Annalise (not her real name) 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, silicone was everywhere in every tissue tested—and in unusually high amounts.1
Thanks in part to celebrities like Katie Price and Kim Kardashian, who openly share their body-enhancement surgery on social media, breast augmentation remains the most popular form of plastic surgery on both sides of the Atlantic. Of the 14 million cosmetic surgeries Americans undergo each year, approximately 300,000 procedures are for breast enhancement. In the UK after 2014, breast implants declined slightly in popularity, with operations down 20 per cent, after celebrities like Victoria Beckham openly decided to opt for removing their implants to achieve a more natural look.
Nevertheless, boob jobs have maintained their position as the most popular form of plastic surgery over here as well, with nearly 9,000 British women still opting to have their breasts enhanced every year.
Medicine has been experimenting with breast enlargement for more than a 100 years, inserting paraffin and animal fat into breasts, before alighting on the idea of injecting silicone directly into the breasts of Japanese women after the Second World War to make them more closely resemble the American ideal. But it wasn’t until 1962 that 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.
Unbelievably, for a procedure that’s carried out on 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 (see right), and side-effects continue to be papered over with blithe assurances that the procedure is perfectly safe.
There have been two scandals involving breast implants. The first was in the late 1990s, when three US manufacturers of silicone breast implants—Dow Corning Corporation, Bristol-Myers Squibb Co. and Baxter Healthcare Corporation—agreed to pay $3.7 billion to women claiming injuries from breast implants, the largest settlement ever negotiated in a class action lawsuit at the time.
The second scandal was in 2010, when a brief protest was heard following revelations that French company Poly Implant Prothèse (PIP) had been filling their products with industrial-grade silicone, ordinarily used to make mattresses, rather than medical silicone, and selling them throughout Europe (including the UK)—particularly after eight women whose PIP implants had ruptured developed a rare form of lymphoma and died.
Nevertheless, after the scandal quieted down, the most important question continued to be ignored: just how safe are implants, or are they yet another form of slow-motion poisoning? And how likely are they to leak?
Kappel is categorical on that latter possibility. “Gel bleed is a phenomenon that is inherent to all types of models of silicone breast implants, regardless whether they are soft and round or cohesive anatomically shaped,” she and her colleagues from the Radboud University Nijmegen Medical Centre in The Netherlands concluded. The question is not whether, but simply when. “The bleed retardation layer in the late models retards the bleeding, but does not abolish it.”
Currently, there are two types of implants. The latest so-called ‘bleed retardation’ silicone variety has a silicone layer, or shell, filled with a ‘gummy-bear’ jelly-like form of silicone. The saline variety has a silicone envelope, but is either prefilled with saline, or salt water, or inserted empty and inflated with saline through a valve during surgery.
Before you consent to get your breasts done, consider what we know thus far.
Complications are very common. 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, and involved 19 per cent of the implants.
The problems included ‘capsular contracture’ (where scar tissue formation around the implant causes it to harden and contract, making it hard and painful), rupture, haematoma and wound infection.2
All implants will eventually rupture. Silicone gel implant failure includes contracture, rupture, leaking, visible tears and complete breakdown. Research from the University of Maryland found that 64 per cent, or nearly two-thirds, of implants that have been in the breast for one to 25 years will rupture or leak.
Almost all patients can realistically expect to have implants intact after eight years, but that falls to half of all patients after 12 years and very few (only 5 per cent) after 20 years. As a result, FDA researchers now recommend implant removal within eight years,3 but they don’t highlight that removal of scar tissue also often removes significant natural breast tissue. In a study of 100 women who requested getting their silicone implants removed, 57 per cent had already ruptured or were leaking.4
In the UK, rupture has even been given a name: the Jordan syndrome. Ruptures have increased fivefold to more than 1,500 cases in 2012–2013, said plastic surgeon Douglas McGeorge, as women ask for giant breasts to copy glamour model Katie ‘Jordan’ Price, who enhanced her breasts to a 32GG.
Silicone exposure has long been linked to autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, progressive systemic sclerosis and vasculitis. But because the FDA continues to downplay this possibility, women who react to it are labelled as having ‘silicone implant incompatibility syndrome’ (SIIS) or ‘autoimmune/inflammatory syndrome’.
In a study of 32 women, all 32 had evidence of SIIS; 17 of them had a systemic autoimmune disease, and 15 had damage related to immune-related antibodies, proteins and antimicrobial molecules.5
What’s more, in three sisters who had all received silicone implants and suffered from arthralgia, myalgia and sleep disturbances, these complaints were all improved as soon as their breast implants were replaced by a non-silicone gel.6
Implants often kill sexual sensitivity. In the above study of 100 women, 75 per cent reported they’d lost some sensitivity in their nipples following breast augmentation and, in more than a third of those women, the loss of sensitivity was nearly complete.4
Bacteria and mould can grow within saline implants. As the silicone envelope is semi-permeable, studies have shown that saline-filled implants, particularly those with a valve through which the saline was injected, can harbour the growth of dangerous bacteria like Staphylococcus aureus and Escherichia coli, and fungi like Aspergillus flavus, wreaking havoc on health.7
Implants may prevent you from breastfeeding, though it depends on how the operation was done. In one Texas study, 64 per cent of women with breast implants had too little milk to breastfeed compared with only 7 per cent of those without implants.8 Incisions around the nipples were most likely to cause the problem, although other incisions also made it significantly more difficult for women to breastfeed.
Implants may harm your baby. Research from the Schneider Children’s Hospital in New York suggests that the babies of women with breast augmentation may also be at risk of developing autoimmune disorders.
Of 11 children, aged 18 months to 13 years, with long-standing abdominal pain, six of them had been breastfed by mothers with silicone implants. These children also had a host of other symptoms, including recurrent vomiting, swallowing difficulties and irritable bowel syndrome. Some had joint pain and periodic rashes, but they all had abnormal function of the oesophagus (the tube that connects the throat to the stomach).9
Implants can cause cancer. France’s National Cancer Institute issued a cancer warning on implants after finding a link with anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma (NHL) that usually affects the lymph nodes, soft tissues and liver. This was confirmed by a multicentre European study, which found 71 cases of this rare cancer linked to breast implants.10 The FDA acknowledges that the risk is ‘very low’ but nonetheless increased.
Implants can increase the risk of suicide. A review of all the available studies so far found that women are up to 12 times more likely to commit suicide after having implants. And women who had implants because of mastectomies are 10 times more likely to commit suicide than those who didn’t undergo reconstructive surgery. None of the women in these studies had any pre-existing mental health problems.11
The scandalous truth is that silicone breast implants have been used in millions of women for 50 years before they’d ever been approved by safety studies and, to date, there have still never been any long-term independent studies. One typical pooled analysis of all the epidemiological evidence concluded there was no evidence of a “link with connective tissue disease.12
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 company and partly owned by BellSouth Corp.
Non-regulation through the years
1967 - The first implant devices are created by filling an ‘envelope’ of silicone with saline, or salt water, but silicone devices take precedence as the material of choice for plastic surgeons.
1976 - The FDA gains regulatory authority over implants. As they’d already been used for nine years in thousands of women without regulation, the FDA allows the implants to be ‘grandfathered in’ without having to undergo the usual safety tests.
1992 - After thousands of complaints of similar autoimmune symptoms, the FDA restricts the use of silicone implants to only breast reconstruction patients and those opting for augmentation who agree to take part in clinical trials.
1998 - Dow Corning, Bristol-Myers Squibb and Baxter Healthcare agree to a payout of $3.7 billion to settle claims by more than 170,000 women that implants harmed their health, with Dow footing $3.2 billion
of the bill.
1999 - The Institute of Medicine (IOM) releases a report declaring there is insufficient evidence to establish that silicone and saline breast implants cause “systemic health effects”.
2003 - The FDA approves Inamed (now Allergan) saline breast implants, touted as safer than silicone, based on one-year safety data, but declines approval of the company’s silicone implants.
2005 - An FDA advisory panel suggests approval of MENTOR’s silicone implants, but not Inamed’s silicone implants, but this advice is rejected by the FDA, which approves both products.
2010 - French company Poly Implant Prothèse (PIP) admits to filling its products with industrial-grade silicone, rather than medical silicone, following eight deaths due to cancer from their ruptured implants.