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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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.
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.
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.
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.
Expectant mothers who take the popular anti-epileptic drug valproate during pregnancy should be aware that there is an increased risk for their child developing autism compared with children of women who did not take the epilepsy drug, according to a recently published Danish study. Valproate is a drug used for the treatment of epilepsy and other [...]Cough Syrup Responsible For Over 36 Deaths
Pakistani authorities are investigating allegations that cough syrup has killed at least three dozen people, a government official has announced, making this the second time in recent months that medicine is suspected of causing multiple deaths. The deaths from the cough syrup occurred in the eastern city of Gujranwala and nearby villages, said local official [...]Merck Settles Vioxx Class-Action Lawsuit
In almost a decade old battle, Merck & Co. Inc. has agreed to settle a class action lawsuit filed on behalf of Missouri consumers over its prescription pain reliever Vioxx in a deal that could cost the drugmaker up to $220 million, lawyers for the consumers said. According to CNBC, the agreement announced on November [...]Certain Antidepressants May Raise Lung Risk in Newborns
Antidepressant usage by pregnant women has been a controversial subject for quite some time. Once a woman finds out she is pregnant, she, along with the advice of her doctor, has a very difficult decision to make. There have been countless studies that have proven the dangers of continuing the medications and the effects on [...]Pradaxa Is Linked To Bleeding Death, So Why Is It Still On Market?
A recent article written by The New York Times addresses an issue that we have been talking about for quite some time, Pradaxa and the bleeding deaths linked to the drug. Pradaxa is an anticlotting drug that was believed to be better than the decades old warfarin. But, unfortunately the drug has its flaws, and [...]
Hip 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 Stapler
The 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 DOJ
Earlier 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 [...]A Medical Device Horror Story
CNNMoney describes the chilling details of the bone cement horror stories surrounding the medical device company Synthes. In 2009 the U.S. attorney in Philadelphia accused the medical device manufacturer of running illegal clinical trials — essentially, experimenting on humans. Between 2002 and 2004, Synthes tested a product called Norian XR, a cement that has a [...]Non-FDA Approved Stryker Surgical Device Recall And Alert
Stryker Neptune Waste Management System is the subject of a recent FDA recall and safety alert. The non-FDA approved device can cause bleeding as well as soft tissue, muscle and vital organ damage. The Stryker Neptune Waste Management System is used during surgical procedures to collect fluid waste from the patient. The Neptune 2 Ultra [...]