Email Between J&J and Consulting Doc over “Experimental” Transvaginal Mesh Raises Ethical Questions

An email correspondence between Johnson & Johnson and a consulting doctor has many questioning the relationship between industry and healthcare professionals. The email, which was unveiled in legal discovery related to the ever-growing transvaginal mesh litigation, show that J&J were worried because the American College of Obstetricians and Gynecologists referred to the pelvic mesh as “experimental”. The original memo said “Given the limited data and frequent changes in the marketed products…the procedures should be considered experimental and patients should consent to surgery with that understanding,” according to Mass Device.

J&J was concerned that the term “experimental” would scare off patients and even lead to insurance companies refusing reimbursements. They asked Dr. Vincent Lucente for advice. Lucente was a consultant for the company for ten years, during which time was paid $800,000; as a consultant he influenced language used in medical trade publications. Wall Street Journal reports that after the bulletin was changed, he gloated about it in a corresponding email to J&J, writing “Note, no further use of the word experimental!…Well, this is one I’m taking credit for. I led the charge on this and never thought we would get a complete replacement of the earlier bulletin.”

Bulletin writers said the change was dishonest and rebuked physicians who supported it. In a letter to the editor of the International Urogynecology Journal, original bulletin co-author Dr. Anne Weber wrote “Most of the clinicians who objected to the use of the word ‘experimental’ understood only too well exactly what meaning was intended…Such clinicians were concerned that insurance companies would not cover procedures labeled experimental.”

Transvaginal mesh implants are supposed to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), but instead they have become notorious for painful and sometimes permanent complications, including:

• mesh erosion through the vagina (also called exposure, extrusion, or protrusion)

• pain

• infection

• bleeding

• organ perforation

• urinary problems

The U.S. Food and Drug Administration (FDA) has warned that complications linked to transvaginal mesh are “not rare”. Transvaginal may actually present more risks compared to other methods, the agency said.

J&J is not the only one facing litigation over transvaginal mesh. Many manufacturers, including Boston Scientific, C.R. Bard and Endo are being sued over injuries allegedly caused by the devices. A number of the lawsuits point out the fact that transvaginal mesh products were never clinically tested before they were approved and sold due to a regulatory loophole.

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