For some women a pelvic transvaginal mesh product has been a god sent. To be able to resume a full active life, without the worry of a leaky bladder, is a true miracle for some women. And, this only became possible with the help of pelvic mesh. The mesh is most commonly used after pelvic [...]
Tag Archives | Transvaginal Mesh
Pelvic Mesh Lawsuits Mount Against Boston Scientific
The list of lawsuits and complaints over the negative adverse effects of pelvic mesh just seems to be getting longer and longer. Another mesh maker, Boston Scientific, has joined makers such as Johnson & Johnson, C.R. Bard, Covidien and others in reporting that their company is sharing in all of the negative attention, as they have [...]
California Couple Wins Landmark Victory in Transvaginal Mesh Case
A common defective medical implant, the transvaginal mesh, has caused a whole lot of agony and grief for women all over our country. But, for one woman, her complications have awarded her 5.5 million dollars, making history in our nation, as this is the first victory of its kind. Christine Scott had a vaginal mesh [...]
FDA Device Chief Says Agency Needs More Authority on Medical Device Approvals
The top FDA administrator stressed that the agency must possess more control in barring faulty products in order to put a stop to lawsuits that resulted from flawed hip implants and vaginal mesh. But since the FDA currently does not have the power to reject a medical device rushed through the fast-track system, even if [...]
Lawmakers Seeking Safety Review In Regards to Transvaginal Mesh & Lap-Band Medical Devices
For the second time, four Democratic lawmakers are seeking hearings into two controversial medical devices, the Lap-Band surgical weight loss device, made by Allergan Inc. and transvaginal meshes made by Johnson & Johnson. In a letter sent last week, the group, led by U.S. Representative Henry Waxman of California, asserts that both transvaginal mesh [...]
FDA Requires Transvaginal Mesh Makers To Seriously Study Risks
According to The New York Times, The Food and Drug Administration issued an order on January 4, 2012 requiring the makers of implantable transvaginal surgical mesh used to treat urinary incontinence in women to study its risks. According to an FDA update, in letters mailed to Johnson & Johnson , C.R. Bard Inc. and 31 [...]
FDA Advisory Panel Weighs Vaginal Mesh Dangers
It is no secret that there has been some majors concerns of using surgical mesh to repair Pelvic Organ Prolapse (POP) (Check out our recent articles on the vaginal mesh dangers here, here and here). Now the Food and Drug Administration (FDA) identified serious safety and effectiveness concerns over the use of the for the transvaginal repair of POP based on a review of adverse events reported to the FDA and an assessment of the scientific literature.
Tougher Regulation Of Vaginal Mesh Not Necessary Says Boston Scientific
In the no surprise department. Boston Scientific released a statement regarding the potential for additional FDA regulations concerning transvaginal mesh safety. According the statement, Boston Scientific believes there is no need for tougher FDA regulation of the mesh.
Public Citizen group calls on FDA for transvaginal mesh recall
A public advocacy group, Public Citizen, founded by Ralph Nader, is asking the U.S. Food and Drug Administration to recall transvaginal surgical mesh products that help repair pelvic organ prolapse and stress urinary incontinence, just as the industry is preparing a broad response.
FDA expresses major concerns over the safety of transvaginal placement of surgical mesh
In a recent FDA Safety Communication, the Food and Drug Administration updated the public on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse.
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Latest Drug Injury News
Underground Railway Dust May Pose Health Risk
Travelling or working on an underground railway for sustained period of time could have health implications due to concentrations of metal-rich microscopic dust particles.
New Study Helps Understand Why Health Care Costs On The RiseAlthough many believe is it medical malpractice suites that are causing the increase in the health care costs, it is actually the fear of them that is partly to blame. Doctors are ordering unnecessary tests and procedures for fear of a patient filing a claim down the road
FDA Issues New Warnings Concerning TolvaptanThe FDA has issued a drug safety communication concerning Tolvaptan, a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia.
New Antiepileptic Drug Causes Blue Discoloration And Vision TroubleAn antiepileptic drug to hit the market has been known to cause vision troubles and skin discoloration. Almost all patients experienced gray/blue skin discoloration who had been taking the pill for two years. More information is needed to better understand the occurrences.
Medical Mattresses Pose Risk Of Infection And ContaminationThe FDA warns that medical mattresses may not be as clean as once perceived. Routine checks on mattresses are advised as any rips, tears, or excessive wear alter the efficacy. The medical mattresses as well as the covers have an expected life depending on the manufacturer, which should not go unnoticed.
Latest Medical Device Injury News
Women 30% More Likely To Need Repeat Hip Implant Surgery
Doctors traditionally believed the larger the size of the implant, the more protective it was against failure, according to Sedrakyan. However, he said his study found regardless of size, women had a higher rate of revision occurrence, so some other factor besides the actual implants may be leading to this effect.
Transvaginal Mesh Lawsuits – Who Is At Fault?For some women a pelvic transvaginal mesh product has been a god sent. To be able to resume a full active life, without the worry of a leaky bladder, is a true miracle for some women. And, this only became possible with the help of pelvic mesh. The mesh is most commonly used after pelvic [...]
Metal-on-Metal Hip Implants Cause Soft Tissue Damage Says FDAHip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip resurfacing. As part of this treatment, they may receive a “metal-on-metal” hip implant in which the “ball and socket” of [...]
Ethicon Recalls Surgical StaplerThe FDA has announced a voluntary global recall of more than 157,000 Ethicon surgical staplers, due to problems with incomplete firing strokes that may cause faulty staple formation, potentially resulting in painful and severe internal complications for the patient. An Ethicon surgical stapler recall was first announced in August, after reports surfaced where surgeons experienced [...]
Another Device Maker Investigated By DOJEarlier this month, cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. According to Forbes, the announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had just been [...]
