Serious safety concerns about breast implants given to thousands of women each year have been revealed in an investigation into the $1bn (£780m) industry.
A global project involving the Guardian found wide-ranging concerns around the way breast implants were approved for clinical use and the failure to track the long-term outcomes of surgery.
The disclosures come from a series of freedom of information (FoI) requests, analysis of official health records and interviews in several countries by members of the International Consortium of Investigative Journalists (ICIJ).
The investigation found:
More than 1,200 serious incidents linked to breast implants have been reported in the UK since the start of 2015.
Links made between popular textured implants and a rare type of cancer.
The use of non-clinical-grade materials by leading manufacturers, according to evidence found by Dutch investigators.
Huge numbers of women missing from clinical trials designed to monitor safety.
Reports of ruptured implants, pain, disfigurement, allergic reactions and other symptoms.
In the past, large-scale clinical studies of breast implants found low rates of serious complications and most women reported being satisfied after surgery.
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However, there is growing evidence that a significant number of women also experience problems and that in many cases the long-term outcomes are not tracked.
An analysis by the Guardian showed the UK’s regulator received 1,459 reports of incidents related to breast implants in the last three years, more than 1,200 of which were serious.
The reports came from patients and healthcare workers, and included cases where implants caused an allergic reaction, pain, psychological problems and, in three quarters of cases, the need for another operation.
The data, which was revealed after a FoI request to the Medicines and Healthcare Products Regulatory Agency (MHRA), only showed reports that had been made through its “yellow card” scheme, which gives patients a way of raising issues.
The data did not explain the cause of the problem and the regulator said it was not allowed to release details about which company’s devices were involved with each problem.
A third of reports involved “material separation” – which may mean the shell and the inside of the implant came apart or ruptured in some way. A quarter of the reports involved a leak.
In 11 cases the implant was recorded as having “migrated”, and in six it had burst. Fifty-seven reports involved anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin lymphoma that affects the immune system.
These issues are likely to have led to women needing to have their implants surgically removed and replaced.
The investigation also revealed ongoing inadequacies in oversight, nearly a decade on from the PIP scandal in which a French firm fraudulently sold hundreds of thousands of implants containing industrial-grade silicone.
Australia has set up a national breast devices database, but even there experts say they struggle to get information quickly enough.
In the UK, 90% of NHS and private clinics that have registered to provide data to the new national breast implant registry have done so, although it is not clear how many have signed up.
Nigel Mercer, a plastic surgeon who advises the MHRA on breast implants, said the registry was vital for revealing problems, but needed to be compulsory. “Without the registry we have no idea how big a problem is. It does make sense from a public health point of view for it to be mandatory.”
The ICIJ project has uncovered problems in a number of other countries.
Two years ago, an investigation by the Dutch health regulator into Europe’s 10 leading suppliers of silicone breast implants uncovered serious shortcomings in the companies’ testing of products and safety procedures.
Chemical analysis of the implants showed some contained different materials to those listed, with one product containing industrial-grade silicone, comparable to that found in the banned PIP implants.
Half the companies were found to have underplayed the risks of breast implants in documentation and seven were found to have poor assessments of biocompatibility.
Only three had well-defined criteria for safety alerts or recalls, which the regulator said could lead to late or no discovery of problems with safety or performance.
In several countries, including the US and Canada, evidence was found of manufacturers corralling hundreds of patient complaints into single “adverse incident” reports filed to regulators, masking the true frequency of complications.
Last year in the US, the the Food and Drug Administration (FDA) ordered companies to file adverse events individually, rather than allowing them to report huge numbers of cases in one go.
This led to a dramatic rise in the number of reports linked to breast implants – from 353 in 2016 to 4,651 in 2017, and 8,352 in the first six months of 2018.
The FDA has scheduled a public meeting next year of the panel that oversees breast implants to help promote transparency and “more dialogue on the issue”.
A recent large-scale study in the US confirmed links between breast implants and a range of rare illnesses, including several linked to the immune system. The study examined the findings of two of the largest implant makers, Allergan and Mentor, when they tracked 100,000 women with their products.
While the majority of those who took part said they were satisfied with their implants, researchers found women had higher incidences of Sjögren’s syndrome and scleroderma than the general population.
Sjögren’s syndrome causes symptoms including a dry mouth and eyes, and swelling of the jaw, while scleroderma results in the immune system attacking the connective tissue under the skin and around internal organs.
There were also higher incidences of rheumatoid arthritis, stillbirth and melanoma.
The report concluded: “This study demonstrates silicone implants are associated with an increased risk of certain systemic harms.”
Mark Clemens, one of the report’s authors, said: “We did see a statistical association with rare diseases. There were diseases that women with implants had at a higher rate than the general population’s and we need to study that further.”
Clemens, an associate professor in plastic and reconstructive surgery at the MD Anderson Cancer Center in Houston, US, stressed that proving a link was not the same as proving causation, and that working out how the two were associated would require studying the patients who had experienced problems.
Another issue raised by the researchers was the high number of women who went missing from the studies. Mentor’s spokeswoman, Mindy Tinsley, said the original studies used as the basis for this article were replaced because they were considered inadequate to determine associations with rare health effects.
Tinsley said the science and long-term data from multiple clinical studies supported the safety and clinical performance of breast implants. “Mentor continues to provide surgeons and patients with transparent and balanced information so that they can evaluate the benefits and risks associated with breast implants prior to making decisions.”
Allergan said in a statement: “Patient safety is Allergan’s highest priority and we continue to collaborate with clinicians, societies and worldwide regulatory authorities to advance research, understanding and awareness about breast implant effectiveness and safety.
“The safety profile of Allergan’s breast implants is supported by extensive pre-clinical device testing, more than a decade of US and European clinical use, as well as a large number of peer-reviewed and published studies.”
But Paul Harris, the president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said more research needed to be done to establish the long-term potential health effects.
“Lots of patients do report symptoms which have been grouped together under the name breast implant illness. We don’t know if they are associated with implants – although some of them do have the implants removed and feel better.”
He added: “In my opinion there is not enough emphasis on post-market surveillance and how these devices perform in patients.”
Figures from the International Society of Aesthetic Plastic Surgery show 1.7m breast augmentation operations took place in 2017, while there were 170,000 surgeries to remove implants.
Harris said: “Overall the safety of breast implants is extremely high. For women who have had reconstruction, perhaps after breast cancer, or because of congenital asymmetry, breast implants are performing a very worthwhile job.”
