Physiomesh – Emerging Litigation

Introduction:

Physiomesh involves Ethicon, a subsidiary of Johnson & Johnson. The PHYSIOMESH is made from polypropylene and is intended for hernia repair. Ethicon has been battling lawsuits for years against its transvaginal mesh products, which are also made from polypropylene include organ perforation, mesh migration, sepsis and death. However, Ethicon issued a market withdrawal on the PHYSIOMESH in May of 2016.

Ethicon continues to deny the life-threatening complications that polypropylene causes. However, Ethicon issued a market withdrawal on the PHYSIOMESH in May of 2016

Ethicon maintains the stance that they merely voluntarily withdrew the PHYSIOMESH from the US market in May of 2016. Ethicon “voluntarily withdrew” the PHYSIOMESH after independent studies revealed high rates of complications associated with the PHYSIOMESH. The previous high rates of patient and surgeon complaints were never enough to sway Ethicon into removing the PHYSIOMESH from the market.

FDA Alerts

In May 2016, Ethicon recalled all unused stock of Physiomesh in Europe and Australia, but only issued a “market withdrawal” in the united states.

In September 2016, a lawsuit was filed by a woman from Florida who was seriously injured by Ethicon Physiomesh. She says it blocked her intestines, caused chronic pain, and could not be completely removed because it was embedded in her abdominal wall

In April 2016, a lawsuit  was filed by a man from Illinois who was implanted with Physiomesh in 2013. In July 2015, he developed symptoms of an infection and was diagnosed with two abscesses and an intestinal fistula. His case is set for trial in January 2018 before Judge J. Phil Gilbert

Two large studies in Germany and Denmark found higher rates of hernia recurrence and re-operation in patients with Physiomesh compared to similar products. Ethicon said the problem was “multi-factorial issue.” Because they could not tell surgeons how to fix the problem, Ethicon decided to stop selling Physiomesh.

Urgent: Field Safety Notice (Issued from Ethicon)

ETHICON PHYSIOMESH™ Flexible Composite Mesh

(All Product Codes)

Ethicon has initiated a voluntary product recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh (for laparoscopic use) (“ETHICON PHYSIOMESH™ Composite Mesh”). Ethicon is recalling the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia Database – DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH ™ Composite Mesh were higher than the average rate s of the comparator set of meshes among patients in these registries.

Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors. Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to re call ETHICON PHYSIOMESH ™ Composite Mesh from the global market.

Health care practitioners that have treated patients using ETHICON PHYSIOMESH ™ Composite Mesh should continue to follow those patients in the usual manner.

This voluntary recall has been communicated to the U.S. Food and Drug Administration (FDA) and the European Competent Authorities.

This action involves only the ETHICON PHYSIOMESH™ Composite Mesh product line. It does not include the ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device, or other hernia mesh or device products manufactured or sold by Ethicon.

The scope of this action includes all unexpired product codes of ETHICON PHYSIOMESH™ Composite Mesh and all unexpired procedure packs containing this product

Do not use or Distribute any of the following product codes

Product NameProduct CodeDescriptionSize
ETHICON PHYSIOMESH™ Flexible composite meshPHY0715RRectangle7cm x 15cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY1015VOval10cm x 15cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY1515QSquare15cm x 15cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY1520RRectangle15cm x 20cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY1520VOval15cm x 20cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY2025VOval20cm x 25cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY2030RRectangle20cm x 30cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY2535VOval25cm x 35cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY3035RRectangle30cm x 35cm
ETHICON PHYSIOMESH™ Flexible composite meshPHY3050RRectangle30cm x 50cm

 

Do not use or Distribute any of the following Procedure Packs

Product NameProcedure pack Product codeEthicon Physiomesh Product code
Laparoscopic Hernia PackELH5PHY1515Q
Laparoscopic Hernia PackELH10PHY1515Q


Case Evaluation Criteria

Patient Information:

  • Was the mesh actually placed?
  • Indication for mesh placement? Was it required? Any alternatives offered to patient?
  • Was he/she a right candidate for mesh placement?
  • Was mesh placement the patient’s choice?
  • Did the patient have any contraindication for the mesh placement?
  • Was there other associated risk factors/medical conditions for failure of the mesh?
  • Any prior mesh related surgeries, medical issues from history? Surgical history – Especially anything related to abdomen

Implant specific details:

  • Type of hernia repair (ventral/incisional/umbilical)
  • How the hernia mesh was secured (interrupted sutures, tacks, stables)
  • Type of procedure (open/laparoscopic)

Product details – Sample:

Product nameE.g.: Ethicon Physiomesh Flexible Composite Mesh
Manufacturer’s nameE.g.: Ethicon
Lot numberE.g.: PHY3050R
Size E.g.: 30 cm x 50 cm
Snapshot of the Product labelE.g.:

1

 

Operative note:

  • Detailed operative procedure for the placement/explant:

 

PhysioMesh sample picture:

2

 Complications/injuries due to the implanted mesh:

  • Abdominal pain or complications
  • Unexplained or persistent abdominal pain
  • Hernia recurrence
  • Scar-like tissue that sticks tissues together (adhesion)
  • Fever
  • Constipation
  • Diarrhea and/or vomiting
  • Tenderness at the surgery site or other unusual symptoms
  • Bowel obstruction / organ perforations
  • Mesh migration
  • Mesh Shrinkage (Contraction)
  • Chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
  • Sepsis
  • Death

Diagnosis and management of the post-operative complication to examine:

  • Whether the above mentioned symptoms were identified as a complication of mesh placement?
  • Any documentation that the doctor knew the mesh was recalled
  • Was it managed medically or surgically?
  • Did the patient undergo revision surgery for the failed mesh?
  • If surgically, whether the mesh was removed?
  • If mesh was removed or explanted, then the
  • Operative findings for the explant procedure
  • Appearance of the mesh upon removal (Folded over, wrinkled, balled-up, etc.)
  • Whether the patch had migrated, separated from the abdominal wall, broken, come apart, etc.
  • Pathology report of the explanted mesh
  • Pictures taken, explant retained for legal purposes, explant retained per patient, etc.

Condition of patient post mesh-explant:

  • Medical status of the patient?
  • Was the mesh replaced?
  • Has the primary diagnosis for which the mesh was indicated resolved?
  • What were the post operative complications encountered due to the revision surgery?

Critical Records Needed:

  • Product details
  • Operative notes
  • Post-operative stay
  • Follow-up visits stating the condition of the patient post mesh placement
  • Missing records have to be identified and confirmed with MD Specialist and should be communicated to the client