At the Vaginal Mesh Helpline we have been contacted by many women whose vaginal mesh case has been rejected by a law firm for many different reasons. Many are inexperienced local lawyers while  others have been rejected for a variety of other reasons. The key factors appear to be lack of confirmation from a physician that the mesh is casuing a problem and that either revision surgery or removeal is needed. Well ladies ,you know when you have symptoms. However, many doctors are not willing to say that the mesh is causing a problem or women do not have funds to go to a doctor. Call the vaginal mesh helpline to be connected to a law fim  and get a second opinion. Do not give up hope . You must seek justice.

FDA Adverse reporting Guidelines
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available:

Documenting this type of information will be extremely helpful when you contact a lawyer as well. The FDA guidlines are an excellent record keeping formate to follow.

•     Manufacturer's name
•     Product name (brand name)
•     Catalog number
•     Lot number
•     Size
•                               Your Lawyer Will Want to Know
•     Date of implant
•     Date of explant (if mesh was removed)  (Important)
•     Details of the adverse event and medical and/or surgical interventions ( Important )
•  
•     Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
•     Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
•     Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
•     Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment

Vaginal mesh failure symptoms

Complications of the Vaginal Mesh include:

• Failure of the Procedure
• Pain (Vagina, leg, pelvic, adbominal)
• rejection of the graft material
• chronic continuous relentless infections
• the need for constant antibiotics
• patch bleeding
• lower back pain
• pain on one side of the body
• painful sexual intercourse
• partner feeling the mesh
• constant bleeding or spotting
• 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

For medical Support

Contact a local University Hospital Dept of Urogynecology

or the American Association of Urogynecology

or see the states and resource pages on vaginalmeshhelpline.com

The Vaginal Mesh Helpline is keeping women updated on all drugs and medical devices effecting women.Womens health lawyers division is watching all implants, drugs and medical devices that harm women. FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.We are posting this announcement to keep women informed of the risks. If you are effected by this warning andhave had these complications please contsac our helpline to be connected to a lawyer. We are horrified at the number of drugs and medical devices that are harming women. Vaginal Mesh, Mirena IUD, Yaz, Yasmine and others are harming women nationwide. We must seek justice.

On April 10, 2012, the U.S. Food and Drug Administration (FDA) announced a label change for drospirenone-containing birth control pills, such as Yaz and Yasmin, to include the increased risk for developing dangerous blood clots.

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11:  Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.

Safety Announcement

[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin.  Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.  See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots.  For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.

The revised drug labels (Beyaz, Safyral, Yasmin ,Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.

Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; for women who use birth control pills; for pregnant women; and for women in the postpartum period.  For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.

Figure 1: Likelihood of Developing a Blood Clot

Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; who use birth control pills; and for women in the postpartum period
COC = combination oral contraceptives or birth control pills

These studies were discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.

Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011.  The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins.  Previously published studies had reported conflicting findings.  The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives.  The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

Today's communication is in keeping with FDA's commitment to inform the public about the Agency's ongoing safety review of drugs.  FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.

Table 1. Approved Oral Contraceptives Containing Drospirenone

• 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 0.03 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
• 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
• Yaz
• Drospirenone 3 mg and ethinyl estradiol 0.02 mg
• Zarah
• Drospirenone 3 mg and ethinyl estradiol 0.03 mg

    Updated External Questions and Answers – Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots

    4-10-2012

    Beyaz Label

    4-10-2012

    Safyral Label

    Yasmin Label

    4-10-2012

    Yaz Label

    FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone

    9-26-2011

    FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone

    10-27-2011

    FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

    5-31-2011

    FDA Briefing Information for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 1.86MB) (PDF – 5.2MB)

    FDA Drug Safety Podcast for Healthcare Professionals: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

Vaginal Mesh Helpline Announces new helpline for women harmed by these birth contol pills.

 

 

 

Legislators are seeking to regulate the approval process for vaginal mesh and similar medical devices.

A Massachusetts lawmaker has introduced a new bill which would allow for stricter regulation of the medical device approval process. The bill specifically  targets    Vaginel mesh Device which have become the target of numerous lawsuits filed on behalf of women who say these products caused serious health complications.

At a press conference Thursday morning, Rep. Ed Markey (D-Mass.) introduced the new bill, called the Safety of Untested and New Devices (SOUND) Act. The new legislation would allow the U.S. Food and Drug Administration (FDA) to require manufacturers of medical devices based on existing products that have known safety issues to provide documentation showing that the new product’s design has eliminated potential flaws.

Representative Markey introduced the new bill in the hopes that it would be incorporated into a larger bill that Congress is set to vote on at the end of May. The larger bill, while aimed at increasing FDA oversight of the medical device approval process, does not contain specific wording that would currently close an existing loophole, known as the 510(k) rule. Under the 510(k) guidelines, a medical device  manufacturer may seek approval of a device without conducting additional safety testing if it can prove that the device is substantially similar to a product that is already on the market, regardless of whether the existing product has any known safety issues.

Thus far, the bill has yet to gain any Republican support. While the FDA has acknowledged the need for a Congressional measure to help close the existing 510(k) loophole, the agency has not issued any official statement lending to support to the larger bill already before Congress or the new SOUND Act. Earlier this month, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, spoke out against the loophole, saying it challenges the credibility of the medical device approval process.

The FDA approves an average of 28 devices per year using the 510(k) guidelines. Statistically, a new device is five times as likely to be recalled if its design is based on an older device that has known safety issues. This is the case for the Johnson & Johnson Ethicon Gynecare vaginal mesh system, which was based on an existing mesh product manufactured by Boston Scientific. That product, the ProtoGen mesh system, was recalled shortly after the Ethicon mesh gained approval. Now, the Ethicon Gynecare system, along with vaginal mesh devices manufactured by Boston Scientific, American Medical Systems and C.R. Bard are the subject of numerous lawsuits filed on behalf of women who say these devices caused severe pain, swelling, tissue damage, blood vessel damage, bladder and bowel perforation and other complications. The vaginal mesh helpline hears from women on a daily basis regarding their vaginal mesh complications. Women are suffering, lives have been dramatically altered. Someting must be done. Doctors are still implanting these mesh devices even after the 2008 warning. The stories are horrific and our callers seek justice.

The Vaginal Mesh Helpline receives calls from women on a daily basis regarding their vaginal mesh complications. many have urinary tract infections which is one of the reported side effects of a vaginal Mesh implant. Below is an overview of urinary tract Infections

 Most urinary tract infections are not serious and can be easily treated with antibiotic medications. However urinary tract infections from a Vaginal mesh implant can become chronic. The symptoms of a urinary tract infection can be stubborn  with a vaginal mesh and can persist after treatment. Many reported  Infections are recurring and come back just a  few weeks after treatment. Nearly 20 percent of women who have a urinary tract infection will have another, and 30 percent of those who have had two will have a third. About 80 percent of those who have had three will have a fourth. If left untreated, urinary tract infections can lead to other more complicated health problems so they should not be ignored.

How the Urinary Tract Works

Your urinary tract includes two kidneys, two ureters, the bladder and the urethra. Your kidneys remove waste and water from your blood to produce urine. Urine travels through muscular tubes, called the ureters, to the bladder. The bladder is a balloon-like organ composed of muscle, connective tissue and nerves that swells as it fills with urine. Urine is stored in the bladder until it is released from the body through another tube, called the urethra. Two muscle groups, the pelvic floor muscles and the urinary sphincters, control the activity of the urethra and bladder neck. These muscles must work together to hold urine in the bladder most of the time and allow the bladder to empty when appropriate.

Cause of Urinary Tract Infection: Bacteria, Potentially from Mesh Erosion and Scar tissue

Most urinary tract infections are caused by a variety of bacteria, including Escherichia coli (E. coli), found in feces. Because the openings of the bowel, vagina and urethra are very close together, it's easy for the bacteria to spread to the urethra and travel up the urinary tract into the bladder and sometimes up to the kidneys.

Untreated Urinary Tract Infections: Bladder & Kidney Infections—Important

Infection occurs when the bacteria cling to the opening of the urethra and multiply, producing an infection of the urethra, called urethritis. The bacteria often spread up to the bladder, causing a bladder infection, called cystitis. Untreated, the infection can continue spreading up the urinary tract, causing infection in the kidneys, called pyelonephritis. Pyelonephritis can also occur without a preceding bladder infection. A kidney infection that is not treated can result in the bacteria entering the bloodstream (this is known as urosepsis), which can be a life-threatening infection requiring hospitalization and intravenous antibiotics.

The first sign of a bladder infection may be a strong urge to urinate or a painful burning sensation when you urinate. You may feel the urge to go frequently, with little urine eliminated each time. The urge to urinate again returns quickly, and urination may be hard to control. You may have urinary leakage. You may also have soreness in your lower abdomen, in your back or in the sides of your body. Your urine may look cloudy or have a reddish tinge from blood. It may smell foul or strong. You also may feel tired, shaky and washed out. If the infection has spread to the kidneys, you may have fever, chills, nausea, vomiting and back pain, in addition to the frequent urge to urinate and painful urination.

Common Causes of UTIs, However UtIs have been reported side effects form vaginal mesh implants

Some women are more prone to urinary tract infections than others because the cells in their vaginal areas and in their urethras are more easily invaded by bacteria. Women with mothers or sisters who have recurring urinary tract infections also tend to be more susceptible. Your risk of urinary tract infection also is greater if you're past menopause. Thinning of the tissues of the vagina, bladder and urethra, as well as change in the vaginal environment after menopause, may make these areas less resistant to bacteria and cause more frequent urinary tract infections.

Irritation or injury to the vagina or urethra caused by sexual intercourse, douching, tampons or feminine deodorants can give bacteria a chance to invade. Using a diaphragm can cause irritation and can interfere with the bladder's ability to empty, giving bacteria a place to grow.

Any abnormality of the urinary tract that blocks the flow of urine, such as a kidney stone or significant prolapse of the uterus or vagina, also can lead to an infection or recurrent infections. Illnesses that affect the immune system, such as diabetes, AIDS and chronic kidney diseases, increase the risk of urinary tract infections. A weak bladder can also make it difficult to empty completely, allowing bacteria to grow. Lengthy use of an indwelling catheter, a soft tube inserted through the urethra into the bladder to drain urine, is a common source of urinary tract infections. Intermittent catheterization (where a person empties the bladder several times a day but the catheter is removed immediately) actually is used to prevent recurrent infections in some patients.

Because the uterus sits directly on the bladder during pregnancy and can block the drainage of urine from the bladder, UTIs are more common in pregnant women. And when women develop urinary tract infections during pregnancy, the bacteria are more likely to affect the kidneys. Hormonal changes and repositioning of the urinary tract during pregnancy may make it easier for bacteria to invade the kidneys. Such infections in pregnant women can lead to urosepsis, kidney damage, high blood pressure and premature delivery of the baby. All pregnant women should have their urine tested periodically during pregnancy. Pregnant women with a history of frequent urinary tract infections should have their urine tested often. Most antibiotic medications are safe to take during pregnancy, but your health care professional will consider the drug's effectiveness, how far your pregnancy has progressed and the potential side effects on the fetus when determining which medication is right for you and how long you should take it. If you have a vaginal mesh and are showing signs of chronic infection we advise you to see a Urogynecologist immedicately. Vaginal mesh helpline Lawyers are accepting clients with transvaginal  mesh complications.

Vaginal Mesh Helpline Announces the Bard and Johnson and Johnson Vaginal mesh Multi District litigation has been consolidated in New Jersey. Vaginal Mesh Helpline Lawyers are filing lawsuits in new Jersey for women injured by the Bard and J&J vaginal mesh implants.

C.R. Bard products lawsuits  consolidated in New Jersey

    Bard Pelvitex
    Bard Pelvisoft
    Bard Pelvilace or Pelvicol
    Bard Utrtex
    Bard Uretex TO
    Bard Uretex TOO2
    Bard Uretex TOO3

Gynecare / Ethicon / Johnson & Johnson products

    Gynecare Prosima
    Gynecare TVT Exact
    Gynecare TVT Abbrevo
    Gynecare TVT Retropubic System
    Gynecare TVT
    Gynecare TVT Obturator
    Gynecare TVT Secur
    Gynecare Gynemesh PS
    Gynecare Prolift
    Gynecare Prolift+M

Three multidistrict litigations involving the risks of transvaginal mesh were consolidated this past week into a single MDL before Chief Judge Joseph R. Goodwin the U.S. District Court for the Southern District of West Virginia. The MDLs were filed against Boston Scientific, American Medical Systems and Johnson & Johnson’s Ethicon Inc.

Judge Goodwin was already handling another MDL involving Avaulta transvaginal mesh against C.R. Bard. Consolidating so many similar MDLs before one judge is very unusual. However it will benefit our clients to have a streamlined process overseen by the same judge, regardless of which company manufactured their defective TVM implant.

The Vaginal Mesh Helpline hears from women on a daily basis regarding their mesh  complications

• Vaginal Pains and Bleeding
• Vaginal infections
• patch bleeding
• painful intercourse
• lower back pain
• trouble voiding or urinary incontinence
• Vaginal extrusion of the surgical mesh, and
•  bladder and bowel erosion

The Boston Scientific Vaginal Mesh Lawsuits have been Consolidated in Massachusetts.

The vaginal mesh lawsuits are multi District litigations. That means that the lawsuits against one manufacturer are consolidated in one courtroom in the country. The Boston Scientific Mesh has been consolidated in Massachusetts. The Vaginal Mesh Helpline Lawyers will be filing suit for women injured by the Boston Scientific Mesh in Massachusetts.

Boston Scientific Transvaginal Mesh and Sling Products Include:

• Pinnacle Pelvic Floor Repair Kits: Used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
• Uphold Vaginal Support system: Used to treat pelvic organ prolapse (POP).
• Advantage Fit Sling System: Used to treat stress urinary incontinence (SUI).
• Obtryx Sling System: Used to treat stress urinary incontinence (SUI).
• Prefyx Sling System: Used to treat stress urinary incontinence (SUI).
• Solyx SIS System: Used to treat stress urinary incontinence (SUI).
• Lynx Sling System: Used to treat stress urinary incontinence (SUI).

Complications reported to the Vaginal Mesh Helpline Include:

• Mesh erosion through the vaginal wall bladder or bowel
• Mesh extrusion and exposure
• Perforation or puncture of bladder, intestines, bowels, and/or vaginal wall
• Protusion or lump in the vaginal opening
• Chronic Infection
• patch bleeding
• pain on one side of the body
• difficulty in passing urine or urinary incontinence
• feeling of discomfort and muscle tightening
• Recurrence of Pelvic Organ Prolapse (POP)
• Recurrence of Stress Urinary Incontinence (SUI)
• lower back pain
• Vaginal bleeding
• Painful sexual intercourse 

Women who experience Boston Scientific transvaginal mesh complications  have attempted to locate a doctor tp have their mesh removed . The vaginal mesh Helpline reports women having numerous surgeries to remove the mesh.

Boston Scientific Pinnacle Pelvic Floor Repair Kit Recall

In August 2011, Boston Scientific issued a Class 2 recall for about 540 Pinnacle Pelvic Floor Repair Kits. According to the recall notice, manufacturing problems had resulted in some products exhibiting a low tensile strength between the needle and suture. This could cause needle detachment during mesh leg placement.

If you are having complications from a Boston Scientific vaginal Mesh contact the vaginal Mesh Helpline today.

The Vaginal mesh helpline gets calls from women daily who are being told by their doctors nothing is wrong. The symptoms are usually similiar. They have severe pain and cannot function, Their incontinence is back worse or the cannot void, They have lower back pain, they cannot have sexual intercourse, they are having patch bleeding, and other types of bladder and bowel problems. While doctors are looking for tumors, lower back problems and medications to calm them down psychologically they call the Vaginal Mesh Helpline worried an upset.

What do they all have in common? Some kind of vaginal mesh product that is "ruining their lives". The mesh was usually put in by a gynecologist or urologist. The reason was anything from severe prolapse to simple SUI. Doctors believed the answer to every single female problem was the mesh. This was the new miracle cure.  Women went in for a hysterectomy and came out with a mesh. But, it just is not playing out that way. Mny women did not seem to even realize a mesh was being used until the turn on their T.V set and see the symptoms in the layer Ads.

Our vaginal mesh callers are feeling like  their lives are over. They are in pain, distraught, angry and losing their marriages, boyfiriends and fiances over this " Miracle Mesh".  Women are losing their jobs and cannit work. School bus drivers cannot drive a bus any longer due to the severe pain.

Many of these women were lead so astray by their doctors that hey are only first realizing their complications are the mesh when they see a lawyer ad on T.V.  "look , a family member says, this is you". "You need to look into this right away" 

They call the helpline.  Or maybe they just got an email blast from a leads company or lawyer.  The advertising for the mesh is waking women up to what is really going on inside their body.

Very few can go back to the doctor that put the mesh in. Doctors are to frightened right now to give good medical care. They are worried about the consequences of what they did.  Many are telling women that they are fine.  "It is all in your head"' There is nothing wrong here"

They attempt to cut of the "Bad Part". We had a women caller whose Doctor tried to pull the piece out.  What can a woman do ?

We suggest the call the association of Urogynecologists for a local Urogynecologist. We also suggest they locat a local University Hospital Department of  Urogynecology.  "You must ask for a Doctor who has experience in mesh removal". "That way you will know that they understand there is problems with the mesh".

What else can women do? They must get on the list for the Mult District litigation with a lawyer who has experience with mass torts.

They must be alerted to leads companies that are soliciting to sell them to lawyers.  It is not in your head. You are not alone and you must seek medical advise.  These mesh implants can cause very serious complications and hut the internal organs. Bowel Bladder and vaginal erosion is a potentail result. Mesh Erosion into the bowel or bladder can be very serious.

In 2011, the FDA published new guidelines regarding manufacturer requirements for pelvic mesh. Since the institution of such guidelines, Boston Scientific represents the first company to received FDA approval for a new pelvic mesh. We do not know ,nor do many of the women calling, what mesh they have. We do not know if this knew mesh is one of the ones creating problems in 2012. What we do knoe is an estimated 300,000 women have these mesh implants and are suffering.

Harris-Hicks, who practices at Sandhills Gynecology of Sandhills Regional Medical Center, has 12 years of experience in POP surgery. She received her training at Greenville Memorial Hospital in Greenville, S.C.

“POP and urinary incontinence are common conditions affecting many adult women today,” said Harris-Hicks. Pelvic organ prolapse is the abnormal descent or herniation of the pelvic organs including the bladder or rectum from their normal position inside the pelvis. Severe POP results in complete extrusion of the vagina outside of the pelvic floor.

Read more: Richmond County Daily Journal – Sandhills Gynecology physician among top surgeons to use new product for leaky bladders
 

Vaginal Mesh Lawsuit Claims Company Wasn’t Honest
Elise Kramer | March 13th, 2012 | Posted in Vaginal Mesh Helpline

Vaginal mesh Helpline brings new news on vaginal mesh lawsuits. Vaginal mesh lawyers Filing lawsuits Nationwide. New Vaginal mesh lawsuit against American Medical Systems.

A new vaginal mesh lawsuit filed on the 24th of February, 2012, accuses device manufacturer American Medical Systems, Inc. of not being entirely honest about their vaginal mesh products by underreporting the side effects associated with such devices. The lawsuit was filed in the United States District Court for the Central District of California by plaintiff Robin McAlpine and her vaginal mesh lawyer. The plaintiff says that the company aggressively marketed the Monarc Subfascial Hammoc vaginal mesh system to patients, making them believe that it was the best option to treat urinary incontinence and pelvic organ prolapse when, she claims, it is a defective device.
Vaginal mesh plaintiffs detail side effects

Pelvic organ prolapse is a condition that manifests most commonly in women who have had children or are going through menopause. The pelvic floor is weakened, causing pelvic organs to shift or drop. Transvaginal mesh systems can help support these organs if they are implanted in a patient who is suffering from pelvic organ prolapse.

According to her lawsuit, plaintiff McAlpine received the Monarc Subfascial Hammock vaginal mesh device manufactured by American Medical Systems on the 5th of October, 2005. She began to experience vaginal mesh complications immediately afterwards. These complications included erosion, infection, fistula, inflammation, scar tissue, and organ perforation. She had the mesh removed in October of 2010, after which she had revision surgery and vaginal reconstruction. In addition, she claims to continue to have pain related to the vaginal mesh complications she suffered.

She claims that American Medical Systems exaggerated the effectiveness of the transvaginal mesh system so that patients would choose their product over other modes of treatment for urinary incontinence or pelvic organ prolapse. She also claims that the design of the device was defective and that AMS withheld information from consumers regarding the safety of the vaginal mesh device.
High vaginal mesh failure rate outlined

Plaintiff McAlpine’s lawsuit outlines the high rate of vaginal mesh failure that has been noted in more than 15 percent of women who have had vaginal mesh implants. She claims that the company not only failed to warn the public of the possibility of failure but also conducted inadequate clinical tests. She is asking for both compensatory and punitive damages.
 

Cystocele Mesh Repair  has lead to Complications, Vaginal mesh helpline Offers Support and Guidance

What is a Cystocele ?

Cystocele is the name of a disorder in women in which the muscles and tissues between the bladder and the vagina stretch and weaken, causing the bladder to drop or prolapse into the vagina. hernia in which the urinary bladder protrudes through the wall of the vagina; sometimes occurs after childbirth. Cystocele is often called “fallen bladder.” Other names include cystocele prolapse and cystocele bladder prolapse.

A bladder that has dropped from its normal position may cause two kinds of problems-unwanted urine leakage and incomplete emptying of the bladder. In some women, a fallen bladder stretches the opening into the urethra, causing urine leakage when the woman coughs, sneezes, laughs, or moves in any way that puts pressure on the bladder.

A cystocele is mild-grade 1-when the bladder droops only a short way into the vagina. With a more severe-grade 2-cystocele, the bladder sinks far enough to reach the opening of the vagina. The most advanced-grade 3-cystocele occurs when the bladder bulges out through the opening of the vagina.

Repair of Bladder Prolapse (Cystocele) or Urethra Prolapse (urethrocele)

Two common forms of pelvic organ prolapse are bladder prolapse (cystocele) and urethral prolapse (urethrocele). A cystocele occurs when the wall of the bladder presses against and moves the wall of the vagina. A urethrocele occurs when the tissues surrounding the urethra sag downward into the vagina. Both conditions are easy for your doctor to see during a physical exam. They often occur at the same time and are usually caused by damage that happens when a baby is delivered through the mother's birth canal (vagina)

What causes a Cystocele ?

Most common causes
Pregnancy and vaginal childbirth are the most common causes of a cystocele. Women who have only cesarean section deliveries are less likely to develop prolapse.

Other causes
Prolapse may also be caused by straining your pelvic floor muscles through:

• Being overweight or obese
• Repeated heavy lifting
• Straining with bowel movements
• A chronic cough or bronchitis

Symptoms that Result.

Once the bladder has dropped from its normal position, it can cause symptoms like urine leakage, incomplete emptying of the bladder, and stress urinary incontinence (SUI—urine leakage that occurs when a woman coughs, sneezes, or laughs). The severity of the symptoms depends on the severity of the cystocele:

    Grade 1 (mild): the bladder drops only a short way into the vagina
    Grade 2 (moderate): the bladder reaches the opening of the vagina
    Grade 3(severe): the bladder bulges through the opening of the vagina

Treatment for Cystocele Prolapse

Treatment for cystocele depends on the severity of the condition. Women with mild cystocele may be able to manage it simply by avoiding heavy lifting and straining. If symptoms are moderately bothersome, a doctor may recommend a pessary, which is a removable device placed in the vagina to help keep the bladder in place. Estrogen therapy may also help strengthen the muscles around the bladder.

For severe cases of cystocele, surgery may be required to move the bladder back into a normal position and keep it there. Traditional surgeries simply stitched the muscles and connective tissues together to hold the bladder, but this surgery was prone to relapse. Cystocele mesh repair seemed like a better option, until women started experiencing serious complications.
Cystocele Mesh Repair May Cause Complications

In cystocele mesh repair, a surgeon uses a synthetic surgical netting to help support and secure the bladder back in place, and to lend strength to surrounding muscles and tissues. Studies have shown that this repair typically lasts longer, as far as keeping the bladder in place, but unfortunately, it can cause more complications, which may include:

•     Pelvic pain
•     Infections
•     erosion into the bladder or bowel
•     Bleeding
•     Incontinence
•     bowel incontinence
•     Mesh extrusion
•     Painful intercourse
•     Cystocele bladder prolapse recurrence
•     Vaginal scarring and mesh erosion

FDA Warning About Cystocele Mesh Repair

In addition to the July 2011 FDA warning about the risks of complications with vaginal mesh repair, the agency also scheduled a subcommittee meeting to further evaluate the safety issues. The mesh was pushed thru on the FDA fast track wothout additional testing. The consensus from that meeting was that the safety of vaginal mesh is not well established, and more clinical studies need to be done on the currently available products.
Call the Vaginal mesh helpline to speak to a female medical social worker and a cystocele mesh lawyer.