Physiomesh Recalled Due to High Failure Rates
Ethicon, a Johnson & Johnson unit, is recalling its Physiomesh because studies show that patients are undergoing higher rates of revision surgery compared to other mesh devices. Physiomesh flexible composite hernia mesh is used for minimally invasive abdominal and groin hernia repair.
In a May 25, 2016 “Urgent Field Safety Notice” Ethicon told healthcare providers that its Ethicon Physiomesh Composite Mesh is being recalled. The letter cited unpublished data from two large independent hernia registries showing that patients undergoing laparoscopic (minimally invasive) ventral hernia repair with Ethicon Physiomesh Flexible Composite Mesh had higher recurrence/reoperation rates compared to the average rates of comparator set of meshes. The data was based on one Danish hernia registry and one German registry.
Ethicon says the higher rates of revision associated with its Physiomesh hernia are based on several different factors. The company writes, “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.”
The company is currently unable to pinpoint a cause for the high recurrence rates, and therefore cannot give recommendations that might reduce the risk of revision. “Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” the letter states.
“Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”
This is not the first time Ethicon has faced safety issues regarding its mesh products. The company has also faced substantial litigation involving its transvaginal mesh products, which are used to support sagging pelvic organs and treat incontinence. Parker Waichman LLP transvaginal mesh attorneys comment that transvaginal mesh and slings use polypropylene, the same material in the base layer of Physiomesh.
Transvaginal Mesh Lawsuit Update: Ethicon Agrees to $120M Vaginal Mesh Settlement
In January, Johnson & Johnson agreed to pay over $120 million to settle 2,000 to 3,000 transvaginal mesh lawsuits alleging the pelvic mesh devices caused pain, organ damage and other injuries. A regulatory filing showed the company still faces another 42,000 pelvic mesh lawsuits. The vaginal mesh settlement is the first time J&J has agreed to resolve a large number of transvaginal mesh lawsuits.
Many device makers are being sued over vaginal mesh inserts, which are approved to treat stress urinary incontinence and pelvic organ prolapse. The largest number of lawsuits, however, have been filed against J&J’s Ethicon unit. Vaginal mesh lawsuits began in 2011; now, at least 100,000 lawsuits have been filed against manufacturers such as J&J, C.R. Bard and Boston Scientific.
Plaintiffs in the transvaginal mesh lawsuits have similar claims, alleging that the mesh is defective and led to injuries such as mesh erosion, where the mesh became embedded in the tissues of the body, causing severe pain and organ damage. Many plaintiffs allege undergoing multiple surgeries to remove the mesh, often successfully.
Transvaginal Mesh Lawsuit Background
Transvaginal mesh lawsuits allege that device makers such as Ethicon failed to properly test their products before they were sold and implanted in thousands of women. This is because the devices were approved through 510(k), which allows devices onto the market without clinical testing. Manufacturers gaining approval through this route need only show that it is “substantially equivalent” to a previously approved device. This fast-track route is not intended for high-risk devices.
Pelvic mesh litigation and safety concerns have increased scrutiny over 510(k) and the devices that obtain approval through this route. Critics, patient advocates and experts have argued that transvaginal mesh should not have been approved through 510(k). In response, the FDA has since reclassified pelvic mesh as “high-risk”, meaning now they can only be approved with clinical testing for safety and efficacy.
Parker Waichman notes that Physiomesh was approved through 510(k) in October 2014.
In 2011, the FDA released a safety alert warning the public that complications associated with transvaginal mesh implants were “not rare”. This is contrary to what the agency communicated in 2008. The updated notification further states that transvaginal mesh inserts do not have clear benefits for patients with pelvic organ prolapse compared to non-mesh methods, and may pose more risks. In 2008, the FDA said the most common complications with transvaginal mesh were:
- Mesh erosion
- Urinary problems
- Recurrence of prolapse
Women also reported that the mesh perforated their bowels, bladder and blood vessels when the device was inserted.
Physiomesh or Transvaginal Lawsuit Questions?
If you or someone you know suffered injuries related to the use of Johnson & Johnson’s Physiomesh for hernia repairs or transvaginal mesh implants, you may have valuable legal rights. Parker Waichman’s transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).