Watson will now produce a generic Yaz. Yaz has been shown to be harmful to many women. Just another drug or medical device, like the vaginal mesh, bladder sling and Mirena IUD, that has been harmful to women. Watson cannot be sued for Generic Yaz. This is an outrage. Again, another drug  harmful to women? Women beware. This new , not so new, drug is called Vestura a registered trademark of Watson Pharmaceuticals.

Watson Increases Generic Count, Vestura is indicated for the prevention of pregnancy. Vestura is generic Yaz

By: Zacks Equity Research
January 20, 2012
 

Watson Pharmaceuticals Inc. (WPI) added another drug to its list of generic launches as it announced the launch of Vestura, the generic version of Bayer’s (BAYRY) oral contraceptive, Yaz. Vestura is indicated for the prevention of pregnancy and the treatment of moderate acne in women who are at least 14 years old.

According to IMS Health, the total US sales of Yaz and its generic versions amounted to $510 million for the twelve months ended November 30, 2011.

The US Food and Drug Administration (FDA) had approved the company’s abbreviated new drug application (ANDA) for Yaz’s generic in November 2011. We note that Watson Pharma and Bayer are currently involved in a patent litigation lawsuit related to this product.

Other Generic Launches…

Watson Pharma has been very active over the last few months with at least one of its generic products hitting the market every month.

Last month, Watson Pharma announced the launch of a generic version of Teva Pharmaceutical Industries Ltd.‘s (TEVA) LoSeasonique. The drug is used for the prevention of pregnancy. The launch of the generic drug took place as a part of a settlement agreement between the two companies.

Since Watson Pharma was the first company to file an ANDA for the generic version of LoSeasonique, it got 180-day marketing exclusivity for the generic drug.

Moreover, in November 2011, Watson Pharma announced the launch of an authorized generic version of Pfizer Inc.’s (PFE) drug, Lipitor. Lipitor is approved for use as an adjunct to diet to reduce elevated total cholesterol, LDL (bad cholesterol), triglycerides and increase HDL (good) cholesterol.

According to the supply and distribution agreement, Pfizer will manufacture and supply all dosage strengths of the authorized generic product to Watson Pharma, who, thereafter, will market and distribute the same in the US. In return, Pfizer will receive a share of the net sales from Watson Pharma. The agreement, which runs until November 30, 2016, is expected to add about 48 to 53 cents per share to Watson Pharma’s 2011 earnings.

We expect the new generic product launches over regular intervals to help drive the company’s Global Generic segment’s sales, which climbed 39% to $802.5 million in the third quarter 2011. Additionally, we expect Watson Pharma’s 2011 results to be positively impacted by the sales of its generic version of Johnson & Johnson’s (JNJ) Concerta, launched in May 2011.

It is amazing to me how many dangerous drugs and medical devices are having an affect on women. The vaginal mesh Helpline hears from women thru-out the country regarding their horiffic ecperiences with these mesh devices. Yet, there are so many other drugs and medical devices that are hurting women. The Mirena birth control device, Yaz, Yasmin, Ocella, The DePuy Hip Replacement, metal on metal hip replacements, Zimmer Duram Cup, Breast Implants, Cytotec, Topamax and others,

Mirena Birth Contol device

The Mirena Birth control device has caused amongst other side effects: Miscarriage, Risk Of Infertility, Intrauterine Pregnancy, Streptococcal Sepsis, Pelvic Inflammatory Disease Cervix, Severe Pain, Contraceptive Perforation and other side effects.

Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of the Mirena device, including perforation of or imbedment in the uterus.

Bayer actually marketed Mirena as a way  women could simplify their lifestyle. One of the ways it did so was through "Mirena Parties." Working with the social networking site Mom Central, Bayer created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. Bayer was eventually warned against this. The stories have heard and read regarding this divice are horrific.

WARNINGS AND PRECAUTIONS
Ectopic Pregnancy
Evaluate women who become pregnant while using Mirena for ectopic pregnancy. Up to half of pregnancies that occur with Mirena in place are ectopic. The incidence of ectopic pregnancy in clinical trials that excluded women with risk factors for ectopic pregnancy was approximately 0.1% per year.
"Tell women who choose Mirena about the risks of ectopic pregnancy, including the loss of fertility."

Other Adverse Effects from the use of Mirena:
Sepsis, ovarian cyst formation, breast cancer, damage to conceived children, PID, embedment, amenorrhea, perforation of uterine wall or cervix may occur during insertion

Cytotec (Misoprostol)

It is estimated that in about 200,000 births in one year, Cytotec was used to stimulate delivery. This is where most of the problems with this drug, including birth defects have incurred.  The purpose of the drug was for the prevention of ulcers, but it has also been used in abortions. Brain damage to infants is of particular concern.

Yaz, yasmin Birth Control Pills

The review was prompted by 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.

Potential Yasmin and Yaz side effects may cause:

•     Heart Attacks
•     Strokes
•     Cardiac Arrhythmias
•     Blood Clots
•     Deep Vein Thrombosis (DVT)
•     Liver damage
•     Anaphylactic Shock
•     Pulmonary Embolism (PE)
•     cervical cancer
•     severe migraines
•     Hair loss
•     Gallbladder Disease
•     Death

List of Drugs similiar to Yaz and Yasmine

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

Topamax

Topiramate, the generic form of Johnson & Johnson’s anti-seizure drug, Topamax, is under fire from the Food & Drug Administration for its birth defect risks, Reuters reports. The medication is prescribed to patients suffering from epilepsy, and more popularly, to consumers with chronic migraine headaches. Topiramate has recently been combined with other drugs to battle obesity and bipolar disorder. More than 4.7 million prescriptions for Topamax were filled in the United States from 2007 to 2010, bringing in approximately $600 million worldwide last year.

In March 2011, the FDA issued a warning that Topamax side effects may increase the risk of oral cleft birth defects, such as cleft lip and cleft palate, among babies born to mothers who took the drug during the first trimester of pregnancy. As a result of inadequate warnings previously provided, many women were not aware they may be exposing their baby to a potential risk of Topamax birth defect.

If one looks att all the current medical devices and drugs with complications the effects on women are staggering:?  A new report says women are most likely to be injured.

FOSAMX EFFECTS WOMEN

The .Long-Term  use of Fosamax  has been shown to more then double the Risk of Femur Fractures Among Older Women.

An article in an issue of the Journal of the American Medical Association reports that long-term use of Fosamax and other bisphosphonate drugs by older women more than doubles their chance of suffering femur fractures.  This side effect is particularly disturbing in light of the fact that Fosamax and similar drugs are prescribed to strengthen the bones of women with osteoporosis.

The article summarizes a study of Canadian women aged 68 years and older who had taken oral bisphosphonates like Fosamax for five years or more.  The study found that women who had taken Fosamax and related drugs for five years or longer were 2.74 times more likely to suffer a femur fracture than women who had taken the drug for only 100 days or less.  In fact, the study concluded that more than half of the femur fractures among women who had taken bisphosphonates for five years or more were attributable to their use of bisphosphonates.

A number of Fosamax lawsuits seeking financial compensation have already been filed against Merck & Co. for injuries caused as a result of serious

TRANSVAGINAL MESH AND RELATED MESH PRODUCTS

Manufacturers of Mesh Products Include:

Johnson & Johnson

    Ethicon TVT
    Gynecare TVT
    Gynemesh PS
    Prolene Polypropylene Mesh Patch
    Secur

Bard

    Avaulta Plus BioSynthetic Support System
    Avaulta Solo Synthetic Support System
    Faslata Allograft
    Pelvicol Tissue
    PelviSoft Biomesh
    Pelvitex Polypropylene Mesh

American Medical Systems or AMS
SPARC
Boston Scientific

    Advantage Sling System
    Obtryx Curved Single
    Obtryx Mesh Sling
    Prefyx Mid U Mesh Sling System
    Prefyx PPS System

Vaginal mesh implants have been used to correct uterine prolapse and incontinence but the complications are effecting women thru-out the United States, Canada and the U.K.

complications include:

•         Erosion of vaginal tissue can result from a vaginal mesh
•         Hardening of the vaginal mesh
•         Infection is a serious vaginal  mesh-patch complication
•         Severe Pain and discomfort
•         Perforations of the bowel, bladder or blood vessels
•         Recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
•         Urinary problems and more severe incontinence
•         painful sexual intercourse
•         Vaginal mesh erosion
•         Vaginal scarring

The transvaginal mesh Continues to effect women and alter the lives of Women and

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

Metal On Metal Hip Replacements like the DePuy and Zimmer

Women are reporting more problems, and a higher failure rate, with the DePuy ASR XL Acetabular hip replacement system than men. It turns out they're also more prone to some of the serious side effects of the poorly-designed implant, including metallosis.

Statistics show individuals with a small stature, such as women may be more susceptible to failure of DePuy ASR hip implants. .

Breast Implants

Breast Implant Lymphoma

In January 2011, The U.S. Food & Drug Administration (FDA) advised that women who had received breast implants should notify their doctors of any changes in their breasts because of a possible association with a rare type of lymphoma. In breast implant patients, ALCL has occurred in the scar capsule adjacent to the implant.

Symptoms of breast implant lymphoma include:

• Pain
• Lumps
• Swelling
• Asymmetry that developed after their initial surgical sites were fully healed

Historically, women are more often exposed to dangerous medical products and medical negligence than men. Some medical malpractice claims, for instance, are unique to women—like obstetrical malpractice and sexual assault by health care providers. In addition, women suffer harm from gender-specific products such as breast implants, birth control pills, osteoporosis medications and birth control devices like IUDs.

In the age of prescription drugs and antidepressants, where drugs are administered over-the-counter without any major restrictions, more people are dying each year from medications than from traffic accidents. A recent L.A. Times article looked at the impact prescription drugs have upon American society, and their dangers if used in certain combinations.

In 2009, prescription drugs factored in the deaths of over 37,000 people. Less people died in motor vehicle accidents that year, which was a  new phenomenon, according to the U.S. Centers for Disease Control and Prevention.

The vaginal mesh helpline hopes that the new bill coming before congress will protect women from manufacturers whose products slip thru and eventually are either recalled or end up with warnings. These drugs and medical devices are hurting women.

On December 14, a bipartisan group of U.S. Senators introduced legislation that would give the U.S. Food and Drug Administration (FDA) the power to force medical device companies to track their medical devices, including pelvic mesh implants, after they’ve been sold or used, according to the New York Times.

The newspaper reported that a trio of senators also wrote letters to five of the nation’s largest medical device manufacturers, including pelvic mesh manufacturer C.R. Bard, Inc., requesting information on how the companies handle recalls and post-marketing surveillance of their products.

Garrard currently serves as lead counsel for the plaintiffs in the In re Avaulta Pelvic Support Systems Product Liability Litigation (MDL No. 2187), which involves claims against C.R. Bard, Inc., and subsidiaries of Covidien PLC relating to those companies’ women’s pelvic repair products.

“The problem is that too many defective and dangerous medical devices make it to the market in the first place under the FDA’s 510(k) process because they are never demonstrated to be safe or effective before being cleared for sale,” said Garrard, the managing partner of the Georgia law firm of Blasingame, Burch, Garrard & Ashley, P.C.

“After they get into the marketplace, the companies selling these products need to do more to identify problems early on in order to prevent patients from suffering the serious damage these products can cause,” he said. “This legislation and the information requested by the senators would be positive steps towards achieving that goal.”

According to the New York Times, the bill sponsored by Sens. Herb Kohl (D-Wisconsin), Richard Blumenthal (D-Connecticut) and Charles E. Grassley (R-Iowa) would apply to medical devices that were cleared by the FDA under the 510(k) process, such as surgical mesh implants.

The 510(k) process does not require pre-market clinical testing to establish the safety or efficacy of the device. Instead, the manufacturer has to show only that the product is “substantially similar” in safety and effectiveness to a product that is already on the market.

The proposed legislation would give the FDA the authority to require companies to collect data on a device’s performance and tighten its scrutiny of product recalls, the Times article said.

The letter sent by the three senators to Timothy M. Ring, the chairman and CEO of C.R. Bard, Inc., requested the company to disclose information by January 23 that includes:

        Outlining the systems and safeguards in place for monitoring devices, such as a device tracking system;
        How the company derived the device’s failure rates or rates of serious adverse events;
        How many individual complaints the company has received about its Avaulta pelvic repair mesh devices, how many were reported to the FDA, how many removal surgeries have been done to date (and how many surgeries are generally necessary to remove the mesh), and what percentage of the mesh is left in the body;
        How the company works with medical device registries, including the name and purpose of each registry, and how the company reconciles disparities in failure rates between registries; and
        Whether the company applies lessons from past recalls to present and future recalls, such as problems with communicating with patients in a recall.

Husbands of Medical Mesh Victims Finding Hope in New Website VaginalMeshHelpline.com

Posted by Shezad Malik MD JDDecember 05, 2011 1:08 AM
 

The Trans Vaginal Mesh (TVM) saga continues and another Multidistrict litigation is pending. American Medical Systems (AMS), a pelvic mesh manufacturer, is filing motions for the centralization and consolidation of all transvaginal mesh lawsuits filed in federal district courts throughout the United States.

There are currently at least 85 AMS mesh lawsuits filed on behalf of 133 different people, which are pending in 20 different federal district courts. The complaints all involve allegations of design defects associated with various AMS surgical mesh products, including the AMS Apogee, AMS BioArc, AMS Elvate, In-Fast Unltra, MiniArc, Monarc, AMS Perigee, SPARC and Straight-In mesh. The medical devices are implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

On November 23, AMS filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to consolidate all of the cases for pretrial proceedings in the U.S. District Court for the Eastern District of Minnesota. In the alternative, the medical device manufacturer has proposed that the cases be centralized in the Southern District of West Virginia.

AMS claims that centralizing the cases as part of an MDL, or multidistrict litigation, would serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulungs from different judges.

All of the lawsuits allege that problems with the design, manufacturing, testing, marketing or labeling of the AMS vaginal mesh products caused plaintiffs to experience severe complications and permanent injuries.

In July, the FDA issued a warning about the risk of transvaginal mesh problems, especially when used for repair of pelvic organ prolapse. A number of women have filed adverse event reports with the FDA after experiencing infection and erosion of the mesh through the vagina.

From January 1, 2008 through December 31, 2010, the FDA reports that it received 2,874 reports of complications linked to the use of surgical mesh devices meant to treat pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). A review of available data has led the FDA to conclude that there is no evidence that vaginal mesh implants provide any additional benefits when compared to more traditional surgeries to fix POP and SUI.

AMS argues that the cases should be centralized in Minnesota, where they maintain their headquarters and where most of the documents and witnesses are located.The first federal lawsuit involving AMS mesh was filed in September 2008 in the U.S. District Court for the Northern District of California, where 23 of the AMS cases are currently pending.

Only 4 lawsuits are pending in Minnesota, where AMS has proposed the litigation be centralized, and there are only 2 pending in the Southern District of West Virginia, which was identified as the alternative location.

Over the past year, a growing number of Bard Avaulta vaginal mesh lawsuits have also been filed by women who have experienced gynecological problems. All of the complaints involve similar allegations that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.

In October 2010, the federal Bard Avaulta litigation was consolidated as part of an MDL for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.

What is Vaginal Mesh?
Vaginal mesh, which is often called  a "hammock" or a "sling," is a device which is used after surgery to treat POP and stress urinary incontinence (SUI) in women. Many woman suffer these types of medical issues as a result of weakened pelvic muscles that stretch and weaken to the point where they can no longer completely support nearby organs.  As the pelvic floor muscles lose their retaining power, the bladder, urethra, bowel, and even uterus can "drop" downward, bulging into the vagina.  While there are several causes of this condition it normally occurs because of age, childbirth, hysterectomy, or menopause
While incontinence is not uncommon, normally when woman begin to experience symptoms like pressure, pain, SUI, constipation, and sexual problems, woman seek the advice of a doctor.  In another example of corporations putting profits over people, several medical device manufacturers began selling vaginal mesh as a cure all for these types of issues and told doctors and the world that these devices were safe for use.  Because of this sales job done by these medical device manufactures, vaginal mesh repair became very common as one of several surgical options.
The concept of the surgery is simple.  The doctor uses a surgical mesh to help reinforce the vaginal wall and provide an additional supporting layer to organs like the bladder or urethra which should ease the pain and permit woman to go to the bathroom easier.  However, it became apparent after several years after this product was used, many women began to experience complications like pain, lower back pain, pain up one leg or on one side of the body,bladder and bowel problems, infection, bleeding, extrusion, and urinary problems, pain during sexual intercourse and erosion of the mesh into the vaginal wall, bladder or bowel. The pelvic floor in a woman is an intricate network of muscle and ligaments that wrap secure, hold in place and protect the Uterus, Bladder and Bowel. Weakness and damage to this area can effect the entire structure of this system and the associated organs.

The FDA's Investigation into Transvaginal Mesh
          In 2006, a type of vaginal mesh called the "bladder sling", was removed from the market after studies found a high rate of vaginal extrusion where the sling started to rub against the  top of the vaginal wall the sling ripped through the wall causing major complications.
Then in October 2008, the FDA warned healthcare professionals about serious complications associated with vaginal mesh. By that time, the FDA had received over 1,000 reports about complications associated with other types of vaginal mesh.  Included in these complications were:

    •    Mesh erosion through vaginal wall or other body parts
    •    Infection
    •    Pain
    •    Urinary problems
    •    Recurrence of prolapse and/or incontinence
    •    Bladder, bowel or vessel perforation
    •    Vaginal scarring
    •    Pain during sexual intercourse
    •    Other problems that led to a significant decrease in patient quality of life due 
to discomfort and pain.            Now, after receiving over 3000 complaints from women who suffered serious injuries caused by polypropylene transvaginal device/mesh, the FDA issued a very detailed and comprehensive statement to warn doctors that they should consider no longer using mesh to treat their patients.  The reason for the warning was that, in most instances, the risk of serious injury outweighed all benefits from the transvaginal mesh.  In short, the FDA found that use of transvaginal mesh should only be used a matter of last resort.  
Recent Research Indicates Serious Risks and Complications
       In a recent article in the Journal of Obstetrics and Gynecology, the journal found that patients would have been better off with traditional treatment rather than being implanted with a vaginal mesh. A recent clinical study which has shown that more than 15 percent of women who had surgery which used vaginal mesh are experiencing dangerous and painful condition known as "erosion," in which the skin splits and the mesh protrudes.  The results of this mesh being exposed to your internal organs can be catastrophic.  If you feel any pain or suffer any symptoms or just don't feel right, you need to go to a doctor right away so the doctor can determine whether your problems are a result of vaginal mesh.
Four Transvaginal Device Manufacturers are Implicated in this problem
The manufacturers of the mesh and the products are as follows:
Johnson & Johnson®
    •    Ethicon® TVT
    •    Gynecare® TVT
    •    Gynecare® Prosima
    •    Gynecare® Prolift
    •    Gynemesh® PS

Boston Scientific®
    •    Advantage™ Sling System
    •    Obtryx® Curved Single
    •    Obtryx® Mesh Sling
    •    Prefyx Mid U™ Mesh Sling System
    •    Prefyx PPS™ System
    •    Arise®
    •    Pinnacle®
    •    Lynx®
    •    Solyx®

C.R. Bard®
    •    Avaulta Plus™ BioSynthetic Support
    •    Avaulta Solo™ Synthetic Support
    •    Faslata® Allograft
    •    Pelvicol® Tissue
    •    PelviSoft® Biomesh
    •    Pelvitex™ Polypropylene Mesh

American Medical Systems®
    •    SPARC®
    •    BioArc®
    •    MiniArc®
    •    Elevate®
    •    Monarc®
    •    Perigree®
    •    In-Fast®
    •    Apogee®

What to do?
            The most important thing to do if you are suffering from these symptoms is to go see a doctor.  The potential result from this mesh could be nothing more than an irritation, but it can be as severe as death. Mesh complications are dangerous. Infections can cause dangerous condiyions in your body, The first step is contacting the original Doctor that put the mesh in. Do not be alarmed if his reaction is Odd or insenstive. You may need to Pursue other avenues to get your medical needs met. Look for a urogynecologist with experience in mesh removal. Many University teaching hosptals have departments of urogynecology or pelvic or womens health centers. This is a good place to start. You will find some information on your state page of the vaginalmeshhelpline.com.  So you have to take care of your body. You cannot be afraid to see a doctor. Seek  a local Urogynecologist. Once you have had medical attention obtain all your records regarding the mesh and keep a  daily log of your complications. This will help if you choose to consult with an attorney. There are currently many lawyers filing Product liabilty actions against the manufacturers listed above.Seek an attorney with extensive experience in massive torts and drugs, orthopedic devices and medical implants. Make sure the lawyer you choose is keeping your case and going to trial on your behalf Many lawyers tke complex cases they do not have the experience to handle themselves and refer it to another firm. This firm can be anyplace in the United States. make sure the lawyer you hire is keeping the case "in house". Do not file choose a lawyer who will be filing your case as part of a class action or modified class. Find a lawyer who is taking cases on a individual basis only. Make sure you will be getting the personalized attention you need for your specific medical complications. Beware of solicitations and emails from would be lawyers.  These may be lead generation companies "selling you" to lawyers. Many states do not allow direct solicitation by lawyers. It is illegal. Avoid direct phone calls from lawyers or would be lawyers coercing information out of you. Again, these may be lead procurement centers, not law firms.  For assistance Call the helpline or email us today.

Physician Groups Address Transvaginal Mesh Complications

The American College of Obstetricians and Gynecologists and the American Urogynecologic Society have come out with strong recommendations against the use of Transvaginal Mesh for the majority of women.

In a joint Committee decision issued Tuesday, the groups said that due to concerns about the safety and efficacy of synthetic mesh placed vaginally for the treatment of pelvic organ prolapse (POP), its use should be reserved for high-risk women for whom the benefit may justify the risk.

The groups also say there is an urgent need for the development of a national registry to track outcomes for all current and future patients who receive vaginal mesh implants.

The uterus, bladder, urethra, small intestine, rectum, and top of the vagina are held in place by the pelvic floor muscles and connective tissues. “When these muscles become torn or stretched, pelvic organs can drop down and bulge into the vagina causing pelvic organ prolapse,” Cheryl B. Iglesia, MD, former chair of The College’s Committee on Gynecologic Practice, told health canal.com.

The two groups recommended that doctors continued to audit and review of outcomes as well as the development of a surveillance registry for all current and future vaginal mesh implants. They also advise surgeon training for vaginal mesh placement specific to each device, including surgical experience with reconstructive surgery and thorough understanding of pelvic anatomy; and rigorous comparative effectiveness trials of synthetic mesh and native tissue repair and long-term follow-up

 The Vaginal Mesh  receives emails and phone calls from women nationwide regarding horrors of their vaginal mesh experiences. The stories are of pain and suffering, lives ruined and marriages destroyed. They go to doctors who send them away and tell them they are imagining things. The doctors are generally insensitive and women are having trouble getting the mesh device removed.  The vaginal mesh helpline Is available for women to get Legal help ans well as medical help.

Vaginal Mesh Lawyer: The Friend the Woman Needs

Vaginal Mesh is a dangerous product. In fact, there is talk of recalling it. That is not to say that it is still not being used. It is. Vaginal Mesh is a material that is used in surgeries in which a woman is having dropped organs repaired.

Many times after child birth and with age, organs such as the bladder drop. The Vaginal Mesh is inserted into the tissues of the woman's vaginal to help strengthen the wall of the vagina. The product has been in existence since 2002. For many woman, they were not informed of the adverse reactions which might result due to the surgery. This has brought thousands upon thousands of cases into the courtroom as woman suffer from pain, bleeding, infections, thickening of the wall of the vaginal and cutting, and so on. There are many adverse reactions that the woman experiences due to the surgery and unfortunately often they last a lifetime. Vaginal Mesh repair surgery is an option, however, it too has adverse consequences and often the woman is left in a helpless position.
 

Obviously, for woman that have suffered, a Vaginal Mesh Lawyer is the advocate they need to receive compensation for their pain and suffering and for their altered lifestyle.
What to look for in a vaginal mesh lawyer

First and foremost, the lawyer should specialize in such cases. Years of experience in the field is crucial. The Vaginal Mesh Lawyer should have knowledge in dangerous drugs and medical products.

This month, experts in gynecology and obstetrics will meet to discuss the risks that are associated with the placement of vaginal mesh. At this time, they will discuss the clinical studies which may be necessary to conduct to determine the risks of vaginal mesh, and they will also discus the FDA's future recommendation.

The adverse affects of vaginal mesh is out. Unfortunately for many women, they were totally unaware of the dangers which may result. Today, women are still not being fully informed and make the wrong decision every day.

For women that have suffered, there is support. The Vaginal Mesh Lawyer is just the first step to recovery. When the woman life has been interrupted and they are living with pain, often on a daily basis, it is important that the woman have the support she needs emotionally, financially, and legally. It is the role of the Vaginal Mesh Lawyer to speak with the experts, put the woman's case together and make sure that she is awarded compensation for lost wages, medical bills, pain and suffering and an altered lifestyle. Because the placement of vaginal mesh often leads to a lifetime of pain, the lawyer will also look into the future, to ensure that all future medical costs and pain and suffering are also compensated for.

With each case that goes to court, woman are that much closer to having the product recalled, as continued use will become more and more costly for the manufacturers of the product and the doctors involved in the case.
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King Olive – About the Author:

If you're searching for a Vaginal Mesh Lawyer, make sure to familiarize yourself with the subject. This knowledge will help you to choose the best firm to represent your case.

With so many lawyers advertising on TV for women with Vaginal mesh comolications, email notices and direct solicitations it is hard to choose a vaginal mesh lawyer. it is important to understand that the Vaginal Mesh cases are being heard in Federal Court. With that in  mind the location of the lawyer is not as important as the skill and experience. many lawyers will take your case and refer it out to one the the Main lawyers who is doing the legal work. You are best with a lawyer who is hndling your case on and individual basis, not as a clas or modified class.  The complications are severe and must be treated  based on each case and the severity and quality of like injuries for you specific situation. Although there is no monetary reward that can compensate for the kind of pain and suffering we hear on a daily basis it is still important to take legal action. There are medical bills you will need to be reimbursed for. You have suffered and you must stand up and send a message and help other women. These mesh implant products are still on the market despite warnings and doctors are still using them. You must not allow this to continue. The legal venue is one way of sending a message. The vaginal mesh helpline listens to women on a daily basis and offers support, medical referral and connection to a lawyer. The lawyers affiliiiated with the helpline re taking cases on an individual basis.  The stories are horrific and you deserve compensation for your pain and suffering. According to KIng Olive  choosing the right lawyer can be your best decision. A Transvaginal Mesh lawyer with experience in dangerous medical devices can by your closest ally and confidant.

There is Hope, The Vaginal Mesh Helpline shares stories from women on their vaginal mesh complications. We found this blog on line and are sharing it with our readers.

Somehow we ladies, victims of mesh products have become members of a club we never wished to join.  Even though we don’t want to be part of it, we can turn the tables on the medical industry and help each other and those who cannot help themselves.

When I started this blog it was out of my own anger and frustration because I researched mesh before I had the surgery.  What I found was only older cases, pre 2008, and when I questioned this surgery, I was told that was the ‘old’ mesh and it had been recalled and everything was fine.  No more problems.  My doctor never once told me about a warning that the FDA had put out after a lawsuit in 2008 had been filed and settled by the women who had been scarred by bladder sling mesh.  She knows about my case because I have forced her to know and yet she continues to maim and injure new women with this product.  I am not the only member of her injured club either.  I know of at least one other woman who was maimed by her with this mesh and if women would speak up I am sure there are many more.

Yesterday I talked to a lady whom I have teamed up with to help all women who stumble in my blog and either leave a message on the blog or contact me directly.  She had her mesh removed by a great doctor in California in June of this year.  Like me she could not walk nor take on stairs.  I was thrilled when she told me yesterday that she now walks one step with one foot and the next with the other.  Sound odd?  It is because when you are crippled by mesh, you cling onto a banister and pulled yourself up one step, at a time, stopping to rest after each step to allow the pain to subside.  You avoid steps altogether whenever possible because you know with each step there will be a stab of pain in your thigh, leg and groin.  When she told me she could walk up stairs again I felt like a huge weight had been lifted.  I have been afraid I will be left damaged and in a wheelchair.  Now I have hope.  I do know this.  Getting the right doctor to remove all the mesh safely is the key.  Partial mesh removal will leave you as sick as you are now, or sicker.  Some doctors attempt to remove mesh then inform the patient it is impossible to remove the rest.  Not so!  The right doctor can reconstruct whatever has been torn up from previous surgeries and without the use of mesh products.  We have hope!

Another thing to know.  The FDA will be having a meeting on September 8th and 9th, with a panel to discuss the use of mesh.  In a moment I will give that information, in case you can attend.  For most of us it is impossible to do so.  However, we can stand up and be counted by the FDA.  Report your case!  I cannot say this enough because you may think the ads on TV means a recall.  It does not.  What it means is there has been enough cases reported to the FDA to prompt the July warning.  IT WAS NOT A RECALL.  That will only happen if everyone reports their cases and stands up and be counted.

To help you report your mesh complication I wrote a blog with all I learned when I reported mine.  It is effort to get the information you need, but don’t back out.  For every case reported, hundreds are not.  For every case unreported, more women will suffer with future mesh implants.  This is the information you need to report your case.  When I first wrote this, it had taken weeks for me to get the information.  Now I know better.  Go to the hospital you had your surgery and give them the date.  Ask to see the  PERIOPERATIVE NURSING NOTES.  Tell them all you need is the implant number and tell them where to find it.  You should not have to pay for this information.  Tell them you are having complications from the implant and the FDA wants the name and number.  Now here is what I wrote before.

How to report to the FDA  Where to find the manufacturer name  and lot number.
When I received my hospital medical records I immediately looked in the physicians Post Operative Report to find the product name and number.  I found the surgeon’s hand written note that it was Boston Scientific Advantage Fit Sling, so I went to the FDA site to report the product.  The FDA site is confusing because if you are not a medical technician, some things don’t make sense.  If you don’t give the right answer, the screen makes a noise and a box pops up.  I persevered and almost finished but was stuck because scanning through all the pages, I couldn’t spot it.  I fortunately had the email address of the woman who had her tape removed, who also happens to be an RN, so I sent Marianne an email last night asking for her help in this matter.
This morning she told me to look in the PERIOPERATIVE NURSING NOTES under implants.  Thank God for Marianne!  There it was, name, mfg and lot number.  I made my report to the FDA.
Why report it yourself?  My surgeon did not do it and if we, the victims don’t either, then more women will be injured.The moral of this story is GET THOSE NURSING NOTES WHEN YOU ORDER YOUR RECORDS.  Fortunately I did thinking there may be something important in them.  My lesson from all this is, order the hospital records first!  Report the product yourself, that way you know the government knows what is happening.  Doctors don’t care.  Then get this information to a lawyer!

About the upcoming FDA meeting.  I took this information from the FDA site.

Procedure:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before August 30, 2011.  Oral presentations from the public will be scheduled between approximately 10 a.m. and 11 a.m. on September 8 and 9, 2011. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 22, 2011.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by August 23, 2011.

Contact Person: Shanika Craig, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1613, 301-796-6639, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area.  Please call the Information Line for up-to-date information on this meeting.  A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

still have that piece of mesh in my freezer… just in case I need evidence. But, seriously, the smell of that plastic was just terrible when I opened the pot after the mesh was removed. Jane's interview with me gives a good overview of what happened – and I only had to suffer for a short while and was lucky enough to have complete removal. The surgeon I had was excellent and I am now fully functional and pain free – and says that after a couple of months it makes little difference how long the tape has been in as it is embedded fully and takes as much cutting out as if in years.

It is helpful to understand about how mesh deteriorates inside the body – look this research up and you will see magnification of different mesh and how they deteriorate -'Polypropylene as a reinforcement in pelvic surgery is not inert: comparative analysis of 100 explants'. It's horrific. So is this one, using rats and mesh to illustrate the negative effects of mesh:'Early tissue reactions in the rat bladder wall after contact with three different synthetic mesh materials'. It's bad enough for those rats, let alone us human guinea pigs. Mesh Medical newsdesk has a really interesting medical article that explains how mesh is being inserted into 'clean contaminated' parts of our body i.e. the vagina, which should never happen.

Fed up – what your 'successful' friends and relations do not know is the long term outcome of their TVT. It can sometimes be years before ill-effects become apparent and then they are serious. Obviously I would not wish that upon them, but you are in a position to know the risks you could be taking. Many women on this forum and others did not have problems initially. The advice given about staging your surgery, and trying pelvic physio is good: I'm now doing pelvic exercises having been TAUGHT and it's working well. I doubt I'll be completely dry all the time – but who cares. It's irrelevant compared to that dark place with mesh. Liz