What Are ACell MicroMatrix Side Effects?

ACell MicroMatrix side effects such as fevers, infections, or serious complications such as septic shock and death may occur due to excessive levels of endotoxins.

What Is ACell MicroMatrix?

ACell MicroMatrix is a wound management product which aims to support wound healing by assisting in tissue remodeling. According to ACell’s website, MicroMatrix is appropriate for a variety of wounds such as:

• Diabetic food ulcers;
• Pressure ulcers;
• Venous ulcers;
• Chronic vascular ulcers;
• Partial and full thickness wounds;
• Trauma wounds (abrasions, burns, lacerations, etc.);
• Surgical wounds (donor sites, incision wounds, etc.);
• Necrotizing soft tissue infections;
• Draining wounds;
• And more.

How Does ACell MicroMatrix Work?

ACell MicroMatrix biologic powder wound dressings are approved by the U.S. Food and Drug Administration (FDA) for topical use. The products are reportedly distributed in a powder form and cytal sheet. The MicroMatrix powder can be applied to wounds dry or mixed into a paste with sterile saline to be applied topically. Then, the cytal sheet is hydrated and placed over the powder or paste.

After ACell MicroMatrix is applied, regular wound dressings can be applied. The products are reportedly designed to be absorbable – meaning that dressing doesn’t need to be removed after a certain amount of time.

ACell MicroMatrix products reportedly work through ACell’s proprietary MatriStem UBM™ (Urinary Bladder Matrix) technology. This help includes growth factors, proteins, and other substances which induces rapid healing and acts as a scaffold for healing tissue.

What Are ACell MicroMatrix Side Effects?

In 2011, ACell reportedly discovered dangerous levels of endotoxins in their MicroMatrix products. In some products, endotoxins were allegedly 4.5 to 13.5 times higher than allowed by the FDA’s safety standards.

Endotoxins are commonly found in the cell walls of bacteria such as E. coli. In the human body, endotoxins are released when the immune system targets foreign bacteria. Once released by bacteria, significant side effects can occur.

Unfortunately, the presence of endotoxins in certain products means that ACell side effects may include:

• Fevers
• Infections
• Septic shock – when an infection reaches the bloodstream and prompts the body to release inflammatory chemicals to fight, eventually leading to low blood pressure, respiratory failure, heart failure, stroke, organ failure, and more
• Death

Was ACell MicroMatrix Recalled?

Despite the presence of endotoxins in their ACell MicroMatrix powder, ACell allegedly failed to report the removal of their product from the market. Instead, the company reportedly implemented a “silent recall.”

ACell reportedly removed its 500mg and 1,000 mg MicroMatrix products from the market without informing the FDA that the removal was due to a health risk or even reporting the adverse events associated with the products. Similarly, the company reportedly failed to disclose to doctors that the products were associated with adverse events.

In 2019, ACell was faced with the consequences of their actions when they pled guilty to violating the Federal Food, Drug, and Cosmetic Act (FDCA). As such, the company agreed to pay $3 million to resolve its criminal liability in the ACell MicroMatrix side effects case. As part of the plea deal, ACell admitted to removing over 30,000 MicroMatrix devices due to an endotoxin contamination.

“The FDA will not tolerate the actions of companies that put patients at risk by failing to report the market withdrawal of their medical devices to the FDA,” said Acting FDA Commissioner Ned Sharpless in a Department of Justice press release.

“By not notifying the FDA nor being forthcoming about their reasons for the product removal, ACell executives placed profit above patient safety.”

In addition to paying millions in fines to the government, ACell agreed to pay $12 million to resolve a False Claims Act lawsuit filed by a former employee.

The whistleblower argued that ACell was liable for years of false claims submitted to government healthcare programs such as Medicare. Specifically, ACell’s sales representatives allegedly told physicians that their MicroMatrix products were safe to be used internally despite the products only being approved for external use. As a result, patients who were injured reportedly filed claims with government health programs due to false and misleading representations.

“Neglecting to provide vital medical device information to the FDA, medical professionals, and even the company’s own sales force, posed a significant threat to the lives of patients across the country,” said Maureen Dixon, the Special Agent in Charge for the Office of Inspector General of the Maryland region.

“Compounding that crime, the government contended the company paid thinly-veiled bribes to health providers and stuck taxpayers with inflated bills.”

The ACell MicroMatrix FCA Lawsuit is Case No. ELH-13-1820 in the U.S. District Court for the District of Maryland.

Join a MicroMatrix Class Action Lawsuit Investigation

If you or a loved one underwent surgery to treat internal wounds with MicroMatrix, you may qualify to join a class action lawsuit investigation.

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This article is not legal advice. It is presented
for informational purposes only.