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)

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, 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

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.

Vaginal Mesh Helpline and vaginal Mesh Lawyers San Fransisco and Los Angeles have expanded the California division due to increase in number of women in need of vaginal Mesh help in: Los Angeles, San Diego, San Jose, San Francisco, Long Beach, ,  Sacramento, Fresno, Oakland,Santa Ana, Anaheim, Riverside, Bakersfield, Stockton, Modesto, Chula Vista, and most of California. Out feedback form women callers points to the L.A area for sme of the besh Urogynecologists helping women.

Old L.A Times Story below

FDA continuing to review vaginal mesh implants
Monday, July 18, 2011
According to a Los Angeles Times report this month, the U.S. Food and Drug Administration has released an updated warning focused on surgical mesh that is implanted into women to help strengthen their vaginal tissue.

The FDA was quoted as saying that they have conducted a review of literature and reports that show little evidence that the vaginal mesh implants help pelvic organ prolapse. Not only did the reviews find little advantage to using the mesh implants, but they also found numerous risks.

The report states that in September the FDA held an expert panel meeting to discuss the future of the product. Right now, it’s estimated that around 75,000 women who used vaginal mesh were treated for pelvic organ prolapse.

Warnings began to pop up concerning the vaginal mesh in 2008, mainly because of numerous reports which began to arise after 2005. According to the Times article, the FDA warned doctors to get special training in the placement of mesh. Since the 2007 FDA warning, there’s been an influx in complaints relating to prolapse repair.

According to the article, medical devices are often cleared without the requirement of clinical trial data. With these limited restrictions, a number of different products which are considered similar to other ones can be approved for selling.

The FDA is set to continue overseeing these vaginal mesh implants in all forms, to see if they may run the same level of risk. The agency has been under criticism for a few years due to the approval process for medical devices

And yest today as we write we are still hearing Horrific stories from L.A and  SanFransisco women.

and they are sosting all over the internet: As we fount a San Fransisco Cry for help:

Please let me know what your surgery outcome was.  I am currently interviewing surgeons to remove most or all of my mesh.  Though I do not have exposed mesh, I have severe nerve damage from the mesh becoming detached 2 weeks after implant and falling on a large nerve area.  All the area is damaged, numb and I have severe pain there.  I am on Neurotin all the time.
I am so dissappointed in the physician that did this surgery, but I am also concerned now about selecting a new physician.  I alread spoke to one who admitted he cannot help me. EVidently it is far easier to place the mesh, but it is entirely a different thing to remove it. My physician said it could not be done.  If I don't get rid of this, I will never be able to be normal.  I have been unable to have relations with my husband now for nearly 7 months.  My vagina has altered since the mesh was placed and there is a large enough obstruction to have caused a cessation in intercourse.
I am frustrated, upset, and tired of talking to doctors, looking on the internet, and hearing, "Oh, yes, we do this".  I don't have any idea who I can trust.
Frustrated near San Franicisco

Vaginal Mesh Real Symptoms Include and Vaginal Mesh Problems Include:

• Pain
• Erosion of the mesh into the bowel Bladder or vagina
• Pain during sexual intercourse
• partner feeling the mesh
• infections
• spot bleeding
• lower vack, abdomin or pain on one side
• Depression
• sepsis for erosion int the bowel
• need for revision surgery or mesh removal
• difficulty in locating a sympathetic doctor

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.