Johnson & Johnson sold a faulty vaginal mesh implant that left tens of thousands of women in agony despite knowing the risks before it hit the market, a new report claims.
Internal emails seen by the Guardian show executives at the pharmaceutical company had been briefed on the product’s flaws – namely that it could turn extremely rigid, inflict serious pain, and could be near impossible to remove.
In May 2004, before the product was launched, a member of staff warned others that the mesh could turn ‘hard as a rock’ and could bend like a ‘folded potato chip’ after implantation, while another said its capacity to shrink ‘may lead to pain’.
And yet, months later, the device was launched and promoted, and over the next seven years tens of thousands of women unwittingly followed their doctors’ advice to undergo the operation which would change their lives.
Now, Johnson & Johnson’s internal dealings are coming to light amid a series of lawsuits, the latest of which comes from Suzanne Emmett, 60, from Pennsylvania, who says she now suffers incontinence, chronic pain, and sexual dysfunction.
Executives at Johnson & Johnson had allegedly been briefed on the flaws – that it could turn rigid, inflict serious pain, and could be near impossible to remove.
Vaginal meshes, designed to treat urinary incontinence, cannot be easily removed.
‘Mesh’, the noun, refers to netted wire material that the device is made of.
It was a cruelly ironic accident that the verb applies too: it meshes with a woman’s pelvic tissue, which grows around and binds to the wiry structure. If the mesh solidifies, twists, or shrinks, it tugs on the woman’s nerves.
Surgeons risk damaging the organs if they try to remove it, and even then, they will likely only remove parts of it.
Johnson & Johnson has protested ignorance to warnings of these particularly crippling side effects.
The company continued to promote the devices even as reports of severe outcomes emerged.
The Guardian reports that in 2007 executives debated over email how to put a positive spin on the product in light of injury reports that sparked alarm in the American College of Obstetricians and Gynecologists (ACOG).
It seems their plan worked.
ACOG had warned their members that the device should be treated as ‘experimental’ due to the high rate of injuries.
A doctor – who received almost $2 million in kick-backs from J&J over 12 years – allegedly advised the firm to find a female physician ‘with no strong industry ties’ to vouch for the product.
Seven months later, ACOG removed the phrase ‘experimental’ from their advisory.
The doctor claimed credit for the turn-around in subsequent emails, the Guardian reported (meriting an effusive response from ‘a J&J marketing director’ who allegedly replied: ‘I am doing the happy dance! I love you man!’)
Responding to the Guardian’s allegations, the doctor said he did not lobby to twist ACOG’s phrasing, he contacted them to change an inaccuracy.
Johnson & Johnson refused DailyMail.com’s request for a comment.