It is within the context of these “other” uses, indications for which AlloDerm LifeCell was not originally approved by the US Food and Drug Administration (FDA), that appears to lay at the root of all the trouble.
To explain, AlloDerm by LifeCell is akin to a trip through a Buck Rogers movie. AlloDerm, according to reports, is fashioned from dermis (skin) harvested from cadavers, which then undergoes a rigorous processing routine that sees all the original cells removed to diminish the likelihood of rejection by the recipient, and long term is supposed to provide rapid revascularization and repopulation of the recipient’s own cells.
Something out of a sci-fi movie, to be sure. And apparently successful, as LifeCell Corp. boasts hundreds of thousands of successful procedures as an alternative to traditional skin grafting.
But for some patients there have been problems with their AlloDerm reconstructive surgery. For hernia repair, for example, there have been reports of infection, tearing of the AlloDerm patch, perforations and other problems.
A small study published in the professional journal Hernia in June 2008 followed the outcomes of 70 patients having received the AlloDerm product for hernia repair. The study found an overall complication rate of 24 percent, with 10 of the 70 patients studied requiring revision surgery due to AlloDerm infection and other complications.
The FDA, which approved the LifeCell product in 1994, carries an adverse event report on its official “MAUDE” adverse event page, detailing the plight of a patient who underwent a bilateral mammary reduction with an AlloDerm by LifeCell sling in 2008 (the same year as the aforementioned study). According to the adverse event report, the patient was re-admitted to the hospital four days later due to reports of a foul odor and apparent AlloDerm infection. The patient underwent an incision in her right breast for drainage, and removal of two units of AlloDerm by LifeCell that exhibited a foul odor and presented signs of apparent infection.
READ MORE ALLODERM SKIN GRAFT LEGAL NEWS
LifeCell Corp. is identified as a subsidiary of Kinetic Concepts Inc. The two were named in a lawsuit filed in February 2012 alleging that KCI and LifeCell improperly marketed AlloDerm Regenerative Tissue matrix for use in hernia repair since 2000. The case has an insurance unpinning, and is Illinois Union Insurance Co. v. Kinetic Concepts Inc. et al., case number 5:12cv00137, in the US District Court for the Western District of Texas.