Johnson & Johnson’s Ethicon division is facing several lawsuits filed by patients who suffered complications from the company’s Physiomesh hernia mesh patch. Ethicon withdrew Physiomesh from the market in May 2016 after research suggested that it was associated with a high rate of complications in patients who undergo hernia surgery with the device.
Patient who have suffered complication from Physiomesh – including bowel obstruction, infection, hernia recurrence, or mesh failure – may be eligible to file a lawsuit and seek compensation for their injuries.
What is Physiomesh?
Physiomesh is a surgical mesh patch made from polypropylene, the same material used in Ethicon’s transvaginal mesh and bladder slings. The Physiomesh patch is manufactured with two different absorbable film coatings on either side of the device in order to prevent tissue damage that may be caused when the polypropylene mesh comes into direct contact with the body.
The Physiomesh patch was approved under the FDA’s controversial FDA 510(k) approval process, in which medical devices can be approved without rigorous pre-market research and studies if they are deemed to be “substantially similar” to medical devices already on the market. In the case of Physiomesh, Ethicon claimed that the device was similar to the Proceed hernia patch, which is also sold by the company. Ethicon also received FDA approval for a modified version of the Physiomesh patch in October 2014.
Design Defects Associated with Physiomesh
Lawsuits filed against Ethicon have alleged that the Physiomesh hernia patch is defectively designed due to problems with the coatings on both sides of the device.
Because polypropylene – the material used to manufacture Physiomesh – can stick to tissue that it comes into contact with inside the body, Ethicon added a thick coating to both sides of the mesh patch. Although this coating helps to prevent tissue damage from direct contact between the bowels and the polypropylene in the Physiomesh patch, it can also prevent the device from being properly incorporate into the abdominal wall after surgery. This can lead Physiomesh to migrate within the patient’s body, increasing the risk of complications.
Physiomesh is also manufactured using polypropylene that is more lightweight that other mesh devices sold by Ethicon. Although this light weight polypropylene was intended to reduce the risk of complications from Physiomesh, it may also increase the risk that the mesh may tear inside the body, which may produce serious health complications.
Physiomesh Withdrawn Due to Increased Risk of Complications
In May 2016, Ethicon withdrew Physiomesh after research showed that patients who underwent hernia repair surgery with the device were more likely to undergo revision surgery. In a letter sent by Ethicon to health care providers, the company stated that European researchers had found that patients who underwent laparoscopic ventral hernia repair surgery using Physiomesh underwent additional hernia surgeries more often than patients who were treated with another mesh patch.
Patients who undergo hernia repair surgery with Physiomesh may be at risk of serious complications from the mesh patch. In addition to the increased risk of revision surgery, researchers have also found that patients treated with Physiomesh may experience obstructed bowels, fluid buildup under the skin (seromas), infections, or mesh failure.
Due to risks that Physiomesh may tear or be poorly incorporated into the body, patients have experienced a higher rate of hernia recurrence compared with other mesh products. Patients who experience hernia recurrence or other complications from Physiomesh may be forced to undergo additional surgery in order to treat problems caused by the device.
Physiomesh Lawsuits Filed Against Ethicon
Ethicon is facing several lawsuits in federal court filed by patients who experienced complications from Physiomesh hernia mesh. These lawsuits have alleged that Physiomesh was defectively designed, causing a high rate of complications and revision surgeries. The lawsuits also allege that Ethicon delayed in withdrawing Physiomesh from the market after receiving reports of complications with the device in order to allow another mesh device sold by the company to gain traction in the market.
According to these allegations, Ethicon received multiple reports that associated Physiomesh with an increased risk of complications, including a higher-than-expected rate of revision surgery for patients treated with the device. The company submitted a new version of the patch, known as Physiomesh Open, to the FDA in June 2014 and received approval under the 510(k) review process in October of that year. However, Ethicon alleged waited until May 2016 – 14 months after Physiomesh Open had been approved by the FDA – to withdraw the original Physiomesh device from the market in order to allow Physiomesh Open to gain market traction.
In addition to the lawsuits filed by Physiomesh patients, Ethicon is also facing thousands of lawsuits filed on behalf of women who suffered complications from transvaginal mesh products manufactured by the company. Transvaginal mesh – which are surgical mesh products used to treat stress urinary incontinence or pelvic organ prolapse – are made from the same polypropylene material used in Physiomesh.
Complications from Physiomesh? You May Qualify to File a Lawsuit.
Patients who have undergone revisions surgery or experienced other complications after being treated with a Physiomesh patch may be eligible to file a lawsuit. The first step in taking legal action is to speak with an experienced medical device litigation attorney who can advise you regarding your rights and guide you through the initial steps of filing a case.
The lawyers at Heygood, Orr & Pearson have represented hundreds of individuals who were injured by surgical mesh products or other dangerous medical devices. Our firm has considerable experience and expertise when it comes to pursuing claims against the drug and medical device industry, and has achieved verdicts and settlements on behalf of our clients totaling hundreds of millions of dollars. Our attorneys have made it a career priority to hold drug and medical device manufacturers accountable and responsible for the injuries caused by their products.
For more information about the Physiomesh lawsuits against Ethicon and to find out whether you may qualify to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form and answering a few brief questions to get started.