UPDATE 01/04/2012: FDA Update on Surgical Mesh

    Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

The FDA continues to assess the safety and effectiveness of urogynecologic surgical mesh devices, through:

    Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study reports.
    Epidemiological research on safety and effectiveness of surgical mesh, as a part of our effort to better understand possible adverse events associated with surgical mesh for SUI and POP.
    Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events.
    Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices.
    Mandating postmarket surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices. On January 03, 2012, the FDA issued:
    88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and
    11 postmarket study orders to seven manufacturers of single-incision mini-slings for SUI.

The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices. For information on the status of the 522 Postmarket Surveillance Studies and the FDA’s authority to order 522 studies, visit the 522 website.

The FDA will provide additional information to the public as it becomes available.

The Vaginal Mesh Helpline hears from women on a daily basis regarding their complications. Based on what we hear the FDA is moving to slow. There are obvious complication with these surgical mesh implants and they are destroying the lives of 1000's of women nationwide.  We encourage wome to seek legal counsel regarding a modified district liltgation for their vaginal mesh and bladder sling implants immediately.

Having Prolapse, Cystocele and Rectocele Fixed Without Hysterectomy, Vaginal mesh, Bladder Sling

Frederick R. Jelovsek MD

"Is a hysterectomy absolutely necessary in order to repair a rectocele? Is there some procedure for repair without having to also have a total hysterectomy? This is after menopause, age 52, difficult birth of a child 24 years ago, now the herniated rectum (rectocele) is protruding through the vagina … not all the time…more after being tired at the end of a day." G.T.

"I am 50 yrs old and have been diagnosed with a prolapsed uterus, bladder, and rectum. From what I have read, this will be an increasing problem for the baby boom generation, as we age. The only treatment my doctor recommends is hysterectomy with rectal and bladder repair, which can fail and lead to other problems. Is any research being done into more effective ways to correct this problem? Are uterine resuspensions, using materials other than the patient's own tendons, a good option for older women?

I started periods at 12 and still having regular periods. I'm not taking any prescription drugs on regular basis. I have fibrocystic breast disease and my doctor does not want to prescribe estrogen. I do eat soy products. I feel the general public should be more aware of this condition and its causes, such as heavy lifting when you're older (my problem!!), certain delivery techniques, family history,etc ". Z6

Pelvic relaxation with its attendant possible loss of bladder support, rectal support, and support of the uterus and the vagina, is definitely a problem on the rise with an aging population. In post menopausal women, the rich blood supply of the vagina and surrounding tissues becomes less with age and the physical organ support those blood vessels play become less and less with time. This allows previous weakness in the support structure to worsen and allows pelvic organs to drop further until they come outside the vaginal opening or come close to the opening and just put stretch and pain on the remaining ligament attachments.

The condition of pelvic organ prolapse has had many different surgical approaches depending upon the surgeon's conceptual model of what the actual anatomical hernia defect is. It now appears that there can be multiple different defects in the supporting tendons (fascia) of the pelvis and even though the primary defects may be repaired at a given surgery, other secondary defects weaken with time resulting in the need for further surgical repair. The mesh of tendinous attachments of the vagina and uterus are like a nylon stocking that is attached to the sidewalls of the pelvis and the tailbone (sacrum). The "hosiery" comes in sheer, medium and support thickness just as women differ in their genetic makeup and tendon strengths. With childbirth, the "hosiery" mesh gets "runs" in it in one or more places. At first the runs are not big enough to cause loss of support. As more and more straining takes place on those "runs", some of them widen and lengthen and allow the organs that lie on the outside of the stocking, such as the bladder, rectum or uterus at the end, to fall down and collapse the stocking shut and eventually to turn it inside out. Surgeons need to know where the "runs" are in order to fix the defects.

Let us look at some of the factors at work in this still-to-be-better-defined condition of pelvic relaxation.

Why do doctors often recommend hysterectomy as part of the repair for prolapse?

I think it is true that most doctors will include hysterectomy (if all childbearing desire is done) in their recommendations for pelvic prolapse surgery. Scientific studies have not adequately addressed whether removing the uterus makes prolapse surgery any more or less successful than when the uterus is left except in the case of genuine stress incontinence. When genuine stress incontinence is present, loss of urine with coughing or sneezing, the support defect is called urethrocoele or loss of the urethrovesical angle. Studies have shown that correction of stress incontinence alone is neither more nor less successful if hysterectomy is performed (1).

The bottom line is that hysterectomy DOES NOT need to be performed when fixing pelvic support defects. With support defects such as bladder dropping (cystocoele), rectal wall protrusion into and out of the vagina (rectocoele), cul-de-sac hernia (enterocoele), and uterine prolapse, there have not been any large surgical series reported in which the uterus was left in place. Some of the smaller studies (2) reported for fixing uterine prolapse without hysterectomy seem to imply there is not a difference in the recurrence rate. So why do doctors almost always suggest hysterectomy? Here are some of my opinions:

    Many women request hysterectomy at the time of major prolapse surgery. Premenopausal women request it because they feel that the absence of menses will be more convenient or, if they are having pain, abnormal bleeding or Pap smear problems, that those conditions will go away. Postmenopausal women request hysterectomy because removing the uterus with its cervix and the ovaries will almost totally abolish the chance of ovarian, uterine and cervical cancer.
    Doctors find that patients have more difficulty with hormone replacement therapy (HRT) because they must take progestins along with estrogen so they do not develop endometrial cancer. The progestins and even natural progesterone tends to produce more mood side effects and bleeding side effects. These side effects of HRT entirely go away if a woman has a hysterectomy because the source of the bleeding (uterus) is gone and there is no need for progestin or progesterone and their side effects since the endometrium has been removed and does not need to be protected from cancerous changes.
    In their training, many physicians did not learn or commonly practice surgical techniques in which the uterus was left in. Thus they are "more comfortable" in their surgical experience with removing the uterus at the time of prolapse surgery. Almost always with cystocele or rectocele, there is also some degree of vaginal vault prolapse and the procedures to suspend the vagina so it does not prolapse in the future are almost as extensive as the hysterectomy as far as surgical and anesthesia time, as well as the risks of surgical complications or injury.
    There is a common unsubstantiated conception among many patients and some physicians that the weight of the uterus will put more downward pressure on the pelvic support structures and worsen prolapse in the long run, thus making their surgery less likely to be successful.
    Post operative recovery time from pelvic hernia surgery is about the same whether or not the uterus is removed. It is about 6 weeks before a woman should return to work unless she has a very sedentary job, and for another 6 weeks there should be very little intraabdominal straining in order not to disrupt the prolapse repairs.

Keep in mind there are many physicians who are comfortable correcting prolapse defects surgically without removing the uterus. One organization of surgical specialists in prolapse surgery is the Society of Gynecologic Surgeons. They have a geographic list of physicians.

How effective is surgery at fixing these prolapse problems?

Almost all prolapse surgery has some failures. Successes of most of the procedures range from 65%-90% although the longer the patients are followed, the lower the permanent success rate. The biggest reason for recurrence of prolapse problems is that all of the anatomical defects present were not recognized or not evident at the time of the original surgery. Every gynecologic surgeon has had experiences in which patients return 1-5 years or more later with symptomatic prolapse of one of the sites not originally thought to be a problem. Sometimes when one anatomic area is fixed, all of the excess intraabdominal pressure from lifting, straining or chronic coughing is redirected to a weaker area. This weaker area over time develops a hernia.

Women who undergo surgery for prolapse should take at least 3 months off from any lifting over 10 pounds and any intraabdominal straining as much as possible. In my opinion they should never engage a strenuous occupation or regular leisure activities that demand increased intraabdominal pressure. Many of the surgical failures that I am aware of had episodes of moving furniture, a sudden fall with moderate impact or some other episode of abdominal straining during which they felt a "pop" and then subsequent pelvic pressure.

What are some of the complications of prolapse surgery?

The major complication is failure of the procedure to keep the pelvic organs supported. Other complications are those of any major surgery such as wound infection, blood clot to the lung, anesthetic complications, lung or bladder infections, or injuries to adjacent organs such as the rectum, bowel, bladder urethra (tube from the bladder to the outside) or ureter (tube from the kidney to the bladder).

Another complication more unique to prolapse and hernia surgery is infection in the area of non human materials used during the surgery. Synthetic mesh, bone tacks, and even non dissolving sutures that are used during the surgery can become infected (about 3-5%) and produce chronically draining pus sinuses. Surgeons like to use the natural tissues and ligaments to repair these hernias if possible but sometimes the tissues are just too weak and a synthetic material is needed.

Long term residual pain in the areas of scarring along surgical suture lines is a rare but major complication of this surgery. In the case of rectocoele repair the pain can be with intercourse or with having bowel movements or even with walking (3) and sometimes fecal incontinence can occur. In the case of cystocoele or bladder repair, pain can also be with intercourse, voiding of urine or a chronic pubic bone pain.

Are there new techniques and materials being tested to improve the surgical success of this problem?

There are always new publications about different procedures, methods and materials to help improve the success of prolapse surgery. For stress incontinence, "bone tacks" are being tried. Synthetic mesh made of Prolene®, Mersilene® and Gore-Tex® have been used for support of the vagina or cervico- vaginal area to repair uterine or vaginal prolapse (4)

What are the key considerations when faced with a decision for possible surgery for prolapse.
(Note — The following suggestions about surgical procedures may seem highly technical, but the only way to avoid a high likelihood of recurrent prolapse is to have the most appropriate surgical repairs done in the first place.)

A primary consideration with pelvic organ prolapse is whether or not you have associated urinary incontinence with straining or coughing. If you do not have incontinence at present, do you get incontinence if you wear one or two large tampons in the vagina to elevate the bladder and uterus? Also, during your pelvic exam by the doctor, you should expect a "Q-tip" test. This is an exam in which the doctor puts a small cotton-tipped applicator lubricated with xylocaine gel into the urethra. Then you are asked to strain down. If the applicator rises 30 degrees or more, this means that the urethra-bladder neck drops down with straining and it is very likely that if you do not already have stress urinary incontinence, you will develop it after the surgery if the doctor does not plan to include some type of bladder neck suspension as part of your surgical procedure.

Another consideration is for the doctor to carefully examine any bladder dropping (cystocoele) and determine whether or not the anatomical defect is in the middle of the vaginal wall under the bladder or whether it is at the sides of the vagina (paravaginal). Doctors previously only performed a procedure called anterior colporraphy as if all cystocoeles were midline defects. Now we know that most defects are paravaginal. Therefore the surgeon's plan for correction of a cystocoele should almost always include a paravaginal repair done from a vaginal, abdominal or laparoscopic approach. If not, at least the doctor should be able to explain why a specific procedure is being planned for.

Finally, if any uterine or vaginal prolapse is present, ask the doctor what tissues the vagina will be reattached to to prevent it from falling down again. Usually the answer will include either the uterosacral ligaments, the sacrum or the sacrospinous ligament. If the doctor suggests you should not worry about the precise method of suspension or just suggests a vaginal hysterectomy with an anterior cystocoele and posterior rectocoele repair, it might be prudent to get a second opinion. That does not mean these procedures are not effective, but they can be a marker for a surgeon who is not following the recent literature closely.

Many of our senior and elder women are having complications with a vaginal mesh. At the helpline we hear form women 33 to 87.

They are all suffering however the older a woman gets the more serious infection is and the risk of  turning septic becomes a very real threat. Post menapause women have a weakened vaginal wall and can be more easily prone the incontinence and bladder prolapse. The mesh implants were place in women of all ages including women over the age of 70 and even 80. Complications and bleeding at that age can be life threatening. If you have a mesh and are having complications you must see a physician immediately.

The Vaginal mesh helpline and the Vaginal mesh female social worker help women locate a urogynecologist and vaginal mesh lawyer. Call 888 522-2123 today.

The vaginal mesh lawsuits are mult district litigations, not class actions. A multi district litigation consolidates all women with particular complications from a mesh of a particular manufacturer in one federal courthouse under one judge. This can be any place in the United States.

You are not alone. We speak to 100's of women a week. Most of them feel their doctors are insensitive and are not up to date on the complications. It has been difficult for women to find a doctor who understands that your complications are very real.

Complication of a failed mesh include

• Increased urinary incontinence
• Bowel and bladder problems
• Severe pain described like a knif or razor blade
• infection
• piercing of bladder or bowel
• abdominal pain
• lower back pain
• spot bleeding
• pain during sexual intercourse
• pain on one side of the body
• need for catherization to vacate completely
• re-prolapse
• erosion thru the vaginal wall (partner can feel it or is being cut by it )
• marriages destroyed
• Failure of the Procedure
• Pain (Vagina, leg, pelvic, adbominal)
• Infection or rejection of the graft material

• Recurrent urinary tract infection
• Extrusion of the mesh into the vagina causing pain, discharge, bleeding
• Erosion of the mesh into bowel, bladder, urethra, or rectum

• loss of employment. Inability to work
• inability to enjoy a quality of life
• depression and emotional distress

You are not alone. Call 1 888 522 2123 now  If you are in:

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‘Burdensome Provisions’

‘Devise Lineage’

McCain-Casey Bill

To contact the reporter on this story: Alex Nussbaum in New York at

Transvaginal Mesh Bladder Perforation is a complication of the vaginal mesh. Bladder perforation can be fatal. You must be aware of this and be on guard for any symptoms.

Transvaginal mesh bladder perforation is a serious complication associated with the use of transvaginal mesh patches, surgically implanted devices that are intended to:

•     relieve bladder pressure
•     strengthen damaged vaginal walls
•     support the organs of the lower abdomen.

When mesh patches become displaced, they can puncture the bladder once or multiple times. In the most serious cases, the neck of the bladder is perforated, and emergency medical treatment will be crucial to saving an affected patient's life. We cannot impress upon you enough the need for medical followup for all symptoms and complications. These are serious side effects that can lead to surgery and even death.
Symptoms of Transvaginal Mesh Bladder Perforation Are Serious

Although symptoms of transvaginal mesh bladder perforation will vary depending on the location and severity of the bladder trauma, most women affected by transvaginal mesh bladder perforation will experience some combination of the following:

•     abdominal inflammation
•     bloating
•     blood in urine (hematuria)
•     difficulty or inability to urinate
•     pain and/or tenderness in the lower abdomen
•     painful urination

In the most serious cases of bladder perforation, patients will also likely experience:

•     decreased blood pressure
•     drowsiness, disorientation and/or confusion
•     increased heart rate
•     paling, cooler skin
•     sweating                                                                                                                                                                    Transvaginal mesh patch users who develop any of the above symptoms should seek immediate medical attention to prevent further, potentially fatal complications.                                                                                                             Diagnosing Bladder Perforation

To definitively diagnose bladder perforation, doctors will ask patients about any abdominal surgeries and/or injuries they have endured – including whether an affected patient has a history of using a transvaginal mesh patch. Subsequently, medical professionals will:

•     physically examine the abdominal region (a process that typically includes feeling the lower abdomen and assessing patient's pain and level of inflammation)
•     test patients' urine for blood or other indications of bladder perforation
•     test patients' blood to evaluate whether urine has spilled out of the bladder
•     perform CT scans and/or MRIs to assess the number and type of bladder perforations

Most affected patients will need surgery, catheterization and pain medication to treat their bladder perforation(s). About 20 percent of all cases of bladder trauma are fatal.
Following Bladder Perforation Treatment

After patients have followed through with all prescribed treatments for their bladder perforation, they should set up a free consultation with a personal injury attorney who specializes in transvaginal mesh lawsuits. For help and support contact the Vaginal Mesh Helpline

Women affected by any of the above transvaginal mesh injuries should:

•     Seek emergency medical attention to prevent further complications, including death.
•     Follow through with all long-term treatments.
•     Meet with a transvaginal mesh lawyer to learn more about their legal rights.

Brands of Harmful Mesh Patches

While injurious mesh patches are marketed and distributed under dozens of different names, some of the more notable varieties include:

•     ObTape®, produced by the California-based Mentor Corporation. ObTape assumes the function of damaged urethra muscles by sitting at the top of the urethra to control urination and prevent urine leaks.
•     SPARC®, produced by the Minnesota-based American Medical Systems. SPARC treats stress incontinence by supporting the urethra and preventing urine leaks when pressure is placed on the abdomen (due to exercise, laughing, lifting, etc.).
•     T-Sling®, produced by the California-based Caldera Corporation. T-Sling minimizes strain on the urethra by absorbing stress on the abdomen as it sits under the urethra.

We are here to help you. Vaginal Mesh Helpline

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