AlloDerm was once thought to be a revolutionary product capable of being used in a wide variety of applications including the treatment of severe lacerations, breast reconstruction, and hernia repair. For many years, AlloDerm was considered safe. Today, however, mounting evidence and numerous case studies prove otherwise. AlloDerm has been associated with a number of extremely serious side effects including organ, nerve and blood vessel damage.
Free AlloDerm Lawsuit Case Evaluation: If you or a loved one has been injured by a defective AlloDerm product, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
AlloDerm is a genetic mesh made of donated human skin which is designed to encourage cell and tissue regeneration. Before being used on a patient, cells are carefully removed from the cadaver dermis to prevent rejection by the recipient and to promote rapid revascularization. This removes all cells from the donor tissue, leaving only the collagen framework for use in surgical procedures. Because of this purification process, LifeCell claims that the chances of a recipient experiencing an allergic reaction or rejection with AlloDerm are much lower than with non-biological mesh materials.
For the most part, AlloDerm is used for hernia repairs and breast reconstruction following mastectomies. However, it has a wide variety of other applications including dental work, hernia repairs, as well as in the treatment of severe burns and lacerations. Classified by the FDA as a ‘banked human tissue,’ the AlloDerm Regenerative Tissue Matrix uses human cells to:
- develop blood vessels
- attract white blood cells
- allow the graft to eventually become part of the host tissue
- minimize the chances of graft failure or rejection
Which Side Effects Have Been Linked to AlloDerm?
Complications associated with AlloDerm products include (but are not limited to):
- Development of abscesses
- Infection, which can become life-threatening
- Hernia relapse
- Seroma (pockets of serous fluid)
- Graft explant
- Tearing of the mesh patch
- Defective patches
- Perforations in the product causing tissue weakness
- Injury to organs, blood vessels, and other tissues that are close to the patched area
- Splitting open of an organ or tissue (dehiscence)
- Disease transmission from the graft
- Adhesion failure
- Failure of proper healing of surgical incisions
- Mesh erosion
- Post-operative bulging
- Extreme discomfort
- Allergic reaction
Hernia recurrence may be the single most commonly reported side effect associated with AlloDerm. In an article published by MedSun (an adverse event reporting program launched by the FDA’s Center for Devices and Radiological Health), the administration warns about complications that can occur when AlloDerm is used for hernia repair. Commonly reported complications cited by the article included injuries to nearby organs, nerves and blood vessels, as well as adverse reactions to the mesh and adhesions (where the loops of a patient’s intestine adhere to the mesh or each other).
Additional studies of patients who had AlloDerm implanted to repair an abnormal hernia had the shortest follow-up period and the highest overall failure rate compared to patients treated with other hernia repair products. The medical literature seems to show an apparent lack of long-term or follow-up studies on patients who had AlloDerm to repair a hernia. Many believe that more extensive research is needed as AlloDerm graft stretching may occur over time. Companies involved in the reporting of AlloDerm hernia repair problems include:
- Covidien United States Surgical Corporation
- Davol Inc. A subdivision of C.R. Bard, Inc.
- Lifecell Corp.
- Ethicon Inc.
- Tissue Science Laboratory
- Bard Urology Department
- Bard Access Systems
AlloDerm Lawsuit Consolidation
In June 2011, a request was made to consolidate all AlloDerm lawsuits filed in New Jersey state court. At least 25 cases have been filed throughout the state, and many more are expected in the near future. The claims allege that LifeCell designed a defective product and failed to warn the public about the risk of AlloDerm side effects. According to the complaints, plaintiffs have suffered from a number of serious injuries including hernia mesh problems, infections, abscesses, bruising, swelling, and recurrence of other problems that have required revision surgeries to correct.
A mass tort designation in New Jersey would centralize all cases filed in the state court system before one judge for pretrial proceedings to avoid duplicate discovery and contradictory rulings. Despite being consolidated into a single court, the claims would remain individual lawsuits that will be judged independently at trial. Plaintiffs have requested that the pretrial consolidation be overseen by Judge Carol E. Higbee in Atlantic County, where 11 of the claims have already been filed.
Injured by AlloDerm Side Effects? Contact Us Today.
If you or a loved one was injured by an AlloDerm patch, it’s important to contact a lawyer who can help protect your rights. At Schmidt & Clark, LLP, our personal injury attorneys can help with all aspects concerning your AlloDerm lawsuit. Whether it was a botched skin graft or defective hernia patch, we can help get you the compensation you deserve. Initial consultations are free, and our experienced attorneys will never charge you any legal fees unless a favorable settlement is awarded.
Do You Have an AlloDerm Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in AlloDerm lawsuits. We are handling individual litigation nationwide and currently accepting new AlloDerm injury cases in all 50 states.