Category: Medical Devices
Heart Devices Failed in Thousands of Patients over Last 10 YearsNovember 6, 2017 | Category: Medical Devices
The Inspector General’s office in the Health and Human Services Department (HHS) said in a report released Monday, October 2, 2017 that officials need to do a better job of tracking costly product failures to protect patients.
How and Why Do Unsafe Medical Devices Get Approved By the FDA - UpdateJanuary 9, 2015 | Category: Medical Devices
This is an update to a blog we wrote in November 2014 on 'Does the FDA adequately review medical devices?'. This issue is still in the news with updates from reporters who are researching the matter. We feel this is important information for everyone.
FDA Renews Warning Against Using Laparoscopic Power Morcellators on Uterine FibroidsDecember 11, 2014 | Category: Medical Devices
Just before Thanksgiving, the Food and Drug Administration renewed its original safety communication issued in April 2014 to once again warn against the use of laparoscopic power morcellators to remove fibroids and/or the uterus. More specifically, the Administration wants manufacturers to include certain safety statements "in the form of a boxed warning and two contraindications."
Does the FDA adequately review medical devices?November 12, 2014 | Category: Medical Devices
Sara Murray of the Wall Street Journal reported in September that the majority of moderate-to-high-risk medical devices approved by the FDA lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law.
Senators Urge FDA To Get More Power Morcellators Pulled From The MarketSeptember 20, 2014 | Category: Medical Devices
Most Ft. Myers personal injury lawyers, like Randall Spivey, know that individuals sustain serious injuries or even die "as a result of unwittingly using defective medical products and devices, most of which are recommended or prescribed by their physicians and approved by the U.S. Food and Drug Administration (FDA)." Recently, some U.S. senators asked the FDA to reach out to the manufacturers of power morcellators in an effort to get them to take those devices off the market due to the risk of...
The Issues Surrounding The Transvaginal MeshSeptember 1, 2014 | Category: Medical Devices
There have been numerous lawsuits filed on behalf of millions of women all around the country against the manufacturers of transvaginal mesh (TVM) and mesh sling devices. Many women who have experienced issues with their pelvic organs have made the decision to be implanted with a TVM or mesh sling in an effort to help fix stress urinary incontinence or pelvic organ prolapse.
Defective Medical Devices Product Liability ClaimsMarch 3, 2014 | Category: Defective Products, Medical Devices
Each year many Americans are injured and or killed as a result of defective products, according to the he U.S. Consumer Product Safety Commission (CPSC).Millions of Americans depend on advanced medical devices to correct health issues that impede their daily life. While most benefit from these devices, some patients suffer injuries as a result of faulty medical products.
Alert - Lee Memorial Hospital, Fort Myers, FL Sends Letters to Open Heart Surgery PatientsOctober 23, 2012 | Category: Medical Devices
262 former patients were notified October 18, 2012 by Lee Memorial Hospital that they were treated with a cardioplegia solution the hospital received from the New England Compounding Center (NECC). Attorney Randall Spivey of Spivey Law Firm, Personal Injury Attorneys, P.A. urges, "If you, your loved one or someone you know has been given an NECC product are experiencing any symptoms, contact your doctor immediately, then contact us.