Breast Implants Linked to Cancer - February 2017
Medsafe’s Claims re PIP Breast Implants - August 2012
Breast Implants Revisited - February 2012
Breast Implants Payouts - February 2007
FDA Lifts 14-Year Ban on Silicone Breast Implants - November 2006
Silicone Implants - 2003/2004
Breast Implants Don't Last - July 2002
Breast Implant Compensation Payout - February 2002
From the February 2017 AWHC Newsletter
In December 2016 it was announced on Radio NZ that ten women in New Zealand had been diagnosed with a rare cancer that has been linked to the use of breast implants. Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin’s lymphoma that has in recent years come to be associated with breast implants. The New Zealand numbers were revealed after Australian health authorities said the cancer was more common than previously thought.1
In 2011, the US Food and Drug Administration (FDA) identified a possible association between breast implants and the development of ALCL.2 At that time, the FDA was aware of approximately 60 cases of ALCL in women with breast implants, including 34 cases that were described in the medical literature from January 1997 to May 2010 with the additional cases being identified by international regulatory agencies, scientific experts and breast implant manufacturers.
Since the 2011 report which provided a detailed analysis of the 34 cases was posted on the FDA website the FDA has continued to gather information about ALCL in women with breast implants.
From August 2010 to September 2015 the FDA received 258 medical device reports (MDR), including those in their original report, of ALCL in women with breast implants. There were three deaths. As the latest report points out: “Although the MDR system is a valuable source of information, it has limitations, including incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.”
However, the history of the use of breast implants in New Zealand would suggest that both the use of breast implants and the incidence of ALCL is likely to be much higher than what is officially reported.
For example, Medsafe, the NZ Medicines and Medical Devices Safety Authority, said only three cases of ALCL had been reported to it.
It is not known what causes the cancer, although one theory is that bacterial contamination is to blame.
For women whose disease is confined within the fibrous capsule that develops around the breast implant, the cancer can be successfully treated by removing the implants.
However, women who present with a mass “have a more aggressive clinical course that may be fatal justifying cytotoxic chemotherapy in addition to removal of the implants.”3
The New Zealand Association of Plastic Surgeons president, John Kenealy, was reported as saying that women with implants should examine their breasts for signs of swelling which is the most common symptom.
Swelling typically occurs “three to 14 years after the operation to insert the breast implant. This swelling is due to an accumulation of fluid. Breast implant-associated ALCL has been known to occur as soon as one year after the operation and as late as 37 years after the operation.”3
John Kenealy also maintained that surgeons discussed the benefits and risks of implants with their patients.
Given that surgeons are currently urging women not to panic, it is difficult to have much faith in either the information that surgeons give to women contemplating having breast implants or in the way that the risks are presented.
The information on the Medsafe website is also predictably reassuring:
“The Ministry of Health is advising anyone with breast implants concerned following an Australian report showing a slight increase in an already known rare risk of cancer that no immediate action need be taken if they are well.”4
It goes on to advise that Australia’s equivalent of Medsafe, the Therapeutic Goods Administration (TGA) will be undertaking a formal risk benefit review in 2017 and New Zealand has been invited to participate. Medsafe will be obtaining more information about the outcomes of the three cases in New Zealand and that information will be provided to the TGA to consider as part of the review.
References1. Radio NZ: NZ women affected by cancer linked to breast implants, 23 December 2016
2. US FDA: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
3. NZ Association of Plastic Surgeons: FAQs - Breast implant-associated ALCL
4. Medsafe: Breast implants and anaplastic large cell lymphoma - Information for Women with Breast Implants (since the original information was posted on the Medsafe website, two further posts have been added advising of additional confirmed cases of anaplastic large cell lymphoma)
In response to the letter the AWHC wrote to Medsafe, New Zealand Medicines and Medical Devices Safety Authority, about the problems with PIP breast implants in the wake of news that a number of New Zealand women had had them implanted, the Council has received a letter with the astonishing claim that these breast implants pose no more risks than any other brand of silicone gel-filled implant.
The scandal that broke at the end of last year centred on Poly Implant Prosthese (PIP), a leading inter-national manufacturer of silicone breast implants. The French implants were among the cheapest in the world and it was revealed they were filled with an industrial grade silicone. The implants had come under suspicion after doctors reported an abnormal number of rips and leaks in these particular implants.
According to Medsafe the doctors were wrong. “The failure rate (from a rupture or leak) for the PIP breast implants is around 0.4% for every year of implant and this comparable to other similar implants,” Stewart Jessamine, Medsafe’s group manager, wrote.
Tests by regulators in France, Australia and the UK and a sub-sequent review of the data by expert committees “has so far found no evidence of harm or toxicity associated with the filler used inside the PIP implants,“ he explained. “On this basis, the health risks from a PIP implant is no different from that of any other breast implant.”
However, the Medsafe website contains the following disclaimer to there being no evidence of harm:
“This reassurance should be cautioned by the limited level of knowledge at this stage.”1
It should be noted that Medsafe is not claiming that the PIP implants are safe. The letter simply points out that the risks are no greater than those for other brands, and that the risks of surgery to remove the implants may be greater than the risk posed by the PIP implants. “Removal of a PIP or any other breast implant is only recommended where a patient’s doctor/surgeon believes it necessary due to rupture or other health concern,” Stewart Jessamine wrote.
The message from Medsafe is that women must leave it to their doctor to make the decision about whether to have their implants removed, and it is not recommended that they do anything until the implant ruptures or something else happens.
History Repeats ItselfIt is of considerable concern that Medsafe is responding to the PIP breast implant issue as though it is a new problem.
Silicone breast implants were first marketed in 1963 by their inventors, the Dow Corning Corporation. It was decades before there were any regulations or testing to ascertain if they were safe. The US Food and Drug Administration (FDA) waited until 1992 to require manufacturers to prove that silicone implants were safe.
In the early 1990s, complaints began surfacing about serious illnesses women were experiencing as a result of their implants. The symptoms they described included numbness of their limbs, joint pains, rashes, chronic fatigue, migraines, loss of appetite, and diminished sex drive.
In January 1992, the FDA asked all surgeons to stop using silicone breast implants while they evaluated research to determine if there was a link between leaking silicone breast implants and diseases such as rheumatoid arthritis, scleroderma (a painful tightening and thickening of the skin) and rare auto-immune diseases. The New Zealand Department of Health gave New Zealand surgeons the same advice.
Dow Corning was then faced with a barrage of lawsuits for damages from its silicone breast implants. Women in NZ who had suffered problems as a result of leaking silicone were able to join the lawsuit and bring legal proceedings in the US.
In 1998, 410,000 women were awarded a $4.23 billion global settlement against Dow Corning. It took a further four to five years before some New Zealand women received their share of the settlement as a result of a class action by law firm Slater and Gordon for 2400 women, most of whom were from Australia, and even longer for another 1200 women in New Zealand who were represented by Michael Okkerse.
While the controversy continued about the link between silicone breast implants and the diseases that women were subsequently diagnosed with, there was never any doubt that breast implants did and still do have side effects.
One of the most serious and common complication is capsular contracture. This occurs when the body forms a thick layer of scar tissue around the implant. The tissue then hardens and contracts as the body attempts to isolate and remove the foreign body.
In 2000, the British Department of Health informed women considering implants that 10% of women suffer from contracture, “causing the implant to deform, become hard and, in some cases, painful.” In a severe contracture the breast is firm, hard, tender, painful, and cold. Distortion is marked. The US Institute of Medicine found that this severe form of capsular contracture affects not 10% of women but 100% of those who have had silicone implants for 25 years.2
Other side effects include red, thick, painful scars that can take several years to improve, painful nipples for three to six months following surgery, and the risk of the implant rupturing. All implants interfere with the ability of x-rays to detect the early signs of breast cancer by compressing the remaining breast tissue and impairing the ability to view changes.
Up to a quarter of women will have to have their implants replaced within five years, a rate that would not be regarded as acceptable in other devices.
Given the evidence that breast implants don’t work very well and often cause problems, why is Medsafe and the Ministry of Health not strongly advising women against them?
1. Originally referenced to http://www.health.govt.nz/news-media/news-items/pip-implant-advisory-and-frequently-asked-questions, but this page is no longer available. The current implant advice on the MoH website is here.
From the February 2007 AWHC Newsletter
From the November 2006 AWHC Newsletter
Eleven years after silicone breast implants were blocked for general use, an advisory panel to the US Food and Drug Administration (FDA) has recommended that they be allowed back on the market. A coalition of American women’s groups, including the National Organisation of Women (NOW) is leading the opposition.
In 1992 the FDA banned the use of silicone breast implants after concerns were raised that they were causing autoimmune disease. Saline implants remained on the market but the FDA requested new data on their safety and required 10 years of further studies.
The only two companies in the US that are still manufacturing breast implants are McGhan and Mentor. The latter company was criticised by the FDA committee for the small study population. Both companies reported that women required a second operation because a hard capsule had formed around the implant or because of leaks and deflation. For women who had had reconstruction following surgery for breast cancer, 43% of them had a second operation.
New Zealand Herald, 27 July 2002
After a decade of legal action the end is in sight for many New Zealand women who have been seeking compensation from breast implant manufacturer Dow Corning. It has been estimated that around 200,000 women worldwide have suffered a range of disorders including a variety of auto-immune disease as a result of having silicone breast implants.
The New Zealand women are part of a group of more than 2400 women, mainly from Australia, included in a class action by law firm Slater and Gordon which last year accepted a Dow Corning breast implant settlement of more that $47 million. Around 300 of these women are expecting to receive their payouts this month with the rest receiving their payments by the middle of the year. The women will receive lump-sum payments of up to $A50,000 each.
Another 1200 New Zealand women represented by Wellington lawyer Michael Okkerse are still waiting for their compensation payouts from Dow Corning. They had appealed against the payment plan approved by the US Bankruptcy Court, but a US court of appeal rejected this and other appeals at the end of January. This means these women are now closer to receiving their payments.
New Zealand Herald 1 February 2002.