Most meshes made for pelvic or hernia repair are heavy weight, small pore mesh. Small pore is considered anything one mm or less. Johnson & Johnson’s small pore, heavyweight mesh is known by its proprietary name Prolene. Whether used to treat incontinence in the form of a sling or hammock, or for pelvic floor repair or hernia, Prolene is the go-to standard polypropylene (PP) mesh that is still used by J&J today.
Years ago, Ethicon, the medical device division of Johnson & Johnson, promoted a lighter weight, larger pore mesh. Ethicon understood the problems with the small pore mesh. It does not always incorporate well in the body. It can shrink and contract, forming a hard scar plate and taking with it nerves and tissues, diminishing the patient’s quality of life. Ethicon produced several videos promoting its lighter, smaller pore mesh. At least one was hosted by hernia surgeon, Dr. Todd Heniford, M.D., now at Carolinas Hernia Institute. Heniford is a leading hernia surgeon and at one time the president of the American Hernia Society and a consultant to Johnson & Johnson. “This is not a 100% benign procedure,” he has said about mesh complications, looking for a better way.
In one 2007 video entitled, “Benefits of Lightweight Meshes,” Dr. Heniford takes an explanted mesh. It resembled a lamb chop with a handle which he grips, and bangs it on the side of a table. It makes a discernable sound like hardened plastic. In the video, Dr. Heniford say that “heavyweight meshes should not be used anywhere in the human body, and there is no excuse to continue to do so.”
Whoops. Today Ethicon continues to promote its Prolene for pelvic and hernia repairs. But back then, Dr. Heniford was touting the marvels of Ethicon’s new lightweight mesh, Ultrapro, which he tested for Ethicon. With large pores of 3 to 4 mm, it is less than half the weight of Prolene. Dr. Heniford thought UltraPro mesh used for hernia repair could avoid contraction, erosion and caused less inflammation in the body.
Bruce Rosenberg was enrolled in the human trial for Ultrapro. Bruce, now a hernia patient advocate, often attended American Hernia Society meetings. After one, he called Ethicon to inquire about its videos on lighter meshes. He used his real name. Rosenberg received a DVD in the mail. It was the tape hosted by Dr. Heniford. While Ultrapro is still on the market, in Bruce Rosenberg’s case, he was told his hernia defect was too large for this light weight mesh and his body was too thin. A lighter mesh can lead to more ingrowth of soft tissue and have less shrinkage, but may not be strong enough to avoid a recurrence of the hernia.
Ethicon claims today there is no videotape available. See Document #953 filed in the pelvic mesh multidistrict litigation #2327. Ethicon was involved in document destruction of approximately 600 pounds of important documents that were provided by Medscand, the original manufacturer of the TVT mesh, even though the documents were under a 2003 litigation hold. Expert witnesses in the pelvic mesh bellwether trials held so far have testified that polypropylene mesh is often too heavy for the task. German Drs. Uwe Klinge and Bernd Klosterhalfen, both have mesh explant labs where they study explanted hernia mesh. They have observed when removed, PP mesh can resemble a hardened piece of plasticized mass inside the body before it is removed.
Bruce Rosenberg knows where the video is. He still has one. He shows it to whoever is interested as part of his nonprofit, Meshoma Foundation, committed to educating the public about the dangers of PP mesh.
Jane Akre is an American journalist based in Florida. In 1997, she was fired from a Fox News while working at a Fox affiliate in Tampa for refusing to include knowingly false information in a report on the safety of a product produced by the Monsanto Corporation. Currently, she is the National News Editor for the Mesh News Desk (MND)—an online news source that covers the complications associated with surgical meshes. Through such reporting, MND looks to put a face on adverse events that affect everyday people.