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Home >> Surgical Mesh >> Kentucky Attorney General Sues Johnson & Johnson Over Deceptive Pelvic Mesh Marketing
Kentucky AG Andy Beshear

Kentucky AG Andy Beshear

Women’s Health Litigation, August 15, 2016 On Monday, August 15, the Commonwealth of Kentucky and Attorney General Andy Beshear brings the action against Ethicon of Somerville, NJ and Johnson & Johnson of New Brunswick, New Jersey. The allegations include deceptive pelvic mesh marketing of medical devices for women including transvaginal mesh, a synthetic woven fabric implanted through the vagina to treat common pelvic floor conditions.   About 15,000 women in Kentucky had these devices implanted without J&J providing sufficient information to allow them to weigh the risks v the benefits.

Here is the lawsuit.  

Approximately 30 to 50% of women will experience prolapse in their lifetime says the complaint.  J&J failed to disclose clinically relevant information about the use of these devices and in doing so impaired the doctors’ ability to provide informed consent to their patients.

J&J concealed and misrepresented to doctors and patients the risks such as chronic pelvic pain, urinary and or defecatory dsfunction, pain with intercourse, loss of sexual function and the potential irreversible nature of these complications. Many of these risks are not present in a non-mesh surgical alternative which was not revealed, says the  complaint.

Kentucky now joins Washington State and California in AG lawsuits against J&J for  bring its mesh products to market deceptively.  See background story on Mesh News Desk here. 

The marketing called these devices “minimally invasive” with “minimal risk” without disclosing the permanent debilitating complications.  The company persisted in misrepresenting the risks of surgical mesh despite receiving complaints such as “She will likely lose any coital function as her vaginal length is now 3cm… This patient will have a permanently destroyed vagina.”

The injuries can end marriages, cause permanent disability and a series of removal surgeries. Women say “The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball.   The thought of living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent miserable sex, and marital problems was almost more than I could bear.”

Another woman wrote, “I experienced excruciating pain from day one. I felt as thought my urethra was being strangled, I wouldn’t pee, walking was out of the question, sitting was agony, and I couldn’t lie on my left side due to severe pain… Over the course of the next 14 weeks I visited/was admitted to the [hospital] 10 times… I had no quality of life. My consultant likened the mesh removal as to ‘trying to removing chewing gum from hair.’  He had to shave the mesh from my urethra as it was so badly eroded… Since the resection I have started to feel relief, however, I still suffer left side and groin pain and numbness, buttock pain, sharp pains in my lower stomach and I am less continent now than I was pre op.”

J&J’s concealment of the severity of risks is even more egregious because women suffering from POP or SUI could have had a non-mesh surgical alternative. No non-mesh treatment alternative for POP and SUI is life threatening.Ethicon prolift package 200

J&J makes the TVT which it began selling in 1997; the TVT Retropubic; TVT Exact; TVT Obturator; TVT Abbrevo; TVT Secur. For POP there is the Prolift and Prolift+M and the Prosima.

Complications include mesh erosion, extrusion, infection, chronic foreign body response, chronic inflammation, bacterial colonization and related infection, mesh contracture, mesh shrinkage, nerve entrapment, vaginal shortening anddistortion, chronic pain permanent dyspareunia and sexual and urinary and defecatory dysfunction.  Mesh removal surgery is difficult and often impossible. The removal can often cause additional problems that can require additional surgeries.

Specifically what J&J Did:

FDA Approved – The company said its products were “FDA approved” even though they were cleared by the hands-off 510(k) process requiring only the naming of a “substantially equivalent” predicate device already on the market. The 510(K) clearance required about 20 hours to time.

Complications Missing from product label – The list is long of those complications associated with mesh.

Dr Axel Arnaud, MD from Linda Gross trial

Dr Axel Arnaud, MD from Linda Gross trial

Employees of J&J Urged Warnings – Even when insiders urged J&J to do a better job to warn doctors and patients, the company failed to act. For example, J&J Medical Director Dr. Axel Arnaud wanted to add a warning for sexually active women. In a June 2005 email he suggested mesh placement could lead to vaginal erosion and retraction that can distort anatomically the vagina and interfere with sexual intercourse.  The risk is associated with hysterectomy.  The company never incorporated this statement into any promotional materials for POP mesh.

Dr. Meng Chen, a medical director in the complaint review department urged an updated IFU (Instructions for Use) concerning SUI mesh. She would take in complaints from the public and very frequently heard tape exposure, erosion and extrusion. Patients told her they did not have adequate pre-op consent and their quality of life now involved dyspareunia (painful sex) and often they had to undergo tape removal with post-op complications that were never included in the warnings.  J&J continued tofail to include these warnings.

J&J Knew but failed to warn – Surgical mesh triggers a lifelong chronic foreign body reaction and chronic inflammation.  J&J called this “transitory.” J&J knew the risk of mesh erosion, contraction, shrinking and folding and hardening of the mesh inside the body could lead to chronic pain and dyspareunia.  J&J knew there was a heightened risk of infection with its mesh as the bacteria occurs due to implantation through the vagina. Bacterial colonies reside in the woven mesh. Instead J&J said the mesh “does not potentiate infection” in its marketing materials.  J&J knew its mesh can shrink and harden and become rigid.  Documents from the J&J LIGHTning Critical Strategy dated September 26, 2006 confirms the company understood mesh retraction or shrinkage can cause anatomic distortion in the vagina which can have a negative impact on the sexual function.  Scar plate of the mesh causes stiffness of the vagina.  Instead, the company said its mesh is “supple” and “remains soft and pliable.”  J&J also said its mesh is “inert” meaning it would not trigger a foreign body response contract or harden.  J&J failed to disclose there was no safe and effective way to remove its surgical vaginal mesh.  J&J failed to disclose mesh erosion can occur any time after the implantation, even years later.  Erosion is the most common and consistently reported mesh-related complication which can lead to serious complications.  J&J said its mesh would cause no sexual dysfunction when it knew mesh erosion could lead to painful sex permanently and even abrasions to one’s sexual partner.

At the same time J&J touted surgical mesh as superior to native tissue repair by falsely inflating the failure rates of non-mesh surgical options.

Dr. Ulf Ulmsten, MD

Dr. Ulf Ulmsten, MD

J&J Downplayed Severity of Complications – The company selectively cited outcomes of studies from Dr. Ulm Ulmsten who was selling his studies to J&J if he reached certain favorable results.

The AG request the company be permanently enjoined from further and repeated violations of its Consumer Protection Act and that J&J pay $2,000 per violation and $10,000 for each violation targeted to consumers over the age of 60.

KY also asks for reasonable costs and fees and for a trial by jury. ###

 

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