This is a true story, with just her name changed. Annalise decided she would not die in vain. The Dutch resident suffered for years with pain and a host of strange undiagnosed symptoms before contracting the breast cancer that would eventually kill her.

Before her death at the age of 56 in 2008, Annalise decided to donate her body to medical science to find out the truth about why she’d developed cancer. Dr Ruth Kappel, a plastic and reconstructive surgeon in Zwolle, The Netherlands, led the pathology team that dissected the body.

This is a true story, with just her name changed. Annalise decided she would not die in vain. The Dutch resident suffered for years with pain and a host of strange undiagnosed symptoms before contracting the breast cancer that would eventually kill her.

Before her death at the age of 56 in 2008, Annalise decided to donate her body to medical science to find out the truth about why she’d developed cancer. Dr Ruth Kappel, a plastic and reconstructive surgeon in Zwolle, The Netherlands, led the pathology team that dissected the body.

Through special instrumentation using light and electron microscopy and X-ray analysis of the body’s internal organs and nervous system tissue, the key to Annalise’s suffering stood starkly revealed.

She’d had breast implants 17 years before, and the silicone had migrated throughout her body—even to distant organs—her ovaries, her thyroid, her bladder and throughout her spinal cord. In fact, it was everywhere in every tissue tested—and always in unusually high amounts.

Thanks in part to celebrities like Katie Price and Kim Kardashian, who openly share their blow-by-blow body-enhancement surgery on social media, breast augmentation remains the most popular form of plastic surgery on both sides of the Atlantic. Every year, for instance, some 300,000 women and teenage girls go under the knife for breast enhancement in America alone.

But here’s the amazing part of it. Unbelievably, for a procedure that’s carried out 5-10 million women all over the world every year, to this day the implant and surgical procedure have never undergone proper, long-term, impartial safety trials.

For nearly half a century, in fact, implants had no safety studies at all.

Bigger boobs with your tattoo, madam?
In 1962 the first silicone implant was created, undergoing testing on a single dog before being implanted into a Southern American woman who simply sought to have a tattoo removed, but the FDA didn’t get regulatory authority over implants until nine years later.

But because by then the devices had been already inserted into tens of thousands of women, the agency allowed implants to be ‘grandfathered in’ without having to undergo the usual safety tests.

Sixteen more years passed by before the FDA was moved to impose the first restrictions on the availability of silicone implants, but only after tens of thousands of women were complaining of strange autoimmune conditions.

Six years later, Down Corning Bristol-Myers Squibb and Baxter Healthcare paid out $3.7 billion to more than 170,000 women who claimed that implants had harmed their health – the largest class action of its time.

Nevertheless, it took six more years – more than four decades after the first implant went into that tattooed Texan – for the FDA to evaluate and approve a saline-filled product, on the basis of a one-year safety trial.

Finally, two years after that, in 2005, overriding the objections of its own advisory panel on the insufficient safety of one brand, the FDA gave two more brands of silicone implants its stamp of approval.

Through all of this rough-shod regulation, the important question continues to be ignored: are implants yet another form of slow-motion poisoning? And how likely are they to leak?

Not whether, but when
Ruth Kappel, the doctor who carried out Annelise’s autopsy, is categorical on that latter possibility. “Gel bleed is a phenomenon that is inherent to all types of models of silicone breast implants,” she and her colleagues concluded.

In other words, the question for every last model out there is not whether it leaks, but simply when.

The University of Maryland found that nearly two-thirds, of implants that have been in the breast for one to 25 years will rupture or leak. Leaks will happen to half of all patients 12 years. In a study of 100 women who requested getting their silicone implants removed, 57 per cent had already ruptured or were leaking.

The evidence is clear that silicone exposure is linked to all manner of autoimmune diseases, even a rare form of cancer. And saline implants, which can harbor dangerous bacteria and other microorganisms, are no better in terms of the havoc they can wreak.

The Mayo Clinic carried out a major study of 749 Minnesotan women who’d had implants during 1964–1991. Complications arose in 178 of them, or 24 per cent, involving 19 per cent of the implants.

The hellish illness caused by implants often makes life no longer worth living. After having implants, according to one major review, women are up to 12 times more likely to commit suicide. Even women who get implants after mastectomy are 10 times more likely to kill themselves than those who don’t get reconstructed.

Meanwhile, the truth about implants continues to be papered over with blithe assurances that the procedure is perfectly safe.

One typical analysis of all the epidemiological evidence concluded there was no evidence of a link with autoimmune connective tissue disease. But that review was carried out by the International Epidemiology Institute in Maryland.

When it came to evaluating mobile phones, the IEI carried out a study costing nearly $400,000 concluding that mobile phones don’t cause brain cancer.

One of its funders? Tele Danmark A/S, one of Denmark’s largest phone companies, partly owned by BellSouth.

This year, while we’re talking up revolution in America, here’s yet another reason to make reform of the FDA a campaign issue and to insist that the new government fire all those good ol’ boys who are in bed with industry and busy defending lady killers like this.