A voice for women's health

Breast Implants



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


See also Medical Devices
 

Breast Implants Linked to Cancer

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.

 
References
1. 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)


 

Medsafe’s Claims re PIP Breast Implants

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 Itself
It 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?

 
References

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.
2. Chambers, Clare, “Cosmetic Surgery, Culture, and Choice” in UK Feminista Thinkpiece series (2012).



Breast Implants Revisited


From the February 2012 AWHC Newsletter

Breast implants are once again at the centre of a major medical disaster story after it was revealed that implants manufactured by a French company contained a substandard, industrial grade silicone.

The history of breast implants is littered with flawed devices since silicone implants gained popularity in the early 1960s as a way of augmenting breast size.

The latest breast implant scandal is centred round Poly Implant Prothese (PIP), a leading international maker of breast implants founded by French entrepreneur Jean-Claude Mas. The implants were among the cheapest in the world, and were recently found to be filled with silicone made for mattresses rather than medical use.

Investigations began last year into the PIP which manufactured 100,000 breast implants a year and was exporting 80% of them. The implants came under suspicion after doctors reported an abnormal number of rips and leaks in the implants.

While regulators in Britain said tests had shown no evidence of a potential for cancer or chemical toxicity of the industrial grade silicone, and there was therefore no reason for their routine removal – now where have we heard that before? – both the French and German governments advised women to have them removed. Closer to home Australia’s medical watch dog agency, the Therapeutic Goods Administration (TGA) stated it would continue to investigate the situation over the coming months but did not believe there was enough evidence to warrant the removal of the implants. This despite the fact that round 8900 of the PIP implants had been used in Australian women, some of whom had complained about the devices splitting and leaking.

In New Zealand, the Ministry of Health said it had no record of any of the PIP breast implants being used, but whether they actually keep records of all breast implants used in New Zealand is far from clear.

Meanwhile, women with implants which include those recovering from breast cancer, report fearing that future ruptures could cause pain and inflammation as well as other problems resulting from the leakage of industrial silicone into their bodies.

 

Breast Implants Payouts

From the February 2007 AWHC Newsletter

After more than a decade of legal wrangling with breast implants manufacturer Dow Corning, 564 claims by New Zealand women damaged by the silicone breast implants have finally been settled. However, the sums received do not match those of American women, as overseas claimants, including the New Zealanders, were offered only 60% of the amount offered to the Americans because they were unable to sue in the USA
.
The New Zealand women appealed the decision to award them less but lost the case in 2002.
The 564 claimants were awarded amounts ranging between $NZ872 and $17,442. It is not known how many claims are still outstanding because some individuals had more than one claim.

As reported in the December 2006 issue of the AWHC newsletter, the USA Food and Drug Administration (FDA) recently gave approval for silicone breast implants to be sold again, 14 years after they were removed from the market because of concerns about their safety.

Silicone breast implants are available in New Zealand, but the Ministry of Health does not endorse their use and women must be warned of the risks before consenting to the cosmetic surgery. One study found that 69% of women with silicone implants had a rupture. 

 

 

FDA Lifts 14-Year Ban on Silicone Breast Implants

From the November 2006 AWHC Newsletter

On 17 November 2006 the American Food and Drug Agency (FDA) lifted its 14-year ban on the use of silicone gel breast implants in the United States after decades of contentious debate and legal action taken by thousands of women on their safety. The FDA has approved implants manufactured by two California companies, Mentor and Allergan, for breast reconstruction following breast cancer, trauma or developmental disorders affecting the chest, and for cosmetic breast augmentation, but it has limited cosmetic use of the implants to women aged 22 years and older.

Dr Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said the agency’s review, based on company-sponsored studies as well as long-term use of the implants abroad, had determined that their sale is in the best interests of women. He also warned that no device is foolproof and that there was a possibility that women would have to have the implants replaced at some point. Studies have shown that the majority of women with silicone implants would have a rupture at some point. According to the FDA one study found that 69% of women had a rupture.

Critics of FDA decision Meanwhile critics of the FDA’s decision have lambasted the agency and maintain the devices should not have been approved, and cited the same safety concerns that have been raised about the devices for years. Dr Sidney Wolfe, chief of the Public Citizen’s Health Research Group, called the implants “the most defective medical device ever approved by the FDA. The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety.’”

Amy Allina, program director at the National Women’s Health Network, also criticised the decision, saying that the FDA has approved the implants even though the manufacturers had failed to answer basic safety questions, such as exactly how long implants would last without rupturing, and whether there are health effects if silicone leaked out and traveled to other parts of the body.

Defending the decision to lift the ban Dr Schultz said that the FDA has been watching as the manufacturers collected data over the last 10 years and would require the companies to conduct post-approval studies involving a total of 80,000 women to continue monitoring the safety of the implants. He said that information would be collected about rates of rupture, cancer and autoimmune diseases and effects of the implants on reproduction.

But Ms Allina questioned the validity of such studies. “The FDA has no credibility to assert post-approval studies will be any better,” she said. “Once again the FDA is putting the interests of this administration’s allies, the economic interests of the industry, over public health.”

 

 

Silicone Implants

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.

But so far it’s good news for Inamed, which makes both saline and silicone implants. The company’s research data, based on only the first three years of a 10-year study, convinced the FDA committee that its latest silicone implants are safe enough for general usage. Critics still question whether the implants should be allowed on the market before the study is completed.

Encapsulated silicone-gel breast implants were developed in the 1960s, and the FDA began regulating them in 1976. After complaints that silicone leakage was causing illness, including connective tissue diseases, the FDA blocked the implants for anything but reconstruction in cancer patients and in clinical studies. Some women then turned to saline implants. When a saline implant ruptures, it is immediately apparent and simply releases salt water; silicone implant ruptures, on the other hand, according to the FDA can be gradual and go unnoticed while silicone migrates throughout the body.

Recent studies have purported to disprove silicone implants as the cause of cancer, immunological diseases or neurological problems. Inamed claims that the silicone devices are as good as or better than saline implants. However, Inamed’s data showed that, with silicone, 21% of augmentation patients and 46% of reconstruction patients required additional surgeries within three years because of complications or unsatisfactory cosmetic results.

In testimony to the panel, Dr Sidney Wolfe, director of Public Citizen’s Health Research Group, said that “precipitously” approving the devices would “amount to a massive experiment” on hundreds of thousands of women. Sybil Goldrich, who received silicone implants in the early 1980s after a double mastectomy, has called the situation “a horror movie.” Severe complications after her implant surgeries led her to form the Command Trust Network in 1988, which helped more than 150,000 claimants win a $4.3 billion settlement from Dow Corning, which manufactured the silicone implants.

The FDA did recommend that before getting implants, women sign an informed consent detailing risks.

Ms. magazine Winter 2003/04

 

Breast Implants Don't Last

The Food and Drug Administration (FDA) has recently ordered data on the failure rate of breast implants to be included in pamphlets given to women before surgery. Recent evidence presented to an FDA advisory committee revealed that up to a quarter of women having breast implants will require a replacement operation within five years. One of the committee members pointed out that such a high re-operation rate would not be acceptable in other types of prosthetic devices.

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


 

Breast Implant Compensation Payout

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.
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