Acellular Dermal Matrix Product Lawyer

Our law firm is currently handling lawsuits on behalf of individuals who have received certain acellular dermal matrix (ADM) products during breast implant reconstruction surgery. Lawsuits against manufacturers of affected ADM products claim that the they present a greater risk of medical complications than other ADM products or surgery without ADM products.

What Do We Know about Acellular Dermal Matrix Product Lawsuits?

ADM is a form of surgical mesh that is commonly used in breast implant reconstruction surgery. After a mastectomy, breast implant reconstruction can be performed using only breast implants or using breast implants with ADM. However, ADM has not been approved by the FDA for use in reconstructive surgical procedures of the breast. Patients should be aware that certain ADM products have a greater risk of complications and are not approved by federal regulatory authorities.

Acellular Dermal Matrix Product Injuries

The injuries associated with ADM products include infection, seroma (buildup of fluids where tissue has been removed), skin necrosis (tissue death from trauma, injury, or toxin exposure), cellulitis, implant removal, revision surgery, and infection. The Food and Drug Administration (FDA) has recommended that surgeons report these adverse events and also consider the risks of off-label uses of ADM.

list of potential damages

Acellular Dermal Matrix Products and the FDA

ADM has been approved for use in some types of reconstructive procedures, but the FDA has not approved ADM specifically for breast reconstruction surgeries. Nevertheless, ADM has been frequently used in the last few years for off-label purposes.

The FDA has concluded that two ADMs – Flex HD and Allomax- have an increased risk of complications based on its analysis of a study known as the Mastectomy Reconstruction Outcomes Consortium (MROC). MROC collected data from 11 health centers that perform many reconstruction surgeries and found a higher rate of reoperation and infection in patients who received the Flex HD and Allomax brands than in patients who were implanted with competing brands AlloDerm or SurgiMend ADM brands or the control group that did not receive ADM products, as measured within two years of surgery. The FDA noted similar results from other peer-reviewed publications.

The FDA’s safety communication advised that Flex HD and Allomax carry an increased possibility of surgery, implant removal, and infection than other ADMs or surgery without ADM products.

Contact our Sayville Acellular Dermal Matrix Product Attorney

The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation.