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AlloDerm Complications
 

AlloDerm Complications

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AlloDerm Complications: Hernia Recurrence - Serious risks have been associated with the Alloderm hernia mesh. The mesh is used to surgically repair a hernia and to promote tissue growth in the area of ...

AlloDerm Complications: Hernia Recurrence - Serious risks have been associated with the Alloderm hernia mesh. The mesh is used to surgically repair a hernia and to promote tissue growth in the area of the hernia.However, Alloderm hernia mesh failures have been reported at a significantly higher rate than failures of other types of hernia treatments. The failure can result in pain and complications. The failure can be so significant that it allows the hernia to recur and requires further invasive surgery.

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    AlloDerm Complications AlloDerm Complications Document Transcript

    • AlloDerm AlloDerm, or AlloDerm® Regenerative Tissue Matrix  is a kind of skin graft material derived from cadaveric dermis, or donated skin, made by LifeCell Corporation. The human skin goes through a processing and purification process by LifeCell is derived from cadaveric dermis and undergoes non- damaging proprietary processing that removes cells. What are the Uses of AlloDerm? The first use of AlloDerm was in skin replacement procedures for burn victims. It is now common in procedures on the heart, cornea, bone and other tissue and in oral, cosmetic, dermatologic, plastic and reconstructive surgeries. AlloDerm is also used for hernia repair surgeries.  When used for hernia repair, AlloDerm typically serves the purpose of reconstruction, repair or substitution of tissue. Unfortunately, in many cases, the AlloDerm implant stretches or fails resulting in a hernia recurrence and requiring additional surgery. AlloDerm Complications: Hernia Recurrence Serious risks have been associated with the Alloderm hernia mesh. The mesh is used to surgically repair a hernia and to promote tissue growth in For more information contact: the area of the hernia.However, Alloderm hernia mesh failures have been Anapol Schwartz, P .C. reported at a significantly higher rate than failures of other types of hernia (866) 735-2792 treatments. The failure can result in pain and complications. The failureThomas R. Anapol, Esquire or can be so significant that it allows the hernia to recur and requires further Michael H. Monheit, Esquire invasive surgery. ©2012 All Rights Reserved.MEDICAL DISCLAIMER: This PDF is not designed to and does not provide medical advice, professional diagnosis, opinion, treatment or services or otherwise engage in the practice ofmedicine, to you or to any other individual. Please use this information to help in your conversation with your physician. This is general information and always seek the advice of yourphysician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard or delay seeking professional medical advice or treatmentbecause of content found in the PDF, website, or newsletter.ATTORNEY DISCLAIMER: This PDF is dedicated to providing general public information regarding legal rights. None of the information on this PDF is intended to be formal legaladvice, nor the formation of a lawyer or attorney client relationship. Please contact a Lawyer for information regarding your particular case. This PDF is not intended to solicit clientsoutside the states of Pennsylvania, New Jersey, Ohio, West Virginia and Arizona.
    • Studies of patients who had acellular human dermis (AHD), or AlloDerm, implanted to repair an abdominal hernia have the shortest follow-up period and the highest overall failure rate compared to patients repaired with other hernia repair products. The literature shows an apparent lack of long-term follow-up studies on patients who had AlloDerm used to repair his or her hernia. When physicians use AlloDerm on hernia repair patients, corrective surgeries are sometimes necessary. Recent reports published by the U.S. National Library of Medicine indicate that further design improvements are necessary in order for AlloDerm to be a good option for hernia repair. In one particular study, between June 2002 and March 2005, 15 out of 33 AlloDerm patients developed a bulging or diastasis at the repair site. In fact, this study showed that postoperative hernia recurrence and diastasis were a major problem with the AlloDerm mesh. In another report entitled “Results of AlloDerm Use in Abdominal Hernia Repair,” the most common complication with AlloDerm use for hernia repair was hernia recurrence with 24 percent experiencing this complication. If you have been injured by AlloDerm and you need professional legal advice, our Pennsylvania personal injury lawyers can answer your questions. Is AlloDerm Safe to Use on Hernia Repair Patients? Because of the complex structure of human tissue, it is imperative that your physician understand the nature of the mesh he/she uses before utilizing it during a procedure. The fabrication of AlloDerm involves a proprietary method of “purifying” donated skin from cadavers. This produces a dermis that is free of cells that can cause an antigenic response in the recipient. The process reduces the skin to a basement membrane and dermal collagen matrix. LifeCell promotes AlloDerm as a strong and safe product for the repair of abdominal hernias. Recent studies show an extremely high rate of hernia recurrence in patients whose abdominal hernias are repaired with AlloDerm. In other words, patients whose abdominal hernias were repaired with AlloDerm regularly have hernias come back causing significant pain and requiring additional surgery. Current reports suggest that longer-term results are needed as AlloDerm graft stretching may occur in longer follow-up studies. Common adverse events include hernia recurrence (your hernia comes back), additional hernia, abdominal pain, disfigurement, and other complications related to abdominal hernias.Copyright © 2012 All rights reserved. Anapol Schwartz, PRead more information online at www.anapolschwartz.com. .C. AlloDerm ||
    • The most frequently reported complications include the following:  Hernia recurrence (your hernia comes back)  Multiple hernia recurrence  Additional surgery to remove the AlloDerm  Additional surgery to replace the AlloDerm  Abdominal pain  Disfigurement Injuries also include inflammation, swelling, pain/soreness, abscess and infection. There has been no FDA recall for AlloDerm hernia repair biologic mesh since 2005. At that time LifeCell Corporation of Branchburg, New Jersey proceeded with a voluntary recall of certain AlloDerm, Repliform, and GraftJacket products. The AlloDerm recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization. Specifically, the company recalled all lots of product that were produced using tissue from Biomedical Tissue Services (BTS). LifeCell promptly notified the FDA and all relevant hospitals and medical professionals. All other BTS inventory remained on hold until the discrepancies in the donor documentation could be resolved. According to some recent studies three patients had the mesh placed in a contaminated field with no resultant sequela, and there were no hernia recurrences. Patients also had a significant degree of discomfort and pain during the immediate post-operative period. The use of the AlloDerm mesh resulted in eight hernia recurrences. Fifteen of 33 Alloderm patients developed or bulging at the repair site. Post-operative bulging and hernia recurrence was a major problem with the AlloDerm mesh. Further design improvements are required for these new mesh products. Surgeons should be aware of these potential complications prior to the selection of products and the patient should be informed and educated accordingly. Even with these known AlloDerm problems, the FDA has not recalled AlloDerm nor has it sent out any warning communications. The FDA remains in a let’s wait and see mode.Copyright © 2012 All rights reserved. Anapol Schwartz, PRead more information online at www.anapolschwartz.com. .C. AlloDerm ||
    • Attention Hernia Repair Patients: Recent reports published by the U.S. Food and Drug Administration warn against using surgical mesh such as AlloDerm because of potential complications. These include adverse reactions to the mesh, adhesions (when the patient’s intestinal loops adhere to the mesh or each other) and injuries to nearby organs, blood vessels or nerves. If you or someone you love has experienced complications with AlloDerm that was used to repair his or her hernia, you may be entitled to compensation Your chance of a successful claim increases dramatically when you choose experienced team for legal representation. The personal injury lawyers at Anapol Schwartz are known for their prosecution of products liability cases. Take steps to get reparations for hardships you are suffering due to any ongoing medical problems.If you are one of the unfortunate hernia repair patients with complications because of AlloDerm, get the help you need by calling Anapol Schwartz. Their skilled Pennsylvania personal injury lawyers will work closely with you to get the compensation you deserve. Protect yourself and your rights by consulting with our lawyers today.Copyright © 2012 All rights reserved. Anapol Schwartz, PRead more information online at www.anapolschwartz.com. .C. AlloDerm ||