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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2012 – “Cardiac erosion is a rare but serious complication of the ASO device”

Posted in Atrial Septal Occluders

Atrial Septal Defect (ASD) is a condition of the heart in which there is an opening between two chambers of the heart, which failed to close after birth.  As a result, the blood pumped through the body has abnormally low levels of oxygen.  One treatment for this condition employs the use of an Atrial Septal Occluder (ASO), which seals the opening between the two chambers.  One of the advantages of ASO usage is that it is minimally invasive, and doesn’t require surgery; the device is implanted through a vein.  ASO usage has unfortunately led to numerous complications due to erosion after implantation.  In many cases these complications can be fatal if left untreated.

Many studies have been conducted to assess the safety of ASOs.  One such study was conducted by Crawford et al. and published in Medline.  The title of the study is “Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature,” with the stated objective being “to systematically review all cases in the literature of erosion associated with atrial septal defect (ASD) occluder devices.”

There have been several reports of erosion associated with implantation of this device.  According to this study, calculating the statistical likelihood of erosion occurring post-implantation is not currently possible due to an unknown number of implantations and an unknown number of reported complications.  However, the estimated likelihood of erosion is under 1%.

In this study, the authors concluded, “Cardiac erosion is a rare but serious complication of the ASO device. Erosion events are most often ascribed to device over-sizing or deficient retro-aortic rims; however, both consensus and evidence for a cogent risk factor(s) is lacking.”  The authors stated that the causes of these complications have yet to be determined and that further research must be conducted.

Because so many people have used amplatzers but were unaware of the risk for erosion associated with ASOs, many ASO erosion lawsuits have been filed.  If you or a loved one used an ASO and experienced amplatzer side effects, you may be entitled to significant financial compensation for the injuries suffered through no fault of your own.

For more information, please do not hesitate to contact our team of ASO lawyers at the information provided below.  We have the skills, resources, and experience required to win the justice you deserve, even from the largest of medical device manufacturers.  Call today and see how we can help!

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.