During the course of surgery, a doctor may need to find a way to connect sections of organs or close wounds. One way to do this is through the use of sutures, a special type of thread. Another way is with the use of surgical staples. The Ethicon surgical stapler is pictured at right.

Doctors commonly use staples over sutures during surgery because they offer several advantages, including:

• Lower risk of infection
• Speed of insertion
• Reduced adverse reaction to surrounding tissue

Two of the major manufacturers of surgical staplers in the United States include Covidien and Ethicon. This blog post will focus on Ethicon’s staplers, in particular those involved in its most recent recalls.

History of Problems with Surgical Staplers

Despite their advantages, widespread use and overall general safety, surgical staplers and staples do not have a perfect operational record. They have caused a variety of problems for patients, including:

• Tissue and organ tearing
• Postoperative connection leak
• Hemorrhaging
• Hemorrhagic shock
• Fistulas
• Sepsis
• Bleeding
• Death

These problems can be caused by surgical staplers can malfunctioning in several ways:

• Misfiring of the stapler
• The stapler failing to fire
• Improperly formed staples
• The staple line opening

Countdown to Recall

As a result of these problems, various stapler manufacturers have recalled their products and the U.S. Food and Drug Administration (FDA) has made several announcements regarding these issues. Here is a brief timeline of recent events:

March 8, 2019: The FDA issues a letter to health care providers describing the adverse events associated with surgical staplers and staples. The FDA mentions that from January 1, 2011 to March 31, 2018, the FDA received reports that included 366 deaths and more than 9,000 serious injuries.

April 11, 2019: Ethicon issues a recall for circular staplers because they do not fire properly and fail to correctly form staples when fired. The FDA classified this as a Class I recall, the most serious type, as they involve devices that could result in death. This recall applied to approximately 92,496 devices in the United States.

April 23, 2019: The FDA issues draft guidance. This is a proposal for new recommendations for surgical stapler and staple manufacturers requiring they include additional information on product labels.

April 24, 2019: The FDA issues a proposed order to change surgical staplers and staples for internal use from Class I medical devices to Class II medical devices. This change, if adopted, would allow the FDA to implement special controls to make the products safer.

May 30, 2019: The FDA holds an open meeting to discuss reclassifying internal surgical staplers and staples from Class I to Class II medical devices.

October 3, 2019: Ethicon issues a recall for Echelon Flex Endopath Staplers due to their failure to properly form staples. The FDA classified this as a Class I recall. More than 5,700 devices in the United States were subject to this recall.

Ethicon’s Most Recent Recall from October 3, 2019

Ethicon’s October 3, 2019 recall involved one product line, the Echelon Endopath staplers. Specifically, they involved the following products:

• Product code: EC60A – Echelon Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter
• Product code: PCEE60A – Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
• Product code: PLEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 44cm Shaft Length
• Product code: PSEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 34cm Shaft Length

The lot numbers, as well as additional information concerning the identification of the specific products being recalled, can be found on the FDA’s Medical Device Recall website.

These staplers are being recalled because the stapler may have a component that is out-of-specification. This could create malformed staples, causing problems in patients. As of the date of the recall, Ethicon publicly acknowledged that the recalled products had caused seven serious injuries and one death.

Litigation Involving Ethicon Staplers

Some litigation has begun and it is ongoing. Concerning the products recalled by Ethicon on April 11, 2019, some individual lawsuits have begun, but are currently in the pre-trial stages of litigation.

As for the products recalled on October 3, 2019, there are few, if any, current lawsuits against Ethicon and Johnson & Johnson, Ethicon’s parent company. If there are any changes, I’ll be sure to let you know in an updated blog post.

Note: The information and images contained in this post were derived from FDA content and news sources.

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.

Treating Hernias with Surgical Mesh

First off, let’s briefly explain what a hernia is. A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it doesn’t 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 usually needed to close the opening and keep it from reopening. This is where surgical 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.

Clinical studies have shown that using surgical mesh to treat hernias reduces the chances of the hernia returning. Each year hundreds of thousands of hernia surgeries are performed. Given their proven effectiveness, it’s no wonder that many of these surgeries use a surgical mesh. Unfortunately, a significant number of the meshes have serious flaws.

more Problems in Patients with Hernia Surgical Mesh

Many patients who undergo surgery to have surgical mesh implanted for hernia treatment recover quickly and go on with their lives. However, some patients suffer from the following problems with their surgically implanted mesh:

– Allergic reactions – Adhesions (scar tissue that sticks together) – Perforation of organs – Return of the hernia – Severe pain – Bowel blockages – Uncomfortable or painful sex – Internal bleeding – Infection – Damage to nerves – Movement of the mesh within the body – Fluid buildup – Rejection of the implant (the body’s immune system attacks the mesh) – Fistulas (an abnormal connection between two hollow areas of the body, like the intestines)

Removal of the surgical mesh is often required, but by the time the mesh is removed, the damage has been done and long-term problems remain. As a result, many patients have sued the manufacturers of these surgical meshes.

Hernia Surgical Mesh Lawsuits

A few years ago, Bard Davol faced numerous lawsuits concerning its Kugel hernia mesh. These lawsuits have been mostly resolved by now, but they appear to represent just the tip of the iceberg.

Patients who have surgical meshes made by other companies are having problems too, and they are starting to line up at the courthouse steps for their day in court. Two major hernia mesh lawsuits involve the following products.

C-Qur

Atrium Medical Corporation manufactured the C-Qur hernia mesh, which is made of polypropylene and coated with Omega-3 fatty acid fish oil. The use of fish oil was intended to reduce the chance of adhesions occurring, but instead has caused many complications. These include allergic reactions to the fish oil, life threatening infections and the fish oil coating separating from the mesh once it is implanted inside the body.

In July of 2013, the Atrium Medical Corporation recalled the C-Qur mesh, with over 30,000 meshes taken off the market. There are currently about two dozen C-Qur mesh lawsuits pending in MDL. However, it’s expected the number of C-Qur lawsuits will grow.

Physiomesh

Ethicon is another company that manufactured a hernia mesh made out of polypropylene called Physiomesh. This mesh had a special coating which was also designed to prevent adhesions. However, the coating led to a complication: It also prevented the mesh from properly integrating into body tissue.

The Physiomesh implant had a larger number of problems that Ethicon did not anticipate, including fluid buildup, scar tissue formation and hemorrhaging. These have led to serious symptoms, such as chronic pain, bowel blockages and infections.

In May of 2016, Physiomesh was withdrawn from the market, although not officially recalled. Currently only a few lawsuits have commenced, although many more lawsuits are anticipated.

Why Did These Hernia Mesh Products Have Problems?

As you might expect, there is no simple answer to this question, but there are two major factors that likely contributed to the problems.

First, the hernia mesh was made out of polypropylene, which was originally considered to be completely inert within the human body. However, studies have shown the polypropylene degrades over time and can damage surrounding tissue.

In order to deal with the problems of polypropylene, medical device manufacturers covered the mesh in special coatings, like Omega-3 fish oil. But these coatings didn’t work very well. So why didn’t companies like Ethicon or Atrium Medical Corporation find a material other than polypropylene?

The answer to this question brings us to factor number two: getting FDA approval as quickly as possible. If a medical device company decided to use a completely different surgical mesh material, it would have taken longer and cost more money to get the product to market. This is because the mesh would have been considered a brand new medical device and therefore full clinical and safety studies and trials and would have been needed. By simply using a new coating, the device would be considered “substantially equivalent” to a medical device already approved by the FDA and therefore would be cheaper and much more readily available to use in patients.

One of the procedures medical device companies used to get their products to market faster was the 510(k) expedited approval process. I’ve written about the 510(k) procedure often on this site. Using this process, Physiomesh and C-Qur didn’t need to be tested in humans; animal tests were considered sufficient.

While there can be advantages of getting medical products to market sooner rather than later, hernia surgical mesh serves as another example of the dangers of not conducting proper tests to ensure a medical product’s safety and effectiveness. Unfortunately, it doesn’t appear these fast-track approval procedures are going anywhere anytime soon given the passage of the 21^st Century Cures Act.

Now What?

The hernia surgical mesh lawsuits are in their early stages with at least one trial set to start in early 2018. It shouldn’t be surprising that more plaintiffs will step forward before then, alleging problems with their hernia surgical mesh.

If you have had a surgical mesh implanted into your body to treat a hernia, especially a product from one of the above mentioned companies, 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.

The Washington Lawsuit

States can sue companies on behalf of their injured citizens. If the state’s attorney general decides that a “bad act” is harmful to enough citizens, her office can file a lawsuit on behalf of the state and the group of people who were injured. It is an important consumer protection function provided by the states. This is what happened in Washington and California a few days ago. The Washington Attorney General reported that 11,728 transvaginal mesh products were sold (and implanted) in women in the state. The attorneys general in those states filed suit against Johnson & Johnson and made a series of chilling allegations against the company for its marketing of transvaginal mesh.

Let’s look at some of the key allegations in the Washington State lawsuit. When I refer to “Defendants,” I mean Johnson & Johnson, Ethicon, Inc., and their related companies, who made and marketed several types of transvaginal mesh.

more Key Allegations:

1. Defendants misled consumers through informational and marketing materials that misrepresented the safety and effectiveness of transvaginal mesh. (Complaint, p. 7)
2. Defendants did not conduct human trials prior to the initial sale of transvaginal mesh. (p. 10)
3. Defendants destroyed the underlying data they claimed supported the safety and effectiveness of their original mesh products. (p. 11)
4. Defendants misrepresented the safety history of the transvaginal mesh to doctors. (p. 11)
5. Defendants made misrepresentations about the mesh directly to consumers through advertisements, brochures, and other marketing materials. (p. 11)
6. Defendants’ marketing materials failed to disclose the possible health complications from implantation of transvaginal mesh. These health problems include incontinence, defecatory dysfunction, dyspareunia (pain during sex), dysuria (pain while urinating), fistula, hematoma, hemorrhage, pain to partner during intercourse, permanent urinary dysfunction, recurrence, pain, UTI, urinary tract obstruction, vaginal scarring, and worsening incontinence. (p. 12)
7. Defendants knew about these mesh health problems but did not report this information. (p. 12-13)
8. Defendants’ Polypropylene Mesh Products present risk of chronic bacterial infection. These infections can occur years after the mesh was removed surgically. (p. 14)
9. Polypropylene mesh degrades and oxidizes in the body over time. This can cause a reaction in the body which can cause chronic inflammation. (p. 14)
10. The transvaginal mesh cannot be removed effectively when the medical device fails. (p. 15)
11. Transvaginal mesh implantation may also cause cancer in women. (p. 15)
12. Defendants knew about problems with sexual function and shrinkage at least as early September 2006, based on the discovery of a Johnson & Johnson internal document. (p. 15-16) Despite this knowledge, J&J sold thousands of mesh products after 2006.
13. Defendants falsely claimed that their transvaginal mesh products were “FDA Approved.” (p. 16) Rather, the mesh products were cleared under the 510(k) equivalency process. (p. 17) I have written about the 510(k) process several times in this blog.
14. Defendants failed to update informational and marketing materials. (p. 18)

Washington State’s Individual Claims Against J&J:

Washington State brought the following individual claims against Defendants:

1. Misrepresentation and Omissions Regarding Safety
2. Misrepresentations or Omissions Regarding Efficacy (the ability to produce a result)
3. Failure to Update Information Provided to Consumers

The State of Washington asked the court to “decree” (to determine, conclude) that Johnson & Johnson engaged in all the bad acts listed in the complaint. It also asked that the court find that J&J engaged in “unfair and/or deceptive acts” in violation of that state’s consumer protection laws. Washington then asked for a permanent injunction which would prohibit Johnson & Johnson from selling transvaginal mesh products in Washington. It also asked for civil penalties for every violation of state law. And finally, Washington asked for “restitution to consumers.”

The Complaint is captioned: State of Washington v. Johnson & Johnson, et al. (Wash. Super. Ct., King Cty.), and is worth reading if you have the time.

Meanwhile, in California

Kamala Harris, Attorney General for California, also filed suit on behalf of California on May 25, 2016. Attorney General Harris stated that Johnson & Johnson sold almost 800,000 pelvic mesh devices nationwide between 2008 and 2014. According to AG Harris, 42,000 mesh products were implanted in California women during this period. On behalf of the citizens of California, Harris sued Johnson & Johnson, alleging false advertising and deceptive marketing of its transvaginal mesh. The lawsuit alleges that J&J failed to inform patients and doctors of possible severe complications and misrepresented the frequency of these risks.

Johnson & Johnson’s Blanket Denial of Wrongdoing

Remarkably, despite more than a hundred thousand serious injuries, thousands of lawsuits, millions paid in jury verdicts and settlements, Johnson & Johnson still contends the mesh product is safe and is the preferred treatment for certain female health issues. According to the Wall Street Journal, Johnson & Johnson responded to the states’ lawsuit by stating, “the use of implantable mesh is often the preferred option to treat certain female pelvic conditions . . . .” As I’ve said before on this site, this blanket denial is a dangerous game for Johnson & Johnson to play, particularly when intentional misrepresentations are alleged.

The Takeaway

An injured person often feels powerless when facing a huge corporation like Johnson & Johnson. And rightly so. No individual, standing alone, can absorb a long legal fight in the same way that a multi-billion dollar corporation can. But when a state gets involved, the fight gets fair. California and Washington can bring the full power of the state to the legal fight against J&J. These lawsuits are therefore a huge step forward in protecting women against future pain and injury from transvaginal mesh. I will keep you posted on key developments in both cases.

Note: Again, I am no doctor. Please call your doctor if you have transvaginal mesh implanted in your body and you have concerns about your health. The information in this post comes mostly from the State of Washington’s lawsuit, which is a public document. I encourage you to review it carefully for further information.

Let’s get back to a look at recent developments with transvaginal mesh lawsuits. In two big victories recently, a Georgia jury awarded $4.4 million to a woman injured by transvaginal mesh, and a New Jersey appeals court upheld an $11.11 million dollar jury verdict.

Transvaginal mesh (TVM) is a plastic mesh product that has been implanted in women for many years to support weakened vaginal walls. Many women suffer from pelvic organ prolapse or stress urinary incontinence, and makers of TVM have insisted that TVM could repair these medical problems. Unfortunately, not long after TVM was marketed and sold, women began complaining of serious health problems, including erosion of the vaginal wall, infections, painful sex, and bladder perforation. The lawsuits followed.

Now let’s take a look at a recent jury trial and an appeal decision of an earlier jury verdict.

more Taylor v. Mentor Worldwide LLC (Middle District Georgia, Columbus)

Products: Mentor ObTape Sling Pelvic Mesh

Jury Award: $4,400,000.00 ($400,000.00 compensatory damages; $4,000,000.00 in punitives)

Date of Jury Verdict: February 18, 2016

Key Takeaway: First win for injured woman against Mentor Worldwide, LLC (which is owned by Johnson & Johnson), with a substantial punitive damages award.

Teresa Taylor is from Marianna, Florida. The Mentor ObTape Sling Pelvic Mesh was implanted in her body in 2004 to treat her stress urinary incontinence. Following implant surgery she began having physical problems, including lower back pain, vaginal burning, painful sex, and incontinence. The ObTape Mesh was surgically removed in 2011. Ms. Taylor filed suit in 2012.

After a nine day trial, the Georgia jury found that Ms. Taylor had demonstrated that the ObTape had a design defect, and that Mentor Worldwide failed to warn her physician of the risks involved in using the ObTape Mesh.

The jury awarded $400,000.00 in compensatory damages (for actual injury, actual pain and suffering), and a noisy $4,000,000.00 in punitive damages.

Among other findings, the jury concluded that Mentor Worldwide was solely motivated by “unreasonable financial gain” in marketing the product. The jury also found that Mentor had intent to harm Ms. Taylor. These findings supported the punitive damages award.

Unfortunately, Florida state law caps punitive damages at $2,000,000.00.

Over 350 ObTape cases remain in the Mentor ObTape MDL. Most of these cases will be settled, but a few may still reach a jury trial.

Mentor Worldwide sold the medical devices between 2003 and 2006. Johnson & Johnson purchased Mentor Worldwide in 2009.

Unless Ms. Taylor can now work out a settlement with Mentor and Johnson & Johnson, the defendants will likely appeal the verdict in the Taylor case. I will keep you posted on these developments.

Gross v. Ethicon, Inc., et al. (New Jersey Superior Court, Appellate Division)

Product: Gynecare Prolift Pelvic Floor Repair System

Appeal Decision: Appellate court in New Jersey upheld jury verdict in favor of injured woman totaling $11.11 million dollars. Court refused to disturb an impressive $7,760,000.00 punitive damages award.

Date of Appeal Decision: April 1, 2016

Recap of the Jury Trial:

In 2006, the Prolift transvaginal mesh was implanted in Linda Gross to treat pelvic organ prolapse. Following implantation, Ms. Gross suffered from mesh erosion, scarring and inflammation. Ms. Gross has eighteen surgeries to repair damage caused by the Prolift TVM.

In 2008 Ms. Gross filed suit in state superior court in Atlantic City, New Jersey. She brought claims against Ethicon, Inc., and Johnson & Johnson for failing to warn her and her doctor about the potential risks of using the Prolift transvaginal mesh product. Ms. Gross also brought other claims, including misrepresentation, defective design, manufacture, and instructions.

Following trial the jury found that the companies failed to warn Ms. Gross of the risks involved with the device, and that this failure to warn caused her injuries. The jury awarded $3,350,000.00 in compensatory damages and $7,760,000.00 in punitive damages. The total award was $11,110,000.00.

Ethicon, Inc. and Johnson & Johnson appealed the jury verdict.

Appeal’s Court Upholds Jury Verdict

In a huge (second) win for the plaintiff, Ms. Gross, the New Jersey Appellate Court upheld the jury’s verdict in a court decision issued on April 1, 2016. The grounds for appeal were complex, and I won’t try to report all the arguments here. But I will say that one key argument was that the learned intermediary doctrine should have applied. The doctrine goes like this: a manufacturer cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (such as the implanting surgeon), who is then expected to communicate with the patient about the benefits and risks of a medical device. The appeals court ruled that it was not error to instruct the jury that the doctrine did not apply in Ms. Gross’s case.

Next, the appeals court held that Ms. Gross and her attorneys provided sufficient evidence to link the lack of adequate warnings about the pelvic mesh to the injuries Ms. Gross suffered. Ms. Gross’s surgeon testified that he would have spent much more time going over the risks involved if he had known about the problems of the Prolift mesh.

Finally, the appellate court held that the evidence presented was more than adequate to support the jury’s decision to award punitive damages.

This is the second big win for Linda Gross. Three years ago her team won a courtroom victory, and now she protected the court victory by successfully fighting off an aggressive appeal by Ethicon, Inc. and Johnson & Johnson. Perhaps this appellate victory will improve the settlement results for the many transvaginal mesh cases that are still in court system and unresolved.