Physiomesh Surgical Products: Complications and Lawsuits
Physiomesh is a type of surgical mesh used to repair abdominal hernias. The synthetic mesh is comprised of polypropylene and polydioxanone fibers that anchor to a poliglecaprone film. This film is supposed to keep the mesh separate from bodily tissues to prevent unintended attachment and absorption.
But some patients are reporting complications associated with the device, such as mesh migration and organ perforation, which may require revision surgeries to correct.
Abdominal hernias develop when the abdominal muscles or tissues weaken, allowing portions of the stomach or intestines to protrude through abdominal walls. Physiomesh is a synthetic material used as a tissue bridge to support and close abdominal walls in hernia repairs.
Ethicon, part of Johnson & Johnson, manufactures the product. The U.S. Food and Drug Administration (FDA) first approved it in April 2010 through a predicate device similarity, meaning the FDA approved the device based on its similarity to other devices, without requiring further clinical trials.
Physiomesh Side Effects
Most surgeons perform Physiomesh hernia repairs through a laparoscopic procedure, though some may require open abdominal surgery. Therefore, patients may experience side effects common with other surgical procedures and should first review these risks and potential complications with their surgeon.
Additionally, many Physiomesh patients have experienced other severe complications shortly after their initial surgery that required revision surgeries. Common severe adverse side effects with Physiomesh may include:
- Abnormal connection between organs (fistula)
- Fluid build-up at hernia site
- Hernia recurrence
- Intestinal blockage
- Perforation of the neighboring tissues or organs
- Scar tissue that sticks together (adhesion)
Patients should report any side effects or complications they experience after surgery to their doctor, even if they do not appear on this list.
High Incidence of Physiomesh Revision Surgeries
Since the device’s approval in April 2010, several patients and medical professionals have submitted complaints to the FDA regarding device failure that has necessitated revision surgery. Along with some of the complications listed above, mesh migration (when the mesh moves out of place) and mesh shrinkage (when the mesh becomes smaller) are two critical complications that may necessitate revision surgery.
Revision surgery is a secondary surgery that may be necessary if the Physiomesh causes severe complications. Doctors may use revision surgery to reposition the mesh after it migrates or replace the mesh entirely if it shrinks, perforates an organ or tissue, or causes a blockage.
One of the first complaints the FDA received came in November 2010 when a patient required a second laparoscopic surgery after experiencing severe pain and visible bulging. During the revision, the doctor discovered the Physiomesh became partially loose and frayed where the surgeon placed the tackers. The surgeon removed the mesh and used another hernia closure technique.
These revision surgeries cause more pain and suffering for patients who already went through one hernia repair surgery and then suffered serious complications from the Physiomesh.
Ethicon’s Voluntary Withdrawal of Physiomesh from the Market
Ethicon voluntarily withdrew its Physiomesh hernia repair product from the market in May 2016. This withdrawal came after several reports of significant complications and high rates of revision surgeries associated with the surgical product.
The recall included the following Physiomesh product codes:
Before withdrawing Physiomesh, Ethicon obtained marketing approval for Physiomesh Open, a revised version of the product. This device began marketing in June 2014 and once it gained market traction, Ethicon voluntarily withdrew the original Physiomesh product.
It is important to note that only the Ethicon Physiomesh product is the subject of defective device claims, and there have been no significant reports of complications from the Ethicon Physiomesh Open product at this time. However, many patients do not know what kind of surgical mesh their surgeon used in their hernia repair. Therefore, patients who experience complications should report them to their doctor, and then speak with a lawyer if they believe they may be suffering from a defective Physiomesh device.
Physiomesh is the subject of several lawsuits in U.S. federal court. The court may hear the first lawsuit in January 2018 in a case involving a patient who developed an infection. The patient developed two abdominal abscesses and an intestinal fistula. In addition to revision surgery to remove the mesh, the patient required surgery to debride the abscesses and repair the fistula.
Experts expect the lawsuits to grow as other patients who suffered injuries and complications associated with Physiomesh implants come forward. If successful, lawsuits against manufacturers of defective medical devices may recover compensation to cover:
- Medical expenses
- Lost wages and earning potential
- Physical and emotional pain and suffering
Other damages may be recoverable depending on the case and effects of the injury. Patients should review their case and recoverable damages with a lawyer to account for all compensation they may be entitled to recover.
Finding Help after Complications with Physiomesh Hernia Repair
Even though Ethicon recalled the defective Physiomesh products on a global scale, surgeons used these implants until early 2016. Some hernia patients did not experience the full extent of complications until years after the surgery.
If you underwent hernia repair with a mesh product and experienced any of the complications mentioned on this page, speak with a lawyer. A lawyer can investigate your case, identify which product the surgeon used in your hernia repair, consult medical experts about your condition, and evaluate whether you may have a valid claim against the manufacturer if the Physiomesh is to blame for your complications.
For help finding a lawyer who can help with your defective medical device case and explain your right to recover damages after a Physiomesh-related injury, call 1-800-DRUG-411.