Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries.

One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or removal surgeries, the Physiomesh has been discovered to have shrunk, folded, or curled. Surgeons have found scar tissue surrounding the mesh. This scar tissue can cause severe pain and discomfort. In many cases, by the time the mesh is removed, the damage has been done and long-term problems remain.

What Is Hernia Mesh?

A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it does not belong. Depending on how bad the hernia is, surgery may be required to fix it. Because hernias involve a hole in a muscle or other tissue, additional reinforcement is thought to be needed to close the opening and keep it from reopening. This is where hernia mesh comes in. The mesh often takes the form of a plug or sheet of biological or synthetic mesh and is surgically implanted over the hole.

But not all hernia mesh is effective. And some don’t work.

Some Key Facts About Physiomesh

Physiomesh is a multi-layer mesh with layers of polypropylene and film. Ethicon hoped that the film layers would resist adhesions (scarring), permit mesh ingrowth into the abdominal wall, and maintain separation between the mesh and internal organs.

Physiomesh is a product intended to be used in laparoscopic surgeries. This is the less-invasive surgical technique using fiber-optic instruments and tubes. A laparoscopic surgical procedure is illustrated in the photograph to the left. In hernia repair operations, the tubes enter the abdominal wall and, using small cameras and other medical instruments, the surgeon is able to repair the hernia surgically, including in some cases implanting hernia mesh. Obviously laparoscopic procedures are less traumatic to the patient and easier from which to recover. That is, if the implanted devices are not defective.

Unfortunately, Physiomesh has been shown to cause scarring around the mesh, inflammation, implant folding and curling, and other serious complications. Physiomesh causes adhesions but does not permit adequate ingrowth into the abdominal wall.

Sadly, these results would have been available to Ethicon if it had done adequate premarket testing on the Physiomesh instead of rushing it to the market.

In April 2010 Physiomesh was approved to treat hernias in patients. It was approved by the FDA through the 510(k) process, which I have written about often on this site. The 510(k) process is a way around the more complex (and safer) premarket approval process. Under 510(k), the manufacturer notifies the FDA of its intent to market a device like hernia mesh and explains the device’s “substantial equivalence” to a device already on the market. The FDA may then approve the medical device for sale in the United States without extensive premarket testing. This is how Physiomesh made it to the market, in October 2010.

Physiomesh was on the market from October 2010 until the product was withdrawn in May 2016. This means that if you had surgery for hernia mesh repair between October 2010 and May 2016, and mesh was implanted, it could possibly be Ethicon’s Physiomesh.

Want to Learn More About Physiomesh?

There are studies you can access online which drills down on the subject of hernia meshes and the causes of hernia mesh failure:

Long-term evaluation of adhesion formation and foreign body response to three new meshes. Authors: Vogels RR, van Barneveld KW, Bosmans JW, Beets G, Gijbels MJ, Schreinemacher MH, Bouvy ND. Published in Surgical Endoscopy, 2015 August 29 (8):2251-9. Among other findings, this study concluded that “[f]ractioning of the Physiomesh(®) coating over time led to an increase in interfilamentary granuloma formation, leading to scar plate formation, but with only minimal to no abdominal wall adherence” and that Physiomesh is not “superior in all aspects required for effective and safe incisional hernia repair.”

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. Authors: Pawlak M, Hilgers RD, Bury K, Lehmann A, Owczuk R, Smietananski M. Published in Surgical Endoscopy, 2016 Mar 30 (3):1188-97. This study was stopped due to safety reasons, which is alarming. Conclusion: ” . . . the obtained results from the enrolled patients indicate that the [Physiomesh] system associated with significantly greater hernia recurrences and postoperative pain compared with the [Ventralight ST/SorbaFix] system.”

There are other studies out there, and plenty of other information on Physiomesh and the problems it has caused.

So What’s Next?

One estimate indicates that as many as 160,000 patients received the Physiomesh hernia mesh in the United States between October 2010 and May 2016. It is expected that hundreds of people will eventually file suit against Ethicon for injuries caused by Physiomesh.

On May 25, 2017, the Judicial Panel on Multidistrict Litigation (JPML) conducted a hearing on a motion brought by Physiomesh plaintiffs, who asked the JPML to create a new multidistrict litigation specifically for Physiomesh cases. I will let you know when a decision has been reached on that motion, though I suspect we will see a Physiomesh MDL.

In the meantime, if you have had any surgical mesh implanted in your body to treat a hernia, and particularly if you know you received a Physiomesh hernia repair product, you should speak with your doctor as soon as possible. This is important, even if you aren’t aware of any problems with the mesh. You may be fine, but you should monitor your situation carefully.

This is the safe and correct call. If you are diagnosed with melanoma, you need to focus on getting back to health. I suggest you stop taking the drug and schedule an immediate appointment with your dermatologist. In fact, I would say that even without a diagnosis of any skin cancer, you should ask your doctor (or a second doctor) if you should stop taking Viagra (or Cialis or Levitra). If a doctor you trust reviews your patient history and encourages you to remain on Viagra, fine.

2. Get Healthy

See your dermatologist or personal physician immediately. This is the most important thing to do if you are diagnosed with melanoma. Melanoma is the most serious of the skin cancers, and can certainly cause death is untreated or if treatment is delayed. Your health comes first. So move briskly to have the cancer removed. And of course stay out of the sun until you speak at length with your doctor.

3. Read the Studies

The starting point should be the post I wrote recently about the latest study identifying a possible connection between the use of Viagra (and Cialis and Levitra) and the onset of melanoma. This study is peer-reviewed and appears scientifically reliable. From my site you can click through to the study itself, or here. Read it carefully. Discuss the study’s findings with your dermatologist. In fact, discuss the findings with as many medical professionals as you have access to.

After reviewing the recent Sildenafil Study, do some additional research on the Internet. Many websites are well-researched, well-meaning, and helpful. But not all of them. I can’t stress this enough: The Internet is a freaky place. I once saw a funny cartoon depicting a doctor handing a prescription to a patient with the caption, “take two of these before you Google your symptoms.” Indeed, within a matter of minutes on the Internet you can be reading about the worst possible outcomes from taking a medication. Also, most people understand this but there is no requirement for truth on the Internet. People can write anything. (Of course, this rule applies to this website and to me too.) If something sounds unbelievable on a website, it is likely false. So again, be cautious and skeptical when conducting research on the Internet. The goal is to find reliable, helpful information, not the most sensational or terrifying.

4. Keep a Melanoma Journal

If you’ve read my posts in the past, you know I’m a big advocate of keeping detailed notes on your physical condition after any injury, whether that involves pain from a faulty artificial hip or strange symptoms after taking testosterone. In this case, write down when you first discovered the melanoma on your skin, what pain you may be experiencing (if any), what your doctor tells you about your treatment, what medical care you’ve received, etc. If the information is related in any way to your skin cancer, write it down. This journal will assist you in getting back to health, and it may also assist your attorney with a possible court case down the road. A melanoma journal (for lack of a better name) can provide extremely valuable information to an attorney putting together the best case for you in the event you have a viable claim against a pharmaceutical company for a harmful drug like Viagra.

5. Maintain Records of Medical Bills, Expenses

Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your medical care related to the melanoma, including surgeries, chemotherapy and radiation treatments, recovery, rehabilitation, medications, etc. In some cases, pharmaceutical companies will pay the out-of-pocket expenses of a victim of a failed drug like Viagra. In addition, keep detailed records of all time missed from your employment, including sick days which you were forced to use, and days out of work for which you lost compensation.

6. Call an Attorney You Trust

Let me say this: the scientific study linking melanoma to the use of erectile dysfunction drugs like Viagra, Cialis, and Levitra is in the early stages. Studies so far show an increased risk of developing melanoma among men who use these drugs, but we still need to look more closely at the connection. That said, a multi-district litigation site has already been established for the dozens of lawsuits filed against Pfizer, the manufacturer of Viagra, and I suspect we will shortly see MDLs against the makers of Cialis and Levitra, as those drugs work in the body in similar ways to Viagra. For more information on choosing the right product liability lawyer, you can check out my posts here and here and here. You can also simply call me for more information: (919) 830-5602.

Note: I am no doctor. As a product liability attorney, of course I can’t diagnose your health issues and cannot connect any injury you may have suffered to Viagra or to any other drug. Please see your doctor immediately if you suffer any negative health issue (related to the use of Viagra or not). That said, the general recommendations in this post are common-sense and reasonable, and consistent with the research I have done on this class of drugs.