The off-label use of Acellular Dermal Matrix (ADM) products in implant-based breast reconstruction can result in post surgical complications and problems for patients up to two years after the surgery according to a recent analysis by the FDA.
Off-label use not approved by FDA
Accellular Dermal Matrix is a type of surgical mesh that is developed from human or animal skin. It has been approved by the FDA for specific use such as hernia surgery and more recently many surgeons specializing in breast reconstruction after a mastectomy have been using the product off-label. The off-label use of ADM for breast reconstruction has never been approved by the FDA and a recent analysis found that some patients suffered complications up to two years after the surgery.
Complications occurred mostly with FlexHD and AlloMAX
The four following brands of ADM are commonly used in breast reconstruction: FlexHD, AlloMax, SurgiMend and AlloDerm.
The FDA analysis found a much higher rate of infections, explantation and reoperations in patients who received FlexHD and AlloMAX compared to patients who received SurgiMend or AlloDerm or patients who did not receive ADM.
Adverse events should be reported
The FDA is recommending that surgeons not only report any adverse event that might have occured to their patients when using ADMs but also consider the risks of using these products off-label.
Patients should be informed and pro and cons discussion with the surgeon must take place before surgery
Additionally, patients should be informed and surgeons should discuss with them the risk and benefits of using ADM or not in their breast reconstruction procedure. Surgeons should also be aware that these products were never approved by the FDA for breast implant reconstructions.
The FDA does not recommend surgeons to re-operate or to remove the implanted ADM as a preventive measure.
More information from the FDA can be found here
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