A voice for women's health

Breast Implants


Update on Breast Implants and ALCL

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
 

Update on Breast Implants and ALCL

From the August September 2021 newsletter

Over the years breast implants have caused anxiety, anger, and a range of health problems for women who have had them for both cosmetic reasons and as part of breast reconstruction after breast cancer.

The most recent issue with breast implants in New Zealand is breast implant associated anaplastic large cell lymphoma, a rare type of non-Hodgkin’s lymphoma, a cancer of the lymphatic system.

The first discussion of ALCL in relation to breast implants in the medical literature came with the publication of a letter to the journal Plastic and Reconstructive Surgery, in August 1997.[1] The authors described the case of woman who had developed anaplastic T-cell lymphoma in proximity to a saline-filled breast implant.

In 2011, the US FDA became aware of a possible association between breast implants and the development of ALCL.[2] There were insufficient cases at the time for them to determine what factors increased the risk. In 2016, in their classification of lymphoid cancers, the World Health Organisation listed BIA-ALCL for the first time,[3] saying that it “usually presents as an accumulation of seroma fluid between the implant itself and the surrounding fibrous capsule” and that both “saline- and silicone-filled implants have been implicated, with a median interval from the time of the implant to the lymphoma of about 10 years.”

Srinivasa et al. found that, up to September 2015, there was limited information on BIA-ALCL, including incidence and risk, because of a lack of consistent and complete data on worldwide and country-specific total and textured implant sales, and incomplete or inadequate reporting on clinical history, treatment, and oncologic follow-up.[4]

Data collection and research is ongoing, and advice from regulatory authorities continues to evolve. As of October 2019, the US FDA advises:2

  • All patients who have breast implants or are thinking about getting them should be aware of the risk of BIA-ALCL.
  • The risk of BIA-ALCL is higher for textured surface implants compared with smooth surface implants.
  • Certain other textured breast products, specifically certain textured tissue expanders, should not be used.

While BIA-ALCL is generally described as rare in the medical literature, a very recent article in Plastic and Reconstructive Surgery found that “Recently published risk estimates for breast implant-associated anaplastic large cell lymphoma indicate that the incidence of BIA-ALCL may be much higher than previously understood, with a lifetime risk of one in 559 women with a textured device.”[5]

In 2019, Collect et al., in concluding their discussion of risk, wrote “Most striking is the exponential rise in incidence over the last decade”.[6] While their research was international, they said specifically that “recent data from Australia and New Zealand have revealed a dramatic rise in the frequency of diagnosis and incidence of BIA-ALCL. Fifty-six cases in total had been confirmed by 2017 with a subsequent 26 new cases of BIA-ALCL diagnosed between January 2017 and April 2018 representing a 47% increase in diagnosis.”

The conclusions of these papers are consistent with statements from Australia’s Therapeutic Goods Administration (TGA). In late 2016 they said that while “health authorities and surgeons had believed the risk was somewhere between one in three million and one in 50,000” the TGA “now estimated the risk ranged between one in 10,000 and one in 1000.”[7] At that time the Australian Broadcasting Corporation (ABC) reported that there had been 46 cases diagnosed in Australia and New Zealand.6

BIA-ALCL in New Zealand

BIA-ALCL was first brought to the attention of our readership in an article by Lynda Williams in 2017.[8] At the time, Lynda wrote:

“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.”

In contrast with regular reports on BIA-ALCL in Australia by their state broadcaster, since 2016 there has been a dearth of reports in New Zealand’s mainstream media. It would seem that, despite the fact that international health authorities have known since at least 2011 that breast implants can cause potentially fatal ALCL, women in New Zealand continued to receive implants that placed them at risk of ALCL and there has been little publicity or notification to those women that they may be at risk. Since 2016 when Radio NZ broke the story in the New Zealand mainstream media[9], it appears that concerns about BIA-ALCL have been downplayed by our health authorities.

In response to an Official Information Act (OIA) request from AWHC to the Ministry of Health and Medsafe in May this year, Medsafe advised that they “first published information on the potential for women with breast implants to develop BIA-ALCL in December 2016.” That information said that three cases had been reported to Medsafe.

The most recent Medsafe information was posted in several updates in 2019[10] advising:

  • On 11 April 2019 that “Regulatory Agencies around the world are investigating the safety of breast implants on the market following an increasing number of cases of anaplastic large cell lymphoma (ALCL) being reported,” and that Medsafe had received six adverse event reports where breast implant associated anaplastic large cell lymphoma has been diagnosed.
  • On 31 July 2019 that Device Technologies, supplier of Allergan textured implants in consultation with Medsafe had issued a recall of unused textured implants. The advice to women was that “Those who do not experience any changes or symptoms need take no action. Those who experience sudden, unexplained changes such as pain, lumps or swelling should see their general practitioner or the surgeon who carried out the breast implant surgery.” Medsafe restated that it had received only six adverse event reports for the implants.
  • On 17 November 2019 the Australian regulator, the TGA, “had decided to take regulatory action in relation to all un-implanted breast implants and tissue expanders sold in Australia.” This included removal of some implants from the register and a six-month suspension on supply of other implants pending review of further safety and performance. Suppliers advised Medsafe that those implants that could no longer be supplied in Australia, would also no longer be supplied in New Zealand. Medsafe advised that for available breast implants, newly imposed conditions of supply included a patient information leaflet and updated instructions for use to include the risk of BIA-ALCL, and the requirement for prompt reporting of adverse events to Medsafe.

A number of concerns arise from the Medsafe website information. First, the discrepancy between the officially reported numbers of cases of BIA-ALCL in New Zealand: Medsafe reported only six in April and July 2019, yet in 2016 RadioNZ reported ten. Adverse event reporting is a passive, voluntary system, so it would appear that there are cases in New Zealand for whom an adverse event was never formally reported. One women AWHC spoke to was told by her surgeon in 2019 that she was the 16th patient who had been diagnosed with BIA-ALCL, three times as many cases as Medsafe is currently officially aware of.

Second, their advice to women with Allergan textured implants was very lacklustre. ALCL is potentially fatal, yet there was no advice to surgeons to advise past recipients of the implants to get them checked or removed or even to keep an eye on possible symptoms. However, the symptoms are vague and not particularly conclusive – pain, lumps or swelling – many women suffer from pain, lumps and swelling in their breasts for a range of reasons not least of which are associated with their menstrual cycle, and tenderness, enlargement and lumpiness is common premenstrually. Therefore, it would be difficult for women to recognise the signs and symptoms as specifically being caused by BIA-ALCL.

Finally, Medsafe is not the “go to” source for health information for most people. Many New Zealanders would not know of Medsafe’s existence and Medsafe would almost certainly not be the place that people would seek advice or information if they had concerns. Without a directive to GPs and plastic surgeons to actively follow-up with women who had these breast implants, women might go for months or years with vague, non-specific symptoms completely unaware of the potential danger they were in.

In the OIA request, AWHC asked the Ministry of Health “Does the MoH have any information on breast implants and ALCL on its website and if so, why does it not appear in a search of the website? If not, why not, given that the MoH website is an important source of information for consumers?”

Medsafe replied that they were “currently in the process of creating a section in the Medical Devices tab on its website, similar to that for surgical mesh implants, specifically for breast implants,” and that “There is information on the Ministry of Health website on breast implants, and this includes links to the Medsafe website.”

However, on the MoH website[11] there is no mention of BIA-ALCL, there is one link to the Medsafe website at the bottom of the section titled “What are breast implant risks?” The predominant information is on breast implant rupture, and the only mention of cancer (no specific mention of ALCL) states: “There have been concerns that implants may increase the risks of some diseases including cancer and connective tissue diseases; however, the generally accepted view is that these are no more common in women with breast implants than in women without implants.”

The link to the Medsafe website on the MoH website takes you to a page on Silicone Gel Breast Implants[12]. Halfway down the page is a section on cancer which states:

“Another question is whether the silicone in breast implants can increase the risk of cancer. There is no evidence that this is the case, although the possibility cannot be totally ruled out. Studies presently under way should provide an answer to this question within the next few years.”

There is no mention of ALCL on this page. In fact, if you search for ALCL, BIA-ALCL or anaplastic large cell lymphoma on the MoH website you get no results at all.

It is completely disingenuous of Medsafe to say that those looking for information about BIA-ALCL on the MoH website are directed to that information on the Medsafe website. It is completely untrue and, in fact the information that people are directed to specifically says that there is no evidence of a link between breast implants and cancer. This Medsafe webpage is shockingly out of date and has not been revised since May 2013!

The only way to find information about BIA-ALCL on the Medsafe website is if you know what you are looking for. If you have breast implants and symptoms, unless you are very well read, know someone who knows about BIA-ALCL or have come across one of the very few media articles on BIA-ALCL, you have no idea what to look for.

Should Your Plastic Surgeon Advise You About BIA-ALCL?

The short answer is yes, but it is unclear how many, if any, women have actually been told about the issue.

One woman’s surgeon told her that they were not advising women with Allergan textured implants about the risk of BIA-ALCL because it was so rare; they didn’t want to be inundated with women wanting their implants removed, and were advising women only if they came in for check-ups.

While their website is out of date, Medsafe has at least recognised that BIA-ALCL is a disease that requires further action. In March 2020 the manufacturer of the breast implants at the centre of this issue – Allergan and Device Technologies – under a directive from Medsafe, sent a letter to all providers (e.g. plastic surgeons) of a range of BRST and Natrelle Allergan breast implants. The letter stated:

“It is required by Medsafe that all providers and patients of this product are notified of the health risks associated with the BRSTand NATRELLE® Breast Implants. These products carry a risk of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). As a provider of this product you will be required to notify these risks to all patients. It is also recommended that the patient be advised to ensure they schedule regular follow-up appointments with their chosen health care provider.”

It also advised surgeons that they were “alerted to this issue and requested to review the relevant literature in the context of their particular patients on a case-by-case basis.”

It was with some concern that a visit to the website of the New Zealand Association of Plastic Surgeons (NZAPS)[13] revealed that the most recent advice or information about BIA-ALCL is dated 19 May 2019 predating the Allergan/Device Technologies letter by almost a year. Under the News and Issues tab on their website, the most recent item on BIA-ALCL is dated September 2019, again predating the Allergan/Device Technologies letter by six months.

Worse still, their position statement on BIA-ALCL is dated September 2016. The information in the position statement is accurate… for 2016. The problem is that there has been a significant volume of research on BIA-ALCL published in the medical literature since 2016. Of particular importance is that there is now a lot more data of the degree of risk, and as we have already discovered, “risk estimates for breast implant-associated anaplastic large cell lymphoma indicate that the incidence of BIA-ALCL may be much higher than previously understood”.5

We have written to the NZAPS and asked if and when they plan to update their website with more current information on BIA-ALCL, and if they are aware if their members have complied with the directive to advise patients with these implants of their risk and what they should do? At the time of going to press we had still not had a response from them.

In Australia there has been a considerable amount of discussion about BIA-ALCL in the mainstream media, particularly in stories from the Australian Broadcasting Authority, which has broadcast or published at least 18 stories on breast implants and ALCL since December 2016. However, in New Zealand there has been very few stories about this in the mainstream media. Therefore, New Zealand women are almost entirely dependent on their surgeons to provide advice on the risk of BIA-ALCL and facilitate them making informed decisions about their health.

What Now for New Zealand Women?

Women with breast implants should seek advice from their health care provider, either their GP or plastic surgeon/surgeon who did their breast implant surgery. This advice will enable them to make an informed decision about how to proceed. It may not be necessary for them to have their implants removed but Medsafe advise that women with breast implants should have regular follow up exams.

Importantly, irrespective of what sort of implants women have, if they experience sudden, unexplained changes such as lumps or swelling in the breast, pain or tenderness, other than what they normally experience during their menstrual cycle (symptoms that are transient and temporary and associated with premenstrual changes), they should see their health care provider.

If a woman is diagnosed with BIA-ALCL, she should ensure that she or her surgeon lodges a report with Medsafe. It is impossible for our regulatory authorities to gain an adequate understanding of the incidence of BIA-ALCL if they are not advised when patients are diagnosed.

In their response to our requests for information, Medsafe said they had only eight reports of BIA-ALCL and several of those were duplicates, suggesting that reports had been lodged for only four women.

BIA-ALCL is effectively a treatment injury, arising as a result of medical treatment, and as such it may be appropriate to lodge a claim with ACC. We requested information from ACC on the number of claims made for BIA-ALCL and were advised:

“There are fewer than four accepted claims for anaplastic large cell lymphoma related to breast implants. There is no indication from the available claim information that any breast implant injuries relate to Allergan specific breast implants. Due to privacy reasons, the associated cost information cannot be provided.”

The Health and Disability Commissioner advised that a search of the detailed description field of complaints, found no complaints received by HDC about a diagnosis of ALCL arising from breast implants or of a diagnosis of ALCL arising from Allergan breast implants between 1 January 2011 and 14 June 2021.

 

 

[1] Keech JA and Creech JB, 1997: Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant, Plastic and Reconstructive Surgery, August 1997, 100 (2): 554.

[2] FDA, 2019: Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), US Food and Drug Administration, updated on 23 October 2019, accessed at https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl

[3] Swerdlow SH, et al., 2016: The 2016 revision of the World Health Organization classification of lymphoid neoplasms, Blood, May 19 2016; 127(20): 2375–2390.

[4] Srinivasa D, et al., 2017: Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases, Plastic and Reconstructive Surgery, 2017 May; 139(5): 1029-1039.

[5] Dabic S, et al., 2021: 26 Years of Textured Implants and BIA-ALCL: Continued Vigilance and Counseling Are Warranted, Plastic and Reconstructive Surgery, September 2021; 148 (3): 517e-518e.

[6] Collett DJ, et al., 2019: Current Risk Estimate of Breast Implant–Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants, Plastic and Reconstructive Surgery, March 2019; 143 (3S): 30S-40S.

[7] Scott S and Armitage R, 2016: Breast implant cancer much more common than previously thought, ABC, 21 December 2016, accessed at https://www.abc.net.au/news/2016-12-21/breast-implant-cancer-much-more-common-than-previously-thought/8136286

[8] Williams L, 2017: Breast Implants Linked to Cancer, Auckland Women’s Health Council Newsletter February 2017, accessed at https://www.womenshealthcouncil.org.nz/site/aklwhc/FEBRUARY%202017.pdf

[9] RNZ, 2016: NZ women affected by cancer linked to breast implants, Radio New Zealand, 23 December 2016, accessed at https://www.rnz.co.nz/news/national/321096/nz-women-affected-by-cancer-linked-to-breast-implants

[10] Medsafe, 2019: Breast Implants and anaplastic large cell lymphoma, Safety Information Monitoring Communication, updated 12 November 2019, accessed at http://www.medsafe.govt.nz/safety/Alerts/BreastImplants.asp


 

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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