On May 25, 2016, Ethicon, a subsidiary of Johnson & Johnson (J&J), released an urgent field safety notice alerting hospitals, surgeons, and medical center personnel worldwide to stop using their “Physiomesh,” a type of flexible composite mesh used in hernia repair procedures.
Ethicon explained that they were issuing a “voluntary product recall” because an analysis of data showed that recurrence and reoperation rates after laparoscopic hernia repair using Physiomesh were “higher than the average rates of the comparator set of meshes among patients.”
Meanwhile, a number of people who had hernia surgery with an Ethicon Physiomesh have filed lawsuits against the manufacturer, claiming that the mesh led to health problems including chronic pain, infection and the need for revision surgery. The plaintiffs, along with consumer watchdogs, claim Ethicon waited too long to pull their allegedly defective product off the market, and that they should have done so years ago when they first became aware of the risks. Instead, they continued to profit from it, leaving patients and their doctors in the dark as to the potentially dangerous side effects.
What is the Ethicon Physiomesh?
The FDA first approved the Ethicon Physiomesh on April 9, 2010. The company performed no clinical trials on the device to prove its safety and efficacy. Instead, they used the FDA’s fast-track 510(k) approval program, which requires only that the manufacturer proves their product is significantly similar to others on the market.
The product is a type of netting made of polypropylene materials and is designed to be used for the repair of ventral (abdominal) hernias. The device can be thought of as a “hernia patch,” a piece of netting that the surgeon uses to stabilize the weak and stretched tissues and muscles around a hernia bulge. The netting itself is made of non-absorbable plastic filaments and is laminated between two layers of Monocryl (poliglecaprone), a material that is supposed to help reduce the risk of inflammation and facilitate fast healing.
A hernia occurs when fatty tissue, an organ, or a part of an intestine squeezes through a hole or weak spot in the surrounding muscle or connective tissues. They’re commonly found in the abdomen, but may also show up in other areas, like the groin. Risk factors for hernias include being overweight, overexertion and smoking. Excess pressure in the abdomen, including pressure that occurs with diarrhea and constipation or persistent coughing and sneezing, can also increase risk.
Most hernias don’t cause any symptoms initially, but they may become visible as a “bulge” under the skin. Some people may experience discomfort and pain when moving in certain ways. If the hernia isn’t causing any immediate problems, doctors typically advise watchful waiting. But if it causes pain, or if it obstructs part of the intestine, it must be repaired.
There are two basic options for surgery: open surgery and laparoscopic surgery. In open surgery, the surgeon makes an incision near the hernia and repairs it using sutures and/or mesh, shoring up the weak muscles and tissues to reinforce the area and tucking the extended material back where it belongs.
A laparoscopic repair surgery is very similar, but the surgeon makes a smaller incision and uses a laparoscope with a camera on it to guide his work. This type of surgery is less invasive and usually results in a faster recovery.
Why Did Ethicon Recall the Physiomesh?
Ethicon recalled the hernia mesh after studies showed that it had higher revision rates after a laparoscopic repair than other types of mesh. They did not make a clear statement as to why the mesh didn’t perform as expected, and simply advised doctors and hospitals to remove the products from use and return them to Ethicon for reimbursement.
In a hazard alert released by Australia’s Therapeutic Goods Administration (TGA), authorities alerted consumers and healthcare providers to the recall, noting that an analysis from two large independent overseas hernia registries, in Germany and Denmark, showed Ethicon Physiomesh had a higher rate of recurrence compared to the rates of other similar products. They warned patients to watch out for symptoms of recurrence.
Ethicon advertised their product as being made of inert materials, but plaintiffs bringing Physiomesh claims argue that the material is incompatible with human tissue and promotes an immune response once it’s implanted. The immune system can attack the mesh, seeing it as a foreign invader, and create inflammation around the surgical repair area.
Ethicon promoted Physiomesh’s multi-layer coating as a means to prevent or minimize adhesion and inflammation. They added that it encouraged incorporation of the mesh into the body. But what’s actually happening is an inflammatory reaction that can damage surrounding tissues and lead to device migration, scar formation, and improper healing. The coating on the product has also been blamed for preventing fluid escape, which can lead to the formation of pockets of swelling (seromas). These, in turn, can lead to abscess formation and infections.
Worse, if the outer layer is disrupted or degrades, the mesh itself can come into contact with the surrounding tissues and may adhere incorrectly, causing additional damage.
Studies Show Physiomesh Linked to Complications
In addition to patient complaints, a number of studies have linked hernia mesh with serious complications. In a recent study published in the journal Surgical Endoscopy, researchers compared two different types of mesh used for hernia repair: Physiomesh and Ventralight ST mesh.
They originally planned to study 50 patients in each group but ended up stopping the study prematurely for safety reasons. They observed 5 hernia recurrences in the Physiomesh group (20 percent) in the first six months compared to none in the Ventralight group. They also observed a significantly higher pain rate in the Physiomesh grouncbi.nlm.nih.gov/pubmed/24398196p after three months. They concluded that the results showed Physiomesh was associated with “significantly greater hernia recurrences and postoperative pain” compared with the Ventralight group.
In another recent study, researchers compared three types of mesh, including Physiomesh and Ventralight, and found that Physiomesh caused more seromas (pockets of fluid) than the other two products did, and was less effective at integrating itself into the surrounding tissues.
In another study, researchers again compared Physiomesh with Ventralight, and found that both contracted about the same percentage, but that Physiomesh created more inflammation and scar tissue. They concluded that Ventralight exhibited more favorable characteristics than Physiomesh when observed over a 14-day implantation period.
Plaintiffs who have filed lawsuits against Ethicon note that the material in their hernia mesh is the same that the company uses in their controversial transvaginal mesh, which is now the subject of thousands of lawsuits and has been connected with migration, puncture and perforation of organs, infections and excruciating pain.
Types of Injuries Associated with Ethicon Physiomesh
Patients who have been implanted with a Physiomesh and then experienced problems have reported injuries including the following:
- Swelling and redness
- Internal scar tissue
- Mesh migration
- Mesh shrinkage
- Mesh distortion
- Organ damage
- Nerve damage
- Recurring hernia
- Required revision surgery
- Seromas (fluid build-up)
Ethicon Physiomesh Lawsuits
Plaintiffs claim that Ethicon, the Physiomesh manufacturer knew about the problems associated with its product, yet failed to provide adequate risk warnings on the labeling and related product materials. They also claim the company failed to adequately test the product before and after it was introduced on the market.
The number of lawsuits concerning Physiomesh continues to increase. A group of plaintiffs filed a motion to centralize all federally-filed cases into a multidistrict litigation (MDL). They requested the cases be transferred to the Middle District of Florida. Arguments for centralization were heard before the Judicial Panel on
Multidistrict Litigation (JPML) at the end of May and decision is pending.
Meanwhile, patients who were implanted with Physiomesh and experienced complications may be eligible to file a Physiomesh lawsuit. Chaffin Luhana is now investigating these cases and invites you to call today at 1-888-316-2311.