The U.S. Food and Drug Administration (FDA) is informing patients, caregivers and healthcare providers that certain surgical mesh products used in implant-based breast reconstruction could pose a higher risk of complications or problems for those who get them. According to the FDA alert, these acellular dermal matrix or ADM products could cause side effects and complications.
What Are the Problems?
There are many different methods for reconstructing the breast after a mastectomy or surgical removal of the breast. For patients who will have breast reconstruction using implants, the surgeon may use just the implant or both an implant and an ADM. The FDA has not cleared or approved ADM or mesh for use in breast reconstruction. The agency informs healthcare providers and patients about its recent analysis and requests prompt reporting of adverse events so the risks can be better understood.
Patients who were implanted with FlexHD, made by MTF Biologics or AlloMax, manufactured by BD, were more likely to suffer from infections or problems that required another surgery within two years compared to patients who were treated with other mesh or no mesh, FDA officials said. Both products are made of human or animal skin.
While the FDA has approved some types of ADMs for hernia surgeries, they are not approved for post-mastectomy breast reconstruction surgeries. However, the FDA says off-label use of these products has increased over the last several years for implant-based breast reconstruction. The FDA is currently not recommending surgery or removal of the mesh. Instead, they are asking that anyone who has problems after breast reconstruction with ADM to file a report through MedWatch, which is the FDA’s Safety Information and Adverse Event Reporting System.
Defective Medical Devices
Regarding defective products, there is no question that defective medical devices have a devastating impact on patients. When a medical device fails, the consequences are typical that the patient will need to have the device removed surgically or endure side effects of complications because of the device. This means that victims are forced to undergo additional, unnecessary surgery that could’ve been avoided and endure the pain, discomfort, and expenses involved in such procedures.
Suppose you or a loved one has been affected by these or other medical devices. In that case, you may be able to seek compensation for your injuries, damages, and losses by filing a product liability claim against the manufacturer. An experienced product defect lawyer who has successfully handled defective medical device cases will be able to help you better understand your legal rights and options.
Source: https://www.fda.gov/medical-devices/safety-communications/acellular-dermal-matrix-adm-products-used-implant-based-breast-reconstruction-differ-complication
