Modern Medicine has come a long way. The Pharmaceutical Industry as we know it began in 1928 when Sir Alexander Fleming discovered Penicillin. The discovery of this antibiotic from the mould, Penicillium notatum, was stated by Time Magazine as the discovery that would change the course of history. This infection-fighting antibiotic inspired other scientists to produce their own synthetic versions of this drug that would go on to treat some of the most common and serious infections and diseases known to mankind.
Since 1994, the Biotechnology Company, LifeCell, has been a pioneer in regenerative medicine. Their success can be attributed to rising sales of their flagship product, AlloDerm.
AlloDerm Regenerative Tissue Matrix, is an Accellular Human Dermis, which is an organic tissue graft produced through a unique non-damaging process that allows the body to mount its own tissue regeneration process. Essentially, the skin, which is derived from cadavers, goes through a process to remove all off the epidermis and dermis skin layers leaving only the collagen and elastin framework of the skin. This process removes that elements of the skin that would ordinarily be rejected by the recipient leaving only what will be accepted by the new body, and ultimately assist in the cellular rebuilding process.
In 1994 AlloDerm was originally developed and used for grafts for burn patients. In the early 2000s it began being marketed for internal procedures. Currently, AlloDerm’s most common uses include hernia repair, abdominal wall reconstruction, and postmasectomy breast reconstruction. AlloDerm is also used by dentists for soft tissue and gum reconstruction.
As stated on LifeCell’s website. AlloDerm has been used successfully in more than one million grafts and implants to date. However, nothing is perfect, and it is impossible to measure success without acknowledging failures.
A 2008 study of 70 hernia surgery patient found that AlloDerm’s overall complication rate was 24 percent. There has been no official Alloderm Recall, however, the FDA has issues warnings following a number of Adverse Event Reports received from 2007-2009. The most common complaints among AlloDerm Recipients include:
• Swelling • infection • Abscesses • Pain/Soreness • Inflammation • Additional Surgical Procedures Required • Hernia Recurrence • Bowel Obstructions & Bowel Complications
Recent studies have shown an extremely high rate of hernia recurrence. One of the main causes of hernia recurrence is the stretching or thinning of the Alloderm. This means additional corrective surgeries may be required. While abdominal hernia repair are known to have a high recurrence and failure rate, patients who received AlloDerm to repair pelvic prolopase or breast reconstruction are also requiring additional repairs to do the thinning and stretching of the tissue matrix.
One of the most common advisory statements in the reports on AlloDerm’s high complication rate, and risk of hernia recurrence, is not that it needs to be removed from the market, but that LifeCell needs to improve their product. AlloDerm can be improved by improving the processing technique used to develop AlloDerm . The fundamentals of its processing is the source of its problems – when they process the skin they remove dermis but not elastin which creates natural stretch (i.e. elasticity) in human skin. By leaving the elastin in AlloDerm the implants have a natural propensity to thin, stretch and tear esp. when placed under the pressure and tension that occurs in the human abdomen. They should have done enough testing to figure this out before they put it on the market.
An organic product designed not just to pass life sustaining qualities from one human to another, but to also help, the recipients own cells regenerate is a miracle of modern science. This is a great idea that, as studies suggest, just needs improvement for better long-term results. Perhaps the growing number of AlloDerm lawsuits brought by individuals who suffered from hernia recurrence, will give LifeCell the nudge needed to make this product better.
It has been almost 100 years since Fleming’s World Changing Discovery. Since then, the Industry it spawned has seen its fair share of success and failure. As ailing consumers we need our medical devices, prescriptions, and tissue implants that the pharmaceutical industry has made possible. All we ask is for is problem recognition and constant improvement. Had no one thought to improve an existing product, the pharmaceutical industry would not be what it is today.