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GranuFlo Lawyers, NaturaLyte Lawsuits

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Fresenius Medical is the manufacturer of GranuFlo and NaturaLyte acid concentrate. These are drugs used in dialysis treatment. There has been a recall of these dialysis drugs and lawsuits are being filed.

Injury and death has resulted from these drugs:

  • GranuFlo cardiovascular death,
  • GranuFlo sudden cardiac death,
  • GranuFlo cardiopulmonary arrest,
  • GranuFlo heart attack,
  • GranuFlo catastrophic cardiovascular injuries

Fresenius manufactures GranuFlo and NaturaLyte used in dialysis. These drugs cause alkalosis, a condition associated with an increase in cardiovascular fatalities.

The FDA received complaints describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.

This can contribute to metabolic alkalosis, which is a significant risk factor associated with :

Low blood pressure

Cardiopulmonary arrest

Cardiac arrhythmia

Sudden heart attack

Stroke

Hemodialysis cardiopulmonary arrest

A study which was conducted between January and December of 2010 found that patients with pre-dialysis bicarbonate levels greater than 28mEq/L were 4.7 times more likely to suffer a cardiac arrest. The study also discovered that patients with pre-dialysis potassium lower than 4 mEq/L had a 6.3 times higher risk of cardiac arrest.

In May 2012 the FDA notified health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ dialysate prescription.

There is a GranuFlo and NaturaLyte Class 1 Recall

Serial numbers for recalled Naturalyte Liquid Acid Concentrate range from:

08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-

Serial numbers for recalled Naturalyte GranuFlo (powder) Acid Concentrate range from:

OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B

GranuFlo & NaturaLyte is one of the most widely prescribed dry acid products used for dialysis at Fresenius clinics, as well as other hemodialysis centers that purchase their dialysis supplies from Fresenius. It is estimated that 125,000 patients in non-Fresenius clinics are treated with GranuFlo.

Dilaysis Patient Alert

If you, a loved one or someone you care for has been injured by these products contact us for a GranuFlo and NaturaLyte lawsuit.

Bladder Sling Lawyers, Vaginal Mesh Lawsuits

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The bladder mesh is a vaginal mesh product primarily used for urinary incontinence. This mesh sling has caused severe complications and bladder mesh lawyers are filing lawsuits. Many women with a bladder mesh do not realize they are eligible to file a vaginal mesh lawsuit.

What is a Bladder Sling?

Urethral sling or bladder sling is used to treat urinary incontinence by placing a sling around the urethra to lift it back into a normal position and to exert pressure on the urethra to aid urine retention. The sling is attached to the abdominal wall. A bladder sling is a mesh device and is part of the vaginal mesh litigation. The complications of a failed bladder sling is increased incontinence or trouble voiding. Many women have needed to self catherize.

Bladder Sling Complications?

According to the July 2011 FDA news release, the most common complications associated with surgical mesh bladder slings is erosion thru the vaginal wall or into the bladder, pain during sexual intercourse, bleeding, infection, perforation of various pelvic organs (bladder, colon, vaginal walls), and urinary incontinence or problems voiding as well as; neuromuscular problems, emotional problems, mesh contraction/shrinkage, and even a reoccurrence of POP and/or SUI.

Bladder sling lawsuits are being filed on a contingency fee basis against the mnaufacturers of the bladder sling:

Bard Avaulta Support System
AMS Elevate Prolapse Repair System
AMS Apogee Vault Suspension System
AMS Perigee System
AMS Monarc Sling System
AMS Sparc Sling System
Ethicon Gynecare Gynemesh
Ethicon Gynecare Prolene Soft Mesh
Ethicon Gynecare Prolift Pelvic Floor Repair System
Ethicon Gynecare TVT Transvaginal Sling
Boston Scientific Pinnacle Pelvic Floor Repair Kit
Boston Scientific Uphold Vaginal Support System
UGYTEX Dual Knit Mesh
Coviden IVS Tunneler Sling

Contact us today.

Stryker Hip Replacement Lawyers, Stryker Hip Replacement Helpline

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Adding to the Zimmer and DePuy metal on metal hip replacement Stryker has recalled it s latest metal component hip replacement implant. Stryker has voluntarily recalled the Rejuvenate metal component hip replacement implant and ABG II modular- neck stems
Stryker has voluntarily stopped market distribution of these hip replacements due to increased risk of injury. The hip replacement implants have been shown to fret or corrode, harming body tissue and causing pain and swelling. Other injuries include:

  • Severe inflammatory reactions
  • Pain in the groin
  • metal toxicity ort poisoning
  • high metal levels in the blood
  • need for additional surgery
  • Breakdown of muscles, tendons and other soft tissues in and around the hip joint
  • Loss of surrounding bone
  • Loss of mobility

While other types of hip implants such as those made by Johnson & Johnson and DePuy Orthopaedics Inc. involve a metal ball rubbing against a metal socket, the Stryker Rejuvenate products involve a metal neck inside a metal stem. The Stryker Hip replacement Helpline and hip replacement lawyers are reaching out to all victims of the failed device for a potential multi district litigation.

The products have metal components and although they are not metal on metal run the same risks of chromium and cobalt toxicity poisoning. If you have been injured you are advised to contact your doctor immediately and contact the Stryker Hip Replacement Helpline for a Stryker lawyer

Pradaxa Breaking News, Pradaxa lawyers, Pradaxa Lawsuits, Pradaxa Bleeding

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Pradaxa has warnings for excessive bleeding. Pradaxa Helpline is concerned about Pradaxa and the elderly

The Pradaxa Helpline Has Pradaxa Lawyers to Help You

LONDON | Fri May 25, 2012 6:07am EDT

(Reuters) Doctors and patients should be given clearer guidance on how to avoid bleeding risks when using Boehringer Ingelheim s new stroke prevention pill Pradaxa, European regulators said on Friday.

The European Medicines Agency said data continued to confirm the positive benefit-risk balance of the anticoagulant medicine, despite cases of fatal bleeding, but advice on the risks should be strengthened.

Pradaxa is the first in a new class of medicines aimed at replacing the old and problematic drug warfarin. It is designed for use after hip and knee surgery and to prevent strokes in patients with atrial fibrillation, a form of irregular heartbeat common among the elderly.

Rival drugs include Xarelto, from Bayer and Johnson & Johnson, and Eliquis, from Bristol-Myers Squibb and Pfizer.

Pradaxa is an anticoagulant. Anticoagulants effect the clotting time of the blood. Pradaxa is described as a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. Pradaxa lowers the chance of blood clots forming in your body. There is a chnce of excessive bleeding on Pradaxa that can be fatal.

We can locate a Pradaxa lawyer to help you:

Silicone Breast Implant Claims Lawyers, Silicone Breast Implant Class Action

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Breast implant Class Action lawyers Helping women with Dow Corning, Mentor and other Silicone breast implant claims.

Silicone breast implants caused silicone toxicity and Immune deficiency diseases with symptoms of:

  • Muscle Pain -Upper arms, neck, chest, upper back, thighs, buttocks
  • Joint Pain -hands, feet, toes, elbows
  • Pressure headaches
  • Ringing in ears
  • Sun sensitivity & rash; face, neck & upper chest
  • Hives
  • Intermittent tingling in legs, feet, arms, fingers, right upper back, neck and face
  • Many urinary tract and yeast infections
  • Burning lips, mouth, tongue
  • Dry eyes, nose, mouth, and vagina
  • Nausea, heartburn, constipation, diarrhea
  • Insomnia
  • Anxiety

And:

  • Breast Pain
  • Upper and Lower Back Pain
  • dry eyes
  • joint pain and swelling
  • myalgias
  • chronic fatigue
  • Lupus
  • numbness and tingling in extremities
  • photosensitivity
  • Chemical Sensitivities
  • Muscle Pain, Stiffness, Unusual Fatigue
  • Excessive Hair Loss
  • Achy or Swollen Joints
  • Extreme fatigue
  • Skin Rashes
  • Rheumatoid Arthritis
  • Polymyositis-Dermatomyositis
  • Mixed Connective Tissue Disease
  • Scleroderma
  • Sjogren s syndrome
  • Anemia
  • Sensitivity to Sunlight
  • Kidney Problems
  • Fever
  • Difficulty Swallowing or Breathing

Women are still suffering today and settlements are still pending for the Silicone Breast Implant Clas Action. If you currently are registered fo r one of the breast implant settlement manufacturers and need help with your claim call 1 877 522-2123

Women Filing nationwide Vaginal mesh lawsuits, vaginal Mesh lawyers

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The vaginal mesh has been wrecking havoc on womens lives and the numbers are just starting to reveal themselves. Wome have stories about their vaginal mesh and are ready to file vaginal mesh lawsuits. one of the women below:

Texarkana woman files personal injury lawsuit over vaginal mesh implant
5/21/2012 10:22 PM By Michelle Keahey, East Texas Bureau

TEXARKANA After suffering several complications allegedly stemming from transvaginal mesh implantation, a Texarkana woman has filed a personal injury lawsuit against the medical device manufacturer.

Peggy Green filed suit against Boston Scientific Corp., doing business as Mansfield Scientific Inc. & Microvasive Inc. on May 14 in the Eastern District of Texas, Texarkana Division.

Due to stress urinary incontinence, Green was surgically implanted with the Uphold Vaginal Support System, manufactured by the defendant, on May 14, 2010.

After her surgery, she began to experience complications such as vaginal pressure and pain, vaginal bleeding and/or dyspareunia. She states that these complications are the result of the implanted medical device.

The defendant is accused of breach of warranty, negligence, and failure to warn.

The plaintiff is seeking an award of compensatory damages, punitive damages, exemplary damages, incidental damages, consequential damages, attorney s fees, and court costs.

Green is represented by Erin K. Copeland of Fibich, Hampton, Leebron, Briggs & Josephson in Houston. A jury trial is requested.

U.S. District Judge Michael H. Schneider is assigned to the case.

This is just one of many vaginal mesh lawsuits. If you have been injured and your life destroyed by a defective vaginal mesh do not delay. There are statue of limitation issues. contact our vaginal mesh free legal department today.

Bayer Settles on Yaz, Opens Door to Yaz Lawsuits

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The Yaz Helpline and Yaz Lawyers are pleased to announce Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous Yaz blood clots

In addition to the Yaz settlements the Food and Drug Administration has placed new warnings on Yaz packaging du to numerus studies showing a link between Yaz and blood clots, stroke and pulminery embolism. This new warning comes as a reiied to medical practitioners who are prescribing Yaz. and have been concerned about the impact of Yaz side effects. Thousands of women affected by Yaz side effects including Yaz deep vein thrombosis and Yaz gallbladder disease have filed suit against drug maker Bayer. In light of the new warnings and settlement offers Yaz lawyers are accepting cases for yaz.

Yaz Hotline is here to help women harmed by yaz. Call and Speak to a female Social Worker and be connected to a yaz lawyer

Women s Yaz Hotline Launch is based on a recently issued FDA Warning for the drugs YAZ,Yasmin and Ocella.MDL lawsuits for Yaz,Yasmin are currently being filed. If you have experienced complications with Yaz,Yasmin or ocella,call the a Yaz, Ocella,Yasmin Lawyer Hotline Attorney today. The hotline is here for you 24/71 877 522 2123 You will speak to a medical social worker.
The Federal/State Yaz, Yasmin, Birth Control Lawsuits are being filed by Yaz Lawyers. The Yaz, Yasmine Hotline is here to answer your questions and connect you with a YAZ, Yasmin or Ocella lawyer.Referencing the New York Times," Yaz has been one of the top-selling birth control pills in the U.S and Canada., with nearly 20 percent of the market. In 2008, more than $600 million dollars worth of Yaz was sold in the U.S. However, the television commercials advertising Yaz were of concern to the FDA and the Attorney General because they implied that Yaz could be used to treat or cure symptoms for which it was not FDA-approved, such as:

  • Keeping a woman s mild acne at bay
  • Relieving symptoms of PMS (premenstrual syndrome):
  • irritability
  • increased appetite
  • moodiness
  • fatigue
  • headaches
  • bloating
  • muscle aches

Bayer agreed to make new commercials and print advertisements that did not promise more for Yaz than had been approved by the FDA, and that did not minimize the risks of Yaz birth control pills, which are many. Yaz is FDA-approved only for:
preventing pregnancy
treating the symptoms of PMDD (premenstrual dysphoric disorder) in women who are using Yaz as their contraceptive
treating moderate acne vulgaris in women who are using Yaz to prevent pregnancy
Safety Announcement
[09-26-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA s Drug Safety Communication issued on May 31, 2011. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study (See Data Summary), FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.

Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.
Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. FDA previously communicated preliminary information about these concerns to the public on May 31, 2011 .
FDA has prepared a list of questions and answers to provide an overview of this potential safety issue. FDA will continue to communicate any new information to the public as it becomes available
Health Canada is currently reviewing the safety of Bayer Pharmaceutical’s birth control pills, Yaz and Yasmin, in an effort to determine if women who use these drugs are at an increased risk of developing life-threatening blood clots over women using different brands of birth control.

Yaz Lawyers of Free Legal Shield are pleased to announce that contraceptive Manufacturer, Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous blood clots.

New Warning Labels on Yaz April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots.

Many Studies show Yaz linked to Blood Clots

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.

Yaz New Warnings April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots

Yaz side effects include:
• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Blood clots
• Stroke
• Heart attack
• Gallbladder problems
• Pancreatitis
List of Drugs
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

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

  • Yasmin®
  • Yaz®
  • Ocella®

Injuries reported:

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Stroke
  • Heart Attack
  • Wrongful Death
  • Blood Clot Related Injuries
  • Kidney Failure
  • Gallbladder Injury/Removal

If you or a loved one has suffered from any of the harmful side effects of Yaz,Yasmin or Ocella such as blood clots, stroke or heart attack you may be entitled to file a Yaz,Yasmin,Ocella lawsuit against the manufacturer. Call us for a yaz lawyer with experience in birth control drug lawsuits toevaluate your claim. Many women around the United States have suffered from life-threatening Yaz,Ocella and Yasmin birth control side effects. The manufacturer can be held liable.
The Woman s Yaz Hotline is here for women suffering from Yasmin and Yaz and Drospirenone side effects

Cystocele and Rectocele Mesh Repair, FDA Warnings

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Risks with Cystocele and Rectocele Mesh Repair , FDA Warnings, Vaginal mesh lawyers

In July 2011, the FDA released a safety communication warning healthcare providers of the serious risks associated with surgical mesh used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Specifically, the FDA stated that complications were not rare, and that surgery with the mesh may be no better than traditional surgery options that don’t use mesh.

Public Citizen and Vaginal mesh

In October 25, 2011, a consumer advocacy group called Public Citizen submitted an appeal to the FDA that all non-absorbable vaginal mesh be recalled. They stressed that there is a need for these non-absorbable vaginal meshes to be removed from the market since it’s benefits over other non-mesh procedures used to repair POP and SUI were unseen, and patients who received them developed fatal reactions. The group also recommends that all non-absorbable vaginal mesh be tested appropriately for safety and effectiveness before the FDA approves its availability in the market.

FDA 510 (K) Process

Manufacturers needed only to show they were similar to devices already on the market to gain approval through the FDA’s 510(k) approval process. The remaining eight recalled devices didn’t have to go through any kind of FDA review. Of the 113 recalls, 35 were for cardiovascular devices, including automated external defibrillators, or AEDs, and only 12 of them had been required to undergo patient testing.

POP repair surgeries may include cystocele and rectocele. Unfortunately, complications have been found with both.
Types of POP Repair Include Cystocele and Rectocele.The sling procedure, or suburethral sling procedure, refers to a particular kind of surgery using ancillary material to aid in closure of the urethral sphincter function of the bladder. It is performed as a treatment of severe urinary incontinence. The sling procedure, also known as the suburethral fascial sling or the pubovaginal sling, has many forms due to advances in the types of material used for the sling. Some popular types of sling material are Teflon (polytetrafluoroethylene), Gore-Tex ® , and rectus fascia (fibrous tissue of the rectum).

Cystocele and rectocele repair

  • Cystocele—bladder prolapse
  • Rectocele—rectal prolapse (end of the large intestine, or rectum)
  • Uterine prolapse
  • Vaginal prolapse
  • Enterocele—herniated small bowel

Mesh was initially incorporated into POP surgical repair because it offered more support to the affected organ and helped shore up surrounding muscles and tissues. Since the risk for recurrence of prolapse is high in women who have cystocele surgery and rectocele surgery, the hope was that surgical mesh would help sustain the repair. The FDA received many reports, however, or cystocele mesh complications and rectocele mesh complications.

Mesh complications

  • erosion of mesh
  • serious infection
  • recurrence of pop / sui
  • perforation
  • pain
  • corrective surgeries
  • injury to other organs
  • vaginal scarring
  • urinary problems
  • hardening of mesh

Cystocele Mesh Complications and Rectocele Mesh Complications

During cystocele surgery, transvaginal mesh is inserted through the vagina to help act as a barrier and to hold the bladder in place. The mesh is also intended to help stop related problems like incontinence.

A rectocele occurs when the thin wall of tissue separating the rectum from the vagina weakens, allowing the front of the rectum to bulge into the vagina. During rectocele surgery, excess stretched tissue is removed through the vagina, and a mesh patch may be used to support and strengthen the wall. (Surgery may also proceed from the abdomen, anus, or perineum.)

Though surgical mesh does seem to provide better support for pelvic organs, cystocele mesh complications and rectocele mesh complications made the improvement a moot point. The FDA, in its 2011 warning, mentioned that it had received nearly 3,000 reports of vaginal mesh complications between 2008 and 2010, with the most common being mesh erosion through the vagina. Mesh erosion can require multiple surgeries to repair and may be extremely debilitating.

Other cystocele mesh complications and rectocele mesh complications included pain, infection, bleeding, pain during sex, organ perforation, urinary problems, recurrent prolapse, vaginal scarring/shrinkage, and neuro-muscular problems. Many required additional surgical treatment and hospitalization.
Cystocele Surgery and Rectocele Surgery

Cystocele, urethrocele, enterocele, and rectocele are particularly likely to occur together. Urethrocele is virtually always accompanied by cystocele (cystourethrocele). Cystocele and cystourethrocele commonly develop when the pubocervical vesical fascia is weakened. Enterocele usually occurs after a hysterectomy. Weakness in the pubocervical fascia and rectovaginal fascia allows the apex of the vagina, which contains the peritoneum and small bowel, to descend. Rectocele results from disruption of the levator ani muscles.

Severity of these disorders can be graded based on level of protrusion:

  • 1st degree: To the upper vagina
  • 2nd degree: To the introitus
  • 3rd degree: External to the introitus

If you have been injured due to a vaginal mesh from any of the manufactuirers listed below contact Vaginal mesh Helpline 1 877 522-2123

Manufacturers

Johnson & Johnson

  • Ethicon TVT
  • Gynecare Prolift
  • Gynecare Prosima
  • Gynecare TVT
  • Gynemesh PS

C.R. Bard

  • Avaulta PlusT BioSynthetic Support
  • Avaulta SoloT Synthetic Support
  • Faslata Allograft
  • PelvitexT Polypropylene Mesh
  • Pelvicol Tissue
  • PelviSoft Biomesh

Boston Scientific

  • AdvantageT Sling System
  • Prefyx Mid UT Mesh Sling System
  • Prefyx PPST System
  • Obtryx Curved Single
  • ObtryxMesh Sling
  • Arise
  • Pinnacle
  • Solyx
  • Lynx

American Medical Systems

  • SPARC
  • BioArc
  • MiniArc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • Perigree

vaginalmeshhelpline.com

Vaginal Mesh a Disaster for Women, Lawyers filing lawsuits

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If you have a vaginal mesh and are experiencing complications you need to find a Urogynecologist and you must get a Vaginal mesh lawyer.

Ask Questions and Get Answers. You are not alone and you are not imagining it. Over 300,000 women have vaginal mesh implants. They are failing in women across the country and lawsuits are being filed. Ask Qustions and get answers. These are not class Action litigations. They are multi district litigations. That means they are consolidated in certain states in certain courtrooms under one judge and that may not be the state you are in. You need an experienced mass tort lawyer who will be appearing in court for you as a part of this multi district litigation. These are not class actions. You will have your case filed on an individual basis as an MDL. Ask quesions and get answers. You do not need a local lawyer. You do need a lawyer that is keeping your case and not referring it out to another lawyer to go to court for him. Ask Questions and get answers. Choose your vaginal Mesh lawyer wisely.

What is the Vaginal Mesh?

Also known as a pelvic sling, bladder mesh, or transvaginal mesh, the vaginal mesh support systems are used to help with pelvic organ prolapse as well as urinary incontinence It is now known that they can cause serious internal injuries. These vaginal mesh patch implants, manufactured by Johnson & Johnson , C.R. Bard, Boston Scientific, American Medical Systems, and others, may cause pain, infection, erosion, organ damage, and additional surgeries, and other vaginal mesh injuries.

If you have experienced vaginal mesh complications following pelvic organ prolapse surgery or stress urinary incontinence surgery, The vaginal mesh support line will offer help and direct you to a lawyer who may be able to help you obtain significant compensation for the vaginal mesh problems you are experiencing.

Ask questions and get answers

Call us at 1 877 -522-2123 to speak with a female social worker and be directed to a lawyer.

Vaginal Mesh- History of the Problem

Between the years of 2005 and 2010, nearly 4,000 vaginal mesh injuries have been reported to the Food and Drug Administration. In a 2010 article in the journal Obstetrics & Gynecology, researchers stated that they had to cease a vaginal mesh clinical trial early because of the higher-than-expected number of complications and injuries. The trial was stopped when it was discovered that more than 15 percent of women who were implanted with vaginal mesh suffered vaginal mesh erosion within only three months of implantation. As a result of numerous negative reports, the FDA issued a vaginal mesh warning to patients and physicians in 2011, cautioning that the risks of using vaginal mesh are so severe that alternative treatments should be considered. It is now widely accepted that, in most cases, pelvic organ prolapsed can be treated without the use of vaginal mesh

What are the vaginal Mesh complications ?

  • Erosion of vaginal tissue
  • infection
  • spot bleeding
  • pain during sex
  • lower back pain
  • pain on one side
  • depression
  • Hardening of the vaginal mesh
  • Infection
  • Pain and discomfort
  • Perforations of the bowel, bladder or blood vessels
  • Recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
  • Urinary problems
  • Vaginal mesh erosion
  • Vaginal scarring

Many women who have suffered injuries as a result of vaginal mesh have decided to file defective medical device lawsuits. This has become a middle district litigation and are being filed as MDl s are being filed. A product liability, multi district litigation lawyer can review your case. Ask questions and get answers. call our Transvaginal mesh support line today.

Doctors Investigating Faulty Medical Devices Suing FDA

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FDA SUED BY ITS OWN DOCTORS AND SCIENTISTS

Whistleblowers accuse FDA of spying, persecution

03 February 2012

The US Food and Drug Administration (FDA) is being sued by its own scientists and doctors who allege they were spied on and persecuted by the agency for expressing safety concerns about the approval of medical devices. This legal action has prompted an investigation by a key lawmaker in the Senate.
It's claimed that the FDA installed spyware to monitor personal email accounts

Iowa Republican Senator Charles Grassley a powerful member of the judiciary committee that has jurisdiction over areas like civil liberties and constitutional law has asked FDA commissioner Margaret Hamburg to provide details about who authorised the monitoring of employees and why some of the plaintiffs are no longer employed by the agency. Hamburg has until 17 February to supply her answers.

In the lawsuit filed on 25 January, six whistleblowers claim that the FDA secretly spied on them for two years. They say that the agency began its campaign of electronic snooping after the agency learned that they had written a letter to the president elect, Barack Obama, and his transition team in early 2009 detailing misconduct in approving unsafe medical devices. In that letter, the plaintiffs called the FDA fundamentally broken , and said its scientific review process for medical devices has been corrupted and distorted by managers.
Soon after, the agency installed or activated spyware on the whistleblowers work computers and also monitored their private emails, according to court documents. In addition, evidence suggests that the FDA took screen shots of the employees computers and also intercepted their emails to and from staff members on key House and Senate oversight committees.
These actions appear to have continued even after the Office of Inspector General (OIG) at the FDA s parent agency the Department of Health and Human Services (HHS) denied the agency s request to take criminal or administrative action against the individuals. In a May 2010 letter to the FDA, the OIG concluded that the whistleblowers communications were legally protected.
Chilling effects
The plaintiffs, who were all heavily involved in the FDA s safety review process, are seeking an injunction to stop the agency from pursuing what they say is an illegal spying campaign. Two of these whistleblowers still work at FDA and say that they face continued harassment, two were fired and another two did not get their contracts renewed, according to Stephen Kohn, the lead attorney for the plaintiffs.
If you can target someone simply because they raise a legal, health or safety concern, that will have a chilling effect on any FDA employee alerting the public or Congress about matters of life and death, Kohn tells Chemistry World . There is a lot of pressure on these scientists to approve the devices.
According to Kohn, the whistleblowers raised major concerns about 20 medical devices that involve, among other things, ultrasound and CT scan technology. Specifically, these reviewers said some of the devices could expose patients to radiation at levels up to 800 times that of a chest x-ray and they found that others couldn t appropriately detect cancers. Nevertheless, Kohn says the FDA approved 19 out of 20 of these devices that had been flagged.
Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so, while also risking their professional careers, they are often treated like skunks at a picnic, Grassley wrote in a 31 January letter to Hamburg, asserting that retaliation against whistleblowers should never be tolerated .
Grassley said that certain employees, including members of the Public Health Service Commissioned Corps within HHS, are not covered under the US Whistleblower Protection Act, which leaves them vulnerable to retaliation. He says that this is a one of several loopholes in current law that should to be closed.
The FDA said it can t comment on personnel issues or any matters subject to ongoing litigation.
Rebecca Trager