the current MDL litigations. A message must be sent to the manufacturers. We can help you locate a vaginal mesh doctor and first line vaginal mesh lawyer  who will not refer your case to  another lawyer because he is inexperienced in mass tort litigation. The vaginal mesh helpline does have very strict criteria and an interview process for any attorneys who wish to be involved with the helpline.

 

 

Vaginal Mesh Helpline Announces, Label Change For Vaginal Mesh Products

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

Vaginal Mesh Helpline and Vaginal mesh lawyers are reporting an important label change for Vaginal mesh products.

Vaginal mesh helpline reports that medical device manufacturer Johnson & Johnson announced a product label change to restrict the use of  the Gynemesh vaginal mesh  on June 4, 2012.* In a letter to the Court in the pending vaginal mesh MDLs, the company wrote: “Ethicon also plans to update the product labeling for Gynecare Gynemesh PS…to restrict the indication for use to the abdominal sacrocolpopexy procedure for the treatment of pelvic organ prolapse.” In other words, the product would no longer be indicated for use in transvaginal surgeries and would only be inserted through an incision at the bottom of the abdomen.

J&J also informed the Court that they would cease “commercializing” four of its Gynecare vaginal mesh systems. According to The New York Time, the company maintained that the end of sales was not based on safety concerns: “but was based on the products’ commercial viability ‘in light of changing market dynamics, and is not related to safety or efficacy.’”*** However other reports state J & J has opted to remove the mesh form the market due to concerns of injury.

 Ethicon is changing the label so that the product is only implanted through the abdomen rather than the vagina . This is interesting a the vaginal implanted mesh have caused the most injury. There appears to be differing views in the different news reports.

We would hope all mesh products would be pulled but, this is a good first step. It does not,however, bring justice to the women who have suffered and had their lives destroyed by these mesh products. If you have a mesh, have had your mesh removed, adjusted or have mesh complications you must file a mesh lawsuit. The statute of limitations for many states is running close. We want to hear specifically from women who have been rejected by a vaginal mesh law firm for their mesh lawsuit. We may be able to help you. Do not give up.

 

Vaginal Mesh J & J,Discontinued Sales of Vaginal Mesh Products

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

The vaginal mesh helpline is keeping women updated .J & J called for a Global discontinuation for their vaginal Mesh products. Vaginal Mesh helpline feels  this is a  wonderful development . Atleast some of the J & J  surgical mesh devices won't be on the market  hurting more women. That still does not help the thousands of women suffering.

Johnson and Johnson (J&J) recently announced that they would end sales of versions of surgical mesh products that were used to decrease the intensive pelvic discomfort of women; the decision was made following a number of complaints as well as reports of injuries and deaths.

The surgical mesh products in question are implanted in women to help improve damaged or weakened  vaginal wall tissue and to offer support for those who had pelvic organ prolapse (POP). POP is diagnosed in patients where the tissue holding the pelvic is weak, becoming stretchy and  weak in the vagina. Prolapse can occur in patients who have undergone childbirth, menopause, or a hysterectomy. The mesh was also used to assist those with stress urinary incontinence, which is a condition with a severe overactive bladder. Mesh has also been used for bladder and bowel prolapse.

On Tuesday, June 5, J&J spokesman Matthew Johnson stated that the company asked the U.S. Food and Drug Administration (FDA) if they could stop the sales of four related products within the next 120 days. This time period would allow hospitals and surgeons to find suitable alternatives. The product liability litigation is currently overseen by Judge Carol Higbee of New Jersey Superior Court in Atlantic City and federal Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia, including lawsuits involving Boston Scientific Corp and C R Bard Inc.

On Monday, June 4, the Ethicon division of J&J sent a letter to Higbee and Goodwin describing the request the company had made to the FDA regarding the discontinued sale of the mesh products. J&J also asked that the requirements for other studies on Gynecare products be suspended. Previously in January, the FDA had requested more studies be done on the vaginal mesh products.

“Ethicon has no present intention to commercialize these products in the future,” the company commented in a letter described in a Reuters article.

According to the FDA, in 2010 7,500 females had mesh repairs for POP and around 200,000 patients had transvaginal repairs for stress urinary incontinence. The FDA also stated that there were more than 1,500 cases that reported malfunction with the mesh between 2008 to 2010, including situations where the mesh eroded into the vagina or caused internal bleeding and infection. In recent years, people have sued the device makers of the surgical mesh products, alleging organ damage and other similar injuries due to the devices. There are currently thousands of lawsuits pending against Ethicon.

Over the next three to nine months, J&J has stated that it will discontinue sales of the products like Gynecare Prolift Pelvic Floor Repair System, Gynecare TVT Secur System, and Gynecare Prosima Pelvic Floor Repair System on a region-to-region basis in its global markets. The company will end sales as a result of negative publicity about the vaginal mesh devices and not due to the lawsuits.

“This is not a recall; it’s a global discontinuation,” Johnson said.

The decision by J&J could also be due to the company’s desire to prevent more lawsuits against vaginal mesh devices. Gynacare may have been the easiest one to drop from a purely business vantage point.

“I think the timing of everything is going to make it very hard for them to convince the jury that they don’t believe safety isn’t tied to their decision (to discontinue),” J. G.  who is representing some of the women suing the mesh makers, noted in the Reuters article. “(And) from our perspective, this is a fantastic development … We’re happy (the surgical mesh devices) won’t be on the market and hurting more women.”

According to the Wall Street Journal, the decision to cut the surgical mesh products, sold under J&J’s Ethicon unit, follows actions taken on other problematic products. The products that have had manufacturing problems include the bottle caps of children’s Tylenol and other over-the-counter medication, as well as DePuy hip replacement implants.

Four vaginal mesh implant products  .

Ethicon markets five different vaginal mesh products, and sales of four models –

Prolift, Prolift+ M, TVT Secur and Prosima – will be ended on a region-by-region basis by the first quarter of 2013.                                                                                                                                                                                                                    The fifth product – Gynemesh – will remain on the market for abdominal implantations only, with revised labeling to indicate its restricted use.

This news highlights the fact that the pressure hundreds of lawsuits filed by women across the country has forced the first multi-national corporation to acknowledge the problem and stop hurting more women. Ultimately, the actions of woman who come forward and file suit will continue to have a very significant effect on the other manufactures of vaginal mesh, and help prevent thousands of additional women from being injured.

Instances of vaginal mesh failure continue to occur in the over 75,000 woman who have received the procedure. If you've been injured as a result of a defective vaginal mesh implant, please contact us as soon as possible to discuss your case and learn how the law can work for you. Remember the stautes are running close in many states. We do not want you to be left out.

Source: redOrbit (http://s.tt/1dtl1)

Bladder Sling Helpline, Bladder Sling Lawyer

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Information

The Vaginal Mesh Helpline, Bladder Sling Helpline wants women to understand that their are a variety of Mesh implants out there. Most of them are mesh but have names that may be confusing to you. Although most of the advertisements you have been seeing on T.V say vaginal mesh, the Bladder Sling is also a vaginal mesh implant. There are current Bladder sling lawsuits for bladder sling surgery complications.

The complcations associated with a bladder sling surgical procedure are siminliar to vaginal mesh complications. including : infections, pain, bladder mesh erosion and recurrence of urinary continence. Women are filing  bladder sling lawsuits. .

Stress Urinary Incontinence Was Meant To Be  Treated By  Bladder Sling Surgery

Many women  suffer  from  stress urinary incontinence. This is simple SUI or leakage from a cough or sneeze. This is usually caused by the aging process, loss of estrogen, childbirth or injury.

Urinary incontinence, vaginal sling procedures are being used however, women have been experiencing severe complications from the bladder sling device. The severe unrinary incontinence from a failed Bladder Sling has made it difficult for women to enjoy life, keep a job or follow a simple daily routine,

Vaginal sling procedures  were meant  to  help control stress incontinence, urine leakage that can happen when you laugh, cough, sneeze, lift things, or exercise.  You may have difficulty holding urine and just have to get to the ladies room fast when out and about in your normal daily routine. They help close your urethra (the tube that carries urine from the bladder to the outside) and the bladder neck (the part of the bladder that connects to the urethra).

Vaginal sling procedures  causing the problems and resulting in bladder sling lawsuits use:
Man-made (synthetic) material

  •     Transobturator or TOT sling
  •     Tension-Free Vaginal Tape or TVT sling, Boston Scientific TVT Sling

A supportive sling is placed around the back of the urethra to help lift it back into its normal position. Incisions in the thighs make it possible for the sling’s insertion and the sling is kept in place by the abdominal wall. Serious complications have arisen and women are suffering

The Bladder Sling Lawsuits are Just Another Part of the Huge Nationwide Vaginal Mesh Lawsuits. Or in other words if what you have implanted is not saying "Mesh" do not assume that is it is not part of the mesh devices and bladder mesh implants lawsuits currently tsaking place. It is important to call the Vaginal Mesh Helpline and find out.

 

 

Vaginal Mesh Helpine, Seeking Women With Mesh Symptoms For legal Action

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

Vaginal Mesh Helpine, Seeking Women With Mesh Symptoms For legal Action, Statute of Limitations Notice
Vaginal mesh helpline Speaks to women every day who should be taking legal action for a failed vaginal mesh. Many Do not even Know their symptoms are from the mesh and need help. We are here to help you

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Jun 04, 2012 – Vaginal mesh Helpline announces we want to speak to every woman with a vaginal mesh to discuss the Multi District litigation currently taking place and assist in filing a Vaginal Mesh Lawsuit. The clock is ticking and your state's Statute of Limitations may be running close. We do not want you to be left out. You must see a doctor and get confirmation you have a failed mesh and begin the process of filing a Vaginal Mesh Lawsuit immediately. Some states have only a few months left. Call the vaginal mesh helpline today if you have been to a doctor and have been told you need revision surgery or mesh removal or have had revision surgery or a mesh removed.  Call us if you have not been to a doctor and have symptoms of severe pain,pain during sexual intercourse, increased urinary incontinence, inability or difficulty in voiding, infection, bleeding, and the other symptoms presented on vaginalmeshhelpline .com "the pink site". We do not want any women to be left out of getting justice for the pain you have been thru. We will locate a vaginal mesh lawyer for you and give you guidance for locating a doctor.
Remember Every state has its own time limit for filing lawsuits called the Statute of Limitations.  , the manufacturers of the vaginal mesh implants have a right to have lawsuits dismissed or decided in their favor regardless of the injuries if the lawsuit is not filed in time to comply with the statute of limitations. We must hear from you today . 1 877 522-2123

Vaginal Mesh and Colonoscopy, Vaginal Mesh Helpline, Vaginal Mesh Lawyer

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Information

The Vaginal Mesh helpline has been receiving calls from women concerned about getting a colonoscopy while having a vaginal mesh. Although we cannot give medical advise we can present an article we have found:

US National Library of Medicine National Institutes of Health:
Case of rectal migratin of mesh after TVM (tension-free vaginal mesh) operation.

The Department of Urology, Kurashiki Central Hospital.

A 64-year-old woman presented with recto-cutaneous fistula after tension-free vaginal mesh reconstruction using polypropylene mesh for pelvic organ prolapse. Eleven months after the operation, an ulcerative lesion with stools smell secretion developed in the left hip. Magnetic resonance imaging and colonoscopy revealed a migration of the left arm of the mesh and a recto-cutaneous fistula. The patient underwent excision of the infected mesh and rectal wall closure together with transient colostomy. After 8 months, colonoscopy revealed a new migration of the mesh in the rectum, which was also removed. The colostomy was closed one year later and rectal erosion has not reccurred since then. The possibility of developing a rare but severe mesh-related complication as presented here should always be kept in mind.

We have had a number of callers have a Doctor stop the colonoscopy due to mesh erosion. The idea of an MRI makes sense to us. You also might want to go to a Urogynecologist first to assess your individual mesh circumstances before proceeding. We currently are working with a number of vaginal mesh lawyers who are accepting vaginal mesh cases as a part of the multi-district litigations. Please keep in mind  that in the female system the bladder bowel and Uterus are a tight knit system when making any decsions for any procedures. Seek medical advise and a second opinion if necessary.

FDA May Vaginal Mesh Meeting, Vaginal Mesh Helpline Reports

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

Vaginal Mesh Helpline offers support, information, reviewed vaginal mesh lawyers and urogynecologists for women injured by vaginal mesh implants. The the inaugural U.S. Food and Drug Administration ("FDA") Patient Network Annual Meeting,  took place on May 18, 2012. The meeting featured presentations from FDA experts and open discussions with patients and advocacy groups regarding the FDA drug and medical device approval processes. Speakers from numerous FDA departments outlined FDA processes and goals, and solicited audience input with questions and answers at the end of each presentation.* One attendee asked about how the FDA determines classification levels for medical devices and how the FDA tests the devices to see if they are safe. The FDA has recently come under fire given the widespread controversy over its expedited 510(k) approval process, which granted market approval for both transvaginal mesh implants and all metal hip implants.

FDA Wants To Better Monitor Patient Feedback on the Vaginal mesh Implants.

The Vaginal Mesh Helpline is hopeful that  the FDA will act on the results of the discussion on its drug and device approval policies and solicitation of  patient input for these important issues, especially in light of the recent DePuy hip recall and FDA warnings concerning vaginal mesh implants. The vaginal mesh helpline has spoken to hundreds of  women  with injuries stemming from  the vaginal mesh and the stories we hear are horrific. We encourage women to make adverse incident reports with the FDA regarding their complications from the prolene mesh.

Meeting Overview Focus Vaginal Mesh and DePuy Hip Replacement

U.S. Food and Drug Administration Inaugural Patient Network Annual Meeting, hosted by FDA's Office of Special Health Issues (OSHI) in collaboration with the Center for Drug Evaluation and Research (CDER), the Center for Biologics Research and Evaluation (CBER), and the Center for Devices and Radiological Health (CDRH).

This meeting was held to allow FDA to gain a greater understanding of how patients define and perceive benefits and risks related to medical products. The FDA Patient Network hosted this one-day meeting to:

  •     review the drug and medical device regulatory processes;
  •     discuss where patient input is practical and most valuable; and,
  •     explore practical approaches to collecting meaningful patient input.

The meeting included a series of presentations, exercises, and panel discussions to facilitate a conversation with the patient community about these important topics. FDA asked patients and other interested parties to consider specific questions, posed in a 4/19/2012 Federal Register Notice, designed to frame discussion at the meeting.

Working with Patients to Explore Benefit/Risk: Opportunities & Challenges

Video Recording of the May 18, 2012 event:

Part 1

    Keynote Address Stephen Spielberg, M.D., Ph.D., Deputy Commissioner for Medical Products and Tobacco
    Drug Development: Laws, Regulations, Statutory & Regulatory Limitations Janet Woodcock, M.D., Director, CDER

Part 2

    Drugs and Biologics Development 101 Robert Yetter, Ph.D., Associate Director for Review Management, CBER
    Devices 101 Peper Long, Associate Director, External Relations, CDRH
    Drugs, Biologics and Devices Question and Answer
    Richard Klein, Director, Patient Liaison Program, OSHI (moderator)

Part 3

    Benefit-Risk Framework Patrick Frey, Director, Office of Planning and Analysis, CDER
    Patient-Focused Drug Development Theresa Mullin, Ph.D., Director, Office of Planning and Informatics, CDER
    Making Benefit-Risk Determinations Peper Long, Associate Director, External Relations, CDRH
    Patient Risk Tolerance Survey for Obesity Devices Martin Ho, M.S., Division of Biostatistics, Office of Surveillance and Biometrics, CDRH

Part 4

    Patient Risk Tolerance Survey for Obesity Devices Martin Ho, M.S., Division of Biostatistics, Office of Surveillance and Biometrics, CDRH (continued)
    Discussion of Federal Register Notice Questions
    Patient Perspectives Panel & Audience Discussion James Valentine, M.H.S., Project Manager, FDA Patient Network, OSHI (moderator)
    FDA Reaction Panel James Valentine, M.H.S., Project Manager, FDA Patient Network, OSHI (moderator)
    Closing Remarks Richard Klein, Director, Patient Liaison Program, OSHI

The vaginal mesh helpline is hoping that something will come of these meetings and some action will be taken to protect women from this pandemic that has befallen them called the vaginal mesh. Women are suffering while meetisng take place. Lives are being ruined, jobs are being lost do to medical disability form the mesh and homes are going into foreclosure. The mesh has broke up marriages and left women confused, feeling alone and in despair about their lives after the vaginal mesh.Doctors have been insensitve about their mesh pain and they are having trouble getting honest treatment. We hear horrific stories on a daily basis and hope the talking will stop and action will begin. If you are having complications they are real and you are not alone. Call the vaginal mesh helpline today.

 

 

Social Security Disability,The Vaginal Mesh, Vaginal Mesh Helpline

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Information

I have heard so many horror stories of women unable to work and losing their jobs because of the Vaginal Mesh Injuries they have indured that I decided to look at SSD, social security disability and the chance for women getting benefits. I want to share what I have found with my readers.

 This is An Overview of  Social Security and SSD benefits

Social Security is based on the concept that while you were working , you paid taxes into the Social Security system, and  now that you have become disabled , from the mesh, you can receive monthly benefits that are based on your reported earnings. The question will be, as we are finding out, will a doctor back you up and say you are disabled from the mesh?

This is a very unfortunate way to have the  money you put into the Social Security system be reimbursed to you. The money you contributed is put into a huge trust for everyone and from this trust Social Security  will hopefully pay you your benefits from your inability to work as a result of this mesh implant.

You may have to appeal the  Social Security Disability Claim

Appealing a Social Security disability claim is a not an easy process. But, with the help of a good social security disability lawyer you may just be able to collect benefits and perhaps be able to get the medical intervention you so badly need at this time. It is worth trying..You would need an experienced Social Security Disability lawyer. You may have as battle on your hands. Social Security Disability lawyers do not charge for their services. They fall under the category of contingency lawyers.

 

Social Security Disability Insurance

Social Security Disability Insurance (SSDI), the primary kind of Social Security Disability benefit, pays benefits to individuals who become disabled and are unable to work for a year or more.  Here is where you may be able to get some help. This may be an even easier route. Social Security helps disabled persons return to work, and will continue to pay disability benefits until he or she is able to work again on a regular basis. This may be after the mesh is removed. Here may be a way to help you achieve that and locate a doctor that can help you.

I would think it is worth a try.  Good luck…The Vaginal Mesh Helpline.

 

The FDA Did Not Approve Some of These Mesh Implants, Vaginal Mesh Lawyers Filing Lawsuits

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

The Vaginal Mesh Helpline is speaking to women daily as well as husbands and family. What the all have in common is suffering from a failed mesh. Yes, they are all suffering together. Our goal is to keep you updated. Here is some new vaginal mesh news.

FDA Didn’t Approve Vaginal Mesh Products
Elise Kramer | May 30th, 2012 | Posted in Vaginal Mesh Lawsuits

Some evidence has surfaced that indicates that device manufacturer Johnson & Johnson did not have Food and Drug Administration approval for the transvaginal mesh product they were selling for three years. This could mean a new wave of litigation might be filed against the drug manufacturing giant, as many women have already been wounded by vaginal mesh devices that have caused serious complications for them. According to a report by Bloomberg.com, the device manufacturer began selling the Gynecare Prolift vaginal mesh device in March of 2005, which was three years to the month before the device was approved by the Food and Drug Administration, which took place in March of 2008. Between the time it was released on the market until it was approved, the FDA received 123 reports of complications associated with the Gynecare Prolift device.
Vaginal mesh complications concern patients

Vaginal mesh devices are ways of treating stress urinary incontinence and pelvic organ prolapse, which are both conditions dealing with the weakening of pelvic organs. Complications associated with the devices, however, can cause even further problems, including recurrence of the original problems, urinary tract infections, and mesh erosion. Hundreds of women—more than 550—have filed lawsuits after suffering from transvaginal mesh complications. They are hoping to gain compensation that would help cover medical bills they have incurred due to their side effects.

The Food and Drug Administration reported a fivefold increase in complications associated with vaginal mesh devices, including deaths and malfunctions, in July of 2011. This decision resulted in an advisory panel for the organization recommending that such devices should be reclassified as “high risk” devices that are in need of human testing before it can be determined whether or not they are safe.
FDA process questioned

The Food and Drug Administration was apparently unaware of the Gynecare Prolift device before 2007, at which point the device manufacturer sought to approve a similar product. The device, according to Johnson & Johnson, did not need explicit FDA approval because it was already similar to a product that had already been approved for the market, and therefore didn’t need to be checked individually. Many plaintiffs who have filed a vaginal mesh lawsuit do not believe this should be the case and have taken legal action.

If you or someone near and dear to you is suffering from a vaginal mesh implant call us. Our medical social worker is here to help you.