May 2016 Market Withdraw for Ethicon Physiomesh:
Recall Lawsuits Reviewed Nationwide
Due to a high rate of problems with Ethicon Physiomesh Flexible Composite Mesh, a “Market Withdrawal” was issued for certain versions of the hernia surgery mesh, recalling the products from the market worldwide.
In an Urgent Field Safety Notice (PDF) issued in May 2016, Johnson & Johnson’s Ethicon subsidiary encouraged operating room supervisors, materials management personal and surgeons not to use certain Ethicon Physiomesh hernia patch products, which have been linked to reports of:
- Abdominal Pain, Infection and Other Complications
- Hernia Recurrence
- Adhesions, Perforations, Erosion or Failure
- Revision Surgery to Remove Ethicon Physiomesh
The lawyers at Saiontz & Kirk, P.A. are reviewing potential Ethicon Physiomesh recall lawsuits for individuals who had this unreasonably dangerous and defective hernia repair mesh surgically implanted in their body.
It is not necessary to know what specific type of hernia mesh was used during surgery before contacting our law firm.
Free consultations are provided to help individuals and families determine whether financial compensation or settlement benefits may be available as a result of complications from recalled Ethicon Physiomesh products. Request a free case evaluation.
Ethicon Physiomesh Removal from Market
Ethicon introduced Physiomesh in 2010, as a polypyrene mesh was intended to repair hernias and other fascial deficiencies. A number of different types of Ethicon Physiomesh Flexible Composite Mesh were marketed and sold for use during hernia surgery throughout the United States. However, it now appears the products were defectively designed or manufactured, posing an unreasonable risk of severe injury.
While the manufacturer claimed that the hernia mesh underwent comprehensive bench and animal testing, it was introduced through the agency’s controversial 510k fast-track approval process, which required minimal testing to establish that the Physiomesh was safe and effective.
Following several years of real-world data involving problems with Ethicon Physiomesh, a recall was issued in several countries on May 25, 2016, and the action was classified as a “Market Withdrawal” in the United States.
Ethicon Physiomesh was removed from the market after an analysis of unpublished data from two large independent hernia repair registries, including the Herniamed German Registry and Danish Hernia Database-DHDB. However, consumers were never properly notified that their hernia mesh was recalled.
Recurrence or hernia reoperation rates after laparoscopic ventral hernia report using Ethicon Physiomesh Composite Mesh were noticeably higher than the average rates of hernia mesh problems involving other products.
The manufacturer was unable to fully determine the cause of the complications with Ethicon Physiomesh.
- Ethicon Physiomesh Flexible Composite Mesh PHY0715R – Rectangle 7.5cm x 15cm
- Ethicon Physiomesh Flexible Composite Mesh PHY1015V – Oval 10cm x 15cm
- Ethicon Physiomesh Flexible Composite Mesh PHY1515Q – Square 15cm x 15cm
- Ethicon Physiomesh Flexible Composite Mesh PHY1520R – Rectangle 15cm x 20cm
- Ethicon Physiomesh Flexible Composite Mesh PHY1520V – Oval 15cm x 20cm
- Ethicon Physiomesh Flexible Composite Mesh PHY2025V – Oval 20cm x 25cm
- Ethicon Physiomesh Flexible Composite Mesh PHY2030R – Rectangle 20cm x 30cm
- Ethicon Physiomesh Flexible Composite Mesh PHY2535V – Oval 25cm x 35cm
- Ethicon Physiomesh Flexible Composite Mesh PHY3035R – Rectangle 30cm x 35cm
- Ethicon Physiomesh Flexible Composite Mesh PHY3050R – Rectangle 30cm x 50cm
It appears likely that the manufacturer knew or should have known about the risks associated with these products long before they were removed from the market, and placed their desire for profits before consumer safety by failing to promptly issue an Ethicon Physiomesh recall in a timely manner.
Free Ethicon Physiomesh Recall Lawsuit Evaluation
The hernia mesh lawyers at Saiontz & Kirk, P.A. have represented individuals nationwide who have experienced complications from dangerous and defective hernia repair products, including Atrium C-Qur mesh, Alloderm mesh and recalled Kugel mesh.
Free consultations and claim evaluations are provided to help individuals and families determine whether they may be entitled to financial compensation through an Ethicon Physiomesh recall class action, or individual injury claim for those who have suffered problems resulting in the need for revision surgery.
Since most individuals are unaware of the specific hernia repair product used during their surgery, and are often not told that about a hernia mesh recall. In fact, doctors have been instructed to treat individuals with recalled Ethicon Physiomesh products in the usual manner, and few, if any, have specifically been informed that they have a defective product implanted in their body.
After speaking with our law firm for a free Ethicon Physiomesh case evaluation, there is no obligation to hire our lawyers or pursue a case. If it is determined that you or your family may be entitled to join the litigation over Physiomesh injuries, it remains your decision whether to form an attorney-client relationship and move forward with a case.
All cases are handled by our lawyers under a contingency fee agreement, which means that there are never any out-of-pocket costs to pursue a case, and we only receive an attorney fee or reimbursement of expenses if we are successful obtaining an Ethicon Physiomesh recall settlement or another recovery for you and your family.