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“Silent Recall” of ACell MicroMatrix Prompts Class Action Lawsuit Investigation

The ACell MicroMatrix Class Action Lawsuit Investigation

A class action lawsuit was filed against ACell Inc. for surreptitiously recalling certain MicroMatrix products that were found to pose a risk of endotoxin contamination while keeping others on the market.

Consumers reported suffering adverse health effects after using the product internally in their surgeries. The ACell MicroMatrix is a wound-dressing device that is supposed to be only used topically in surgery and permitted by the FDA for only such use.

MicroMatrix use has been reported to cause adverse effects because of the endotoxin exposure to the product. These adverse effects include fever, infection, septic shock, and death.

Did you or a family member undergo surgery that used MicroMatrix power wound dressing? Contact us today to see if you are entitled to join the ACell MicroMatrix “Silent Recall” lawsuit investigation.

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The Lowdown on ACell’s Micromatrix

Numerous medical devices made from porcine urinary bladder material were manufactured by ACell Inc., some of which have been approved for internal surgical implantation with the rest as a topical wound dressing.

MicroMatrix, a powder wound dressing from ground porcine bladder sheets, was approved by the U.S. Food and Drug Administration (FDA) in June 2006 for topical use only, on condition that the product displays truthful literature in its “Indications for Use”, as recommended:

MicroMatrix® is intended for the management of topical wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds.

The class action lawsuit claims that “ACell added the word ‘topical’ to the labeling and chose not to submit a premarket application for MicroMatrix concerning any internal use.”

The company discovered in 2011 that certain lots of MicroMatrix contained endotoxin levels that were 4.5 to 13.5 times higher than FDA safety standards but did not issue a recall. ACell instead sent some products to be tested to a third-party company in 2012 which reported that the level of endotoxins was actually more than 31 times higher than FDA safety standards.

ACell consequently removed some MicroMatrix products from the market, its 500mg and 1,000mg variants, but retained its 100mg and 200mg devices. These devices, however, still were reported to contain endotoxin levels higher than the FDA safety standards.

Manufacturers are required by federal law to report to FDA any removal of medical devices due to health risk-related concerns. ACell, however, violated this by concealing the recall from both the FDA and from medical professionals.

The lawsuit also accuses the company’s sales representatives of failing to disclose to medical professionals that the MicroMatrix product contained elevated endotoxin levels or that the company recalled the higher dose products because of the same issue. ACell also failed to report to the FDA several adverse events that were associated with the MicroMatrix product.

According to the lawsuit, “Despite the FDA warning concerning internal use, and ACell’s decision not to submit a premarket application for MicroMatrix concerning any internal use, ACell chose to market MicroMatrix for internal use. ACell management not only directed but also incentivized its sales force to sell MicroMatrix for a variety of internal uses that the FDA had not cleared.”

Because of this, medical professionals and facilities used the product internally on consumers who complained of suffering and experiencing adverse health outcomes and injuries that directly resulted from the use of the product which incurred and continues to incur the consumers with additional expenses.

Editor’s note on the ACell MicroMatrix Class Action Lawsuit Investigation:

This piece is written about the recent ACell MicroMatrix Lawsuit Investigation. If you are considered eligible to be among the class of consumers described in the class action lawsuit investigation, you may eventually be able to participate in receiving any compensation the court may award.

If you believe that what is alleged in the ACell MicroMatrix Class Action Lawsuit Investigation has affected you, please don’t hesitate to reach out to us.

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We’d be happy to help you take a step in the right direction, fight this issue, and better enable you to join in on any potential consumer class action. If interested, please send an email to Outreach@ConsiderTheConsumer.com, find us on Twitter or Facebook, or even connect with us directly on our website! We look forward to hearing from you all.

Similarly, please check out our current list of Class Actions and Class Action Investigations, here.

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