Medical Devices
New FDA Rule May Allow Defective Device Manufacturers to Delay Reporting Problems
Every five years, the Food & Drug Administration and medical device manufacturers renegotiate a deal regarding the costs of reviewing medical devices. The newest negotiation would allow manufacturers to potentially report malfunctions in their products 4 times a year, as opposed to every month. From the New York Times: “The current draft compels the F.D.A.…
Read MoreEthicon Physiomesh Hernia Mesh Product Liability Lawsuits for Injuries and Revision Surgeries
Physiomesh is a product manufactured by Ethicon, a subsidiary of Johnson & Johnson, to be implanted into human bodies to repair hernias. The product was approved by the U.S. Food and Drug Administration (FDA) in April 2010 through the agency’s 510(k) process. This fast track that is the 510(k) process allows device manufacturers to skip…
Read MoreDangers of C-QUR Atrium Mesh Explained by South Carolina Product Liability Attorneys
C-Qur is a mesh implant, manufactured by Atrium Medical Corporation (AMC). It was approved by the United States Food & Drug Administration (FDA) in 2006 for various internal medical repairs, including hernia repair, surgical wound repair, and chest wall repair. The mesh is made from polypropylene, a polymer plastic. Hospitals and doctors began aggressively utilizing…
Read MoreShoulder Implant Recalled Over High Risk of Fracture
In mid-February, the US Food & Drug Administration issued a Class I recall for a type of shoulder implant. The device, manufactured by Zimmer Biomet, is being recalled because of a high risk of fracture that can have severe consequences, including the need for additional surgery, serious infection and loss of limb function. The Class…
Read MoreTransvaginal Mesh Officially Reclassified as a Dangerous Medical Product
Right now, there are thousands of women across the country embroiled in defective product lawsuits over a product called transvaginal mesh, or TVM. Originally designed to fix hernias, TVM has been used primarily to fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI), two conditions common to older women who have given birth or…
Read MoreMcGowan, Hood, Felder & Phillips, LLC, Wants to Warn You of New and Dangerous Defective Drug Alerts for Janumet and Incivek
New risks discovered for users of Janumet If you have taken Janumet for Type 2 diabetes or Incivek (Telaprevir) for hepatitis C, you may be at serious risk. This special report is intended for immediate release to anyone who has been prescribed these drugs. Janumet is a combination of metformin and sitagliptin. It is prescribed…
Read MoreFeds to Probe FDA’s Power Morcellator Approval
The United States Government Accountability Office (GAO) announced recently that it will begin an investigation into the Food and Drug Administration’s approval of power morcellators for use during surgery. Power morcellators are used to cut and shred tissue for removal during minimally invasive surgeries. The device consists of a hollow suction tube with cutting jaws…
Read MoreDiabetics Taking Onglyza and Kombiglyze XR Are At Risk
Onglyza and Kombiglyze XR are two related medications that help Type 2 diabetics to control their blood sugar levels. These drugs have recently been linked to an increased risk of heart failure and acute pancreatitis leading to precancerous changes. Type 2 diabetics produce insulin, but their bodies either do not produce enough or are unable…
Read MoreDefective Scope Causes Infection and Death
Renate Winkler underwent a medical procedure in 2013. Shortly after, she was diagnosed with carbapenem-resistant Enterobacteriaceae, or CRE. CRE is a healthcare-acquired infection, or HAI. Winkler passed away December 2013 as a result of CRE infection. According to Business Wire, her family has recently filed a lawsuit against her hospital, Advocate Lutheran General Hospital, and…
Read MoreDefective Medical Devices – Hip Replacement Recall Lawsuits in South Carolina
As the population of South Carolina population and the rest of the United States ages, health issues such as the deterioration of the hip joint become more common. People experience pain and stiffness in the hip and difficulty walking, which can often lead to the need for hip replacement surgery. A surgeon takes an artificial…
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