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 [...]
Topic | Medical Device Safety News RSS feed for this section
Heart Stent Label Gets New Warning- Let’s Hope People Are Reading The Label!
The new Boston Scientific heart stent is getting a new warning added to their label, according to The U.S. Food & Drug Administration (FDA), who is requiring it. The agency is doing so, even though they are still investigating a rare and serious health issue with Boston Scientific Corp.’s new device, the Promus Element. The [...]
Recall Of Operating Tables Could Mean Life Or Death For Surgical Patient
Imagine if you will the scenario of you being operated on and all of a sudden the operating table suddenly moved or tilted during the surgery. I honestly couldn’t imagine. But, apparently there have been a number of reported injuries to the FDA of this exact thing happening. Reports that Mizuho operating tables could suddenly [...]
Lawmakers Questioning 2 Medical Devices That Are Causing Concern For Many
A group of U.S. lawmakers are calling for an investigation into a growing number of reported problems with 2 medical devices that are causing major concerns for many, metal-on-metal artificial hips, as well as Wingspan brain stents. Democrats on the House Energy and Commerce Committee wrote a letter to several Republican chairmen on October 12, [...]
Mirena Patient Seeking $2 Million in Damages From OB Clinic
A Virginia woman has filed a medical malpractice lawsuit against an OB/GYN clinic and her doctor for allegedly leaving a Mirena IUD (intra-uterine device) birth control floating in her system.
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 receiving many complaints from patients receiving hip replacement devices
The federal government received a surge in complaints in recent months about failed hip replacements, suggesting that serious problems persist with some types of artificial hips even as researchers scramble to evaluate the health dangers, according to an article found at The New York Times.
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.
GET HELP NOW!
Latest Drug Injury News
Heightened Thrombosis Risk with Birth Control Patch and Ring
A BMJ study has found more evidence that women using the transdermal contraceptive patch or vaginal ring do indeed face higher thrombosis risks than those taking their contraceptive orally. Using Danish national registries, researchers studied over 1.5 million women without prior thrombotic disease or cancer, who were not pregnant. Overall, the incidence of venous thrombosis [...]
Is Your Heartburn Medication Putting You At Risk?According to a new study, your heartburn medication could be putting you at risk for a nasty stomach bug! The infection, Clostridium difficile infection, also called C. difficile or CDI, is a hard-to-cure infection that causes severe diarrhea that has recently been linked to proton pump inhibitors (PPIs), the most powerful class of antacid drugs. [...]
Cipralex and Abnormal Heart RhythmsHealth Canada is informing Canadians of a labeling update for the prescription drug Cipralex (Escitalopram) regarding a dose-related risk of abnormal heart rhythms. The risk is dose-related, 20 mg per day is still the maximum recommended dose for most patients. Before starting Cipralex, talk to your healthcare professional. If you have had any heart problems, what other medications you [...]
Florida Compounding Pharmacy Linked To Rare Fungal Eye InfectionsWhats that in my eye?! Thirty-three cases of a rare, but serious, fungal eye infection have been confirmed across seven states. Federal officials are announcing that the infection stemmed from products mixed in a Florida compounding pharmacy. it seems the victims underwent some sort of an eye procedure, either a surgery or injections. Of these, [...]
Multaq and Death By Heart ProblemsMultaq, also known as Dronedarone, is used to treat heart patients that had atrial fibrillation, which is a rhythm disorder that could make the heart beat fast and irregular. It’s also used to treat atrial flutter, which also causes the heart to beat fast, but is still considered regular. However, this drug is known to [...]
Latest Medical Device Injury News
More Sufferers File Lawsuits Against DePuy Orthopaedics
Two more people who’ve suffered serious injuries blamed on the defective and recalled DePuy Orthopaedics ASR hip implant are the latest to join a growing federal class-action lawsuit against the medical device firm and its parent company, Johnson & Johnson. The plaintiff’s are being represented by the law firm of Parker Waichman LLP and are [...]
Metal-on-Metal Hip Implant Finds No Increased Cancer Risk?We have written countless articles discussing the dangers of metal-on-metal implants, yet a new study is downplaying the potential dangerous effects, such as the risk of cancer. The recent study was published in the British Medical Journal which analyzed cancer rates among patients with metal-on-metal implants versus patients with other types of implants as well [...]
St. Jude’s Wants Study Retracted Due To InaccuracySt. Jude Medical has asked the Heart Rhythm Journal to retract a study published last month that linked its Riata line of internal defibrillator leads to more 20 deaths. In a statement issued by St. Jude, the company asserted the Riata lead study was biased and based on inaccurate facts. According to the Heart Rhythm [...]
Vaginal Mesh Lawsuits Claim Painful Erosion, Organ DamageAn estimated 35,000 women who suffered through bladder control problems brought on by aging, child birth, and a variety of other causes. The lives of those who had adverse reactions to vaginal mesh were literally ruined as many experienced crippling pain and permanent scarring damage from the procedures involved in the insertion and necessary removal of the vaginal mesh.
If you or a loved one suffered vaginal erosion call us immediately at 1-800-810-3457.
FDA Reposts Thoratec HeartMate II LVAS Class I RecallA recall of Thoratec’s HeartMate II Left Ventricle Assist System (LVAS) that was first announced in February has been designated Class I, the U.S. Food & Drug Administration’s (FDA) most serious type of recall. The HeartMate II LVAS is a heart pump which is used as a bridge to transplantation in heart transplant candidates at [...]
