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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Monthly Archives: August 2013

Vaginal mesh ineffective and dangerous, study shows

Posted in Vaginal Mesh

Transvaginal mesh (TVM) is a mesh implant used to treat damaged vaginal tissues.  One condition TVM has been commonly used to treat is called pelvic organ prolapse (POP).  POP is characterized by weakening of the tissues that hold the pelvic organs in place, and occurs in 30-50% of women. An observational study, titled “Total transvaginal… Continue Reading

Italian research team finds high rate of complications associated with TVM

Posted in Vaginal Mesh

Vaginal mesh in pelvic floor reconstruction has become more and more popular, and this is partially due to the high failure rates associated with older methods.  In an article titled “Rising Use of Synthetic Mesh in Transvaginal Pelvic Reconstructive Surgery:  A Review of the Risk of Vaginal Erosion”, written by the Department of Gynecology and… Continue Reading

Contemporary research highlights TVM dangers

Posted in Vaginal Mesh

In the United States alone, over 300,000 pelvic floor reconstructions and urinary incontinence are performed.  Around 29 percent of these surgeries are reoperations.  The high failure rate of older methods gave way to the development of vaginal mesh kits in 2005.  Mesh-augmented vaginal prolapse repairs have shown to improve anatomical outcomes and are associated with… Continue Reading

Research shows significant risks associated with vaginal mesh

Posted in Vaginal Mesh

There are many risks involved with re-operation after pelvic floor reconstruction.  Older methods used to treat organ prolapsed repair were associated with high rates of failure, hence newer, more safe methods such as the use of synthetic materials are being used to augment pelvic organ prolapse repair.  In a report titled “Review of  Synthetic Mesh-Related… Continue Reading

Vaginal mesh repair in POP often unsuccessful

Posted in Vaginal Mesh

In 2011, the International Urogynecological Association published a study called “Prospective Study of Anterior Transobturator Mesh Kit for the Management of Recurrent Anterior Vaginal Wall Prolapse”, where the objective was the assessment of the 2 year outcome of anterior Prolift for patients with recurrent anterior vaginal wall prolapse.  Anterior wall repair is a procedure that… Continue Reading

Study shows: Transvaginal mesh is unsafe

Posted in Vaginal Mesh

The objective of a study called “Outcomes and Predictors of Failure of Trocarguided Vaginal Mesh Surgery for Pelvic Organ Prolapse”, written by the department of Obstetrics and Gynecology, Reinier de Graaf Group, and the Department of Obstetrics and Gynecology at  Radboud University Nijmegen Medical Centre in Nijmegen, The Netherlands, was to compare the outcomes of… Continue Reading

“Synthetic Vaginal Mesh for Pelvic Organ Prolapse” Shows: Mesh is Dangerous

Posted in Vaginal Mesh

In 2004, the FDA cleared the use of synthetic vaginal mesh delivery systems.  The high failure rates from traditional vaginal colporrhaphy and apical suspension procedures using native tissue is what gave way for the development of the new mesh method.  Familiarity for surgeons with the transobturator region increased as a result of the deployment of… Continue Reading

Vaginal mesh found to cause complications or fail at high rate

Posted in Vaginal Mesh

Pelvic organ prolapse (POP) is a major health issue, especially concerning to older women.  Women who have had multiple children have a 50 percent chance they will one day need corrective surgery, and recurrence rates as high as 70 percent have been seen after traditional vaginal prolapse surgery.  This has caused many doctors to recommend… Continue Reading

TVM complications found to be frequent and dangerous

Posted in Vaginal Mesh

Over the past 20 years, the use of mesh for correction of sphincteric abnormalities has greatly increased.  High success rates and simpler surgical techniques have helped its overall appeal.  Recently, there has been mounting concern over potential complications with this new procedure.  4,000 reports of TVM complications were submitted to the FDA by 2010-average of… Continue Reading

High rate of POP recurrence associated with vaginal mesh

Posted in Vaginal Mesh

It is estimated that 300,000 pelvic organ prolapse related surgeries are performed in the United States every year.  Pelvic organ prolapse is a global wide health issue for women.  High failure rates are seen with anterior surgical repair of cystocele or anterior wall prolapse.  These procedures may constrict and impair vaginal anatomy.  Some doctors recommend… Continue Reading

Connection between cerebral hemorrhage in newborns and maternal AED use found

Posted in Depacon / Depakene / Depakote

The objectives of a study called “The Frequency of Neonatal Morbidity After Exposure to Antiepileptic Drugs in Utero:  A Retrospective Population-Based Study”, written from the Department of Perinatology-Neonatology, Maribor Teaching Hospital in Slovenia, were to determine fetal growth retardation, cerebral hemorrhage, neonatal withdrawal symptoms, and other general malformations in offspring exposed to antiepileptic drugs in… Continue Reading

“Teratogenesis in repeated pregnancies in antiepileptic drug-treated women”

Posted in Depacon / Depakene / Depakote

Today there are many studies available exploring the side effects of antiepileptic drugs (AEDs) taken during pregnancy.  One concern in such cases involves the risk of teratogenesis, which is the malformation of the fetus and/or embryo.  Most studies primarily focus on the initial pregnancy; there is less information available in regards to subsequent pregnancies in… Continue Reading

Danger of AED exposure in utero evaluated

Posted in Depacon / Depakene / Depakote

There are many concerns regarding women of childbearing age who suffer from epilepsy.  There is a clear connection between antiepileptic drugs and their ability to cause harm to a developing fetus or embryo.  Reduced fertility and other menstrual cycle disorders have been linked with exposure to certain antiepileptic drugs.  In an article titled “Teratogenic Potential… Continue Reading

Grim outlook for children exposed to AEDs during pregnancy

Posted in Depacon / Depakene / Depakote

The purpose of a study done by the Faculty of Medicine, University of Rijeka, titled “Epilepsy and Pregnancy: Antiepileptic Drugs Effects on Pregnancy”, was to determine the amount of antiepileptic drugs being used in pregnant women with epilepsy and to analyze possible complications during pregnancy and delivery.  This study was conducted in the University Hospital… Continue Reading

Depacon associated with poor heart development in newborns

Posted in Depacon / Depakene / Depakote

Antiepileptic drugs (AEDs) have shown to increase the risk of major congenital malformations (MCMs) in the offspring of epileptic drugs.  AEDs have shown to have harmful effects on a developing fetus or embryo.  Most doctors would recommend treatment using only one antiepileptic drug, which has shown to have a decreased effect on the rate of… Continue Reading

Fetal hydantoin syndrome associated with in utero AED exposure

Posted in Depacon / Depakene / Depakote

The connection between antiepileptic drugs and their ability to cause damage to a developing fetus or embryo is well documented.  Antiepileptic drugs (AEDs) are clearly connected to an increased risk of major congenital malformations in offspring exposed to the drugs during development.  Author Oguni M, from the Department of Pediatrics, Tokyo Women’s Medical University, at… Continue Reading

Depacon, AEDs found to be highly dangerous for developing children

Posted in Depacon / Depakene / Depakote

The connection between antiepileptic drugs and their ability to cause harm to a developing fetus or embryo has been well documented in the medical world.  Many doctors would advise their epileptic patients’ to be on as few antiepileptic drugs (AEDs) as possible.  This is especially important for epileptic women who are trying to conceive.  Author… Continue Reading

Depacon, antiepileptic drugs dramatically raise risk for birth defects

Posted in Depacon / Depakene / Depakote

Antiepileptic drugs (AEDs) are associated with a wide range of side effects, and the increased risk of major congenital malformations (MCM) to the offspring of women exposed to AEDs during pregnancy is very well known.  In a study called “Factors Influencing the Risk of Abnormal Pregnancy Outcome in Epileptic Women: A Multi-centre Prospective Study”, done… Continue Reading

AEDs, not maternal epilepsy, responsible for birth defects

Posted in Depacon / Depakene / Depakote

Some studies have shown that women with epilepsy have an increased risk for bearing children with major congenital malformations.  And, it has been shown many times that in utero exposure to maternal antiepileptic drugs (AEDs) exacerbates that risk.   The study described below aimed to clarify whether it was maternal epilepsy or in utero exposure to… Continue Reading

FDA: “Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage”

Posted in Cipro, Safety Alerts

Cipro (ciprofloxacin), an antibiotic that has recently been linked to retinal detachment and other nerve disorders, came under fire last week as the US Food and Drug Administration rules that new warnings and usage guidelines be included on its packaging “to better describe the serious side effect of peripheral neuropathy”[1] or, nerve damage. MedlinePlus, an… Continue Reading

Depacon (sodium valproate) linked to spina bifida, other neural tube defects

Posted in Depacon / Depakene / Depakote

Maternal use of antiepileptic drugs is well-known to be associated with elevated risks of major congenital malformations in offspring.  When compared to the general public, the risk for congenital malformations in the offspring of women on antiepileptic medication is roughly 4 to 6 percents, twice as likely as women not on AEDs.  Author Yerby MS… Continue Reading

Research shows: Antiepileptic drugs linked to birth defects

Posted in Depacon / Depakene / Depakote

Epilepsy in women comes with many potential effects on fertility, reproduction, menstrual cycle and sexual development.  Both the disease, and the medications prescribed can have negative effects on a woman’s menstrual cycle and fertility; antiepileptic drugs increase the risk of major congenital malformations (MCMs) in the offspring of women with epilepsy. Author Crawford P. from… Continue Reading

Depacon and similar AEDs connected to serious birth defects

Posted in Depacon / Depakene / Depakote

Carefully and closely-monitored clinical management is extremely important for epileptic women who are trying to become pregnant, for an epileptic woman’s ‘seizure frequency’ or patterns may change during the course of her pregnancy.  Seizure activity and the mothers’ exposure to antiepileptic drugs can cause damage to a developing fetus or embryo.  Author Pack AM. From… Continue Reading

“Guidelines for Care of Women with Epilepsy” warns: AEDs dangerous for fetus

Posted in Depacon / Depakene / Depakote

The harmful effects that antiepileptic drugs may have on a developing fetus are well-known.  Many studies have shown with quite certainty that the amount of antiepileptic drugs (AEDs) a mother uses during her pregnancy is correlated with an increased risk for major congenital malformations (MCMs) in her children.  For this reason alone, most doctors would… Continue Reading