Ethicon Physiomesh Removed from the Market Due to Complications
Ethicon Physiomesh Removed from the Market
Due to Complications
On May 25th, 2016, Ethicon, a subsidiary of Johnson & Johnson, recalled their popular Physiomesh Flexible Composite hernia mesh due to two large independent registry studies (HerniaMed German Registry and Danish Hernia Database) that demonstrated higher complication rates resulting in significant injuries.
Synthetic hernia meshes such as Physiomesh are used for the repair of ventral or abdominal hernias. These meshes help strengthen the abdominal or pelvic wall to prevent worsening or recurrence of existing hernias. Unfortunately, some patients may have experienced defects with a prior hernia mesh such as AlloDerm or Kugel Mesh and had Physiomesh implanted for those subsequent repairs.
Physiomesh was used from 2010 to 2016
If you or a loved-one had a hernia mesh surgery between 2010 and 2016, you may have had a Physiomesh implanted. Your doctor may not have informed you of this recall and if you had a hernia mesh implanted during this time, you owe it to yourself to find out if you’re at risk for future complications.
What are the possible complications associated with Physiomesh?
- Hernia Recurrence
- Additional Hernia Revision Surgery
- Damage to Intestines and Other Internal Organs
- Seromas or Incomplete Healing of Hernia Repair
- Abscess Formation and Infections
- Adhesion Formation or Scarring
What if I haven’t suffered any complications with Physiomesh?
Even if you or a loved-one has not yet suffered any complications from a Physiomesh, you may be at future risk for developing them. You may still be eligible for future compensation.
Why did Physiomesh result in so many injuries?
- It is believed the materials and coatings used in Physiomesh inhibited its ability to safely incorporate into the body. This has resulted in higher rates of recurrence and injury.
- Ethicon chose to use the less stringent FDA 510(k) clearance process instead of using the more rigorous FDA pre-market approval process to ensure the safety and effectiveness of Physiomesh. A full pre-market approval process would have required clinical trials which could have uncovered safety issues before mass marketing and worldwide use.
What should I do next?
If you or a loved-one had a hernia mesh surgery between 2010 and 2016 and think you may have had a Physiomesh, call our experienced team of lawyers and professionals for a free consultation. Even if you are not sure what type of mesh that you or loved one had but any of the complications described above occurred, contact us so that we can investigate your case. We at Potts Law Firm are at the national forefront of mesh litigation and accept cases from all 50 states. For the health and safety, as well as piece of mind, contact Potts Law Firm for a free consultation at 888-902-6245.