6.1. Risk of ruptureRupture is a recognised complication of all breast implants. Ruptures of breast implants can be either intra-capsular, where the gel is confined within the fibrous capsule that the body forms around the implant, or extra-capsular, where the gel has extended into the breast or other localised tissues(14).
The risk of rupture of a breast implant increases over time, which means that the longer a woman has breast implants the more likely she is to experience a rupture.
Estimates of the frequency of breast implant rupture are variable. A report published by the FDA in June 2011(15) provides an updated analysis of ongoing pre and post market studies being conducted by the two sponsors of silicone gel filled breast implants in the USA (Allergan and Mentor). For Allergan implants, the cumulative MRI-diagnosed rupture rates were 0.5% after two years rising to 10.1% (primary augmentation) after 10 years, and for Mentor implants a rate of 1% at three years rose to 13.6% at eight years (primary augmentation).
Holmich et al prospectively followed up a group of women who had an intact breast implant confirmed on a baseline MRI(16). At the end of two years, there were definite ruptures in 10% of implants giving an overall rupture incidence rate of 5.3 ruptures/100 implants per year. Using this data they estimated that approximately 2% of implants would be ruptured by five years and 15-17% by 10 years.
There are no complete registry data available to provide information on the rate of rupture for PIP implants.
As of 12 April 2012, the TGA had received 288 reports of rupture of PIP breast implants of which 250 were confirmed, 38 were unconfirmed due to insufficient information to uniquely identify the patient, the implant used to verify that rupture has occurred.*
6.2. Diagnosis and investigationRupture of a silicone breast implant, or leaks of gel, can be associated with lumpiness or swelling in the breast or axilla (armpit), a change in the size, shape or feel of the breast, or redness, pain or tenderness.
About 50% of women who have a rupture may not experience any signs or symptoms that this has occurred(17).
Different imaging methods can identify the integrity of breast implants and also the extent of possible silicone leakage into adjacent tissues. MRI is regarded as the imaging study of choice for the assessment of silicone implant rupture as it has been shown to have the highest sensitivity and specificity compared with other imaging methods such as ultrasound(18). MRI has the ability to image the entire surface of the implant and surrounding tissue, however its diagnostic performance is far better when used in patients who have symptoms of rupture than in patients who do not(19).
Breast MRI is generally regarded as a safe procedure but not all patients are able to undergo MRI because of cardiac pacemakers, aneurysm clips or other metallic foreign bodies not compatible with MRI. Some patients are very claustrophobic and cannot complete a MRI examination. The risk of claustrophobia is less with breast MRI than with conventional MRI, however, because a dedicated breast coil is used. The use of intravenous contrast is not required for breast MRI when used for the assessment of breast implant rupture.
Ultrasound can be a useful technique for the evaluation of implant integrity in those who cannot have a MRI. Ultrasound is not as accurate as MRI in identifying rupture and is heavily dependent on the experience of the technician performing and interpreting the ultrasound(18). While ultrasound is good in identifying ruptures originating from the front wall of an implant, it is poor at visualising rupture originating from the back wall of the implant.
Women who know they have a PIP breast implant, or where clinical advice is that they might have, can access a Medicare rebate for a MRI to assess the integrity of their implant/s. The listing of this Medicare item follows independent expert advice from the Medical Services Advisory Committee. The rebate is available for MRIs performed from Monday, 12 March 2012, for a 12-month period. Further details for patients, health care practitioners and diagnostic imaging providers can be found at http://www.health.gov.au/internet/main/publishing.nsf/Content/di-mri-pip.
6.3. Health consequencesRupture of silicone gel filled breast implants, or leaks of gel, may result in the formation of lumps in the breast around the implant, or the gel may migrate to nearby tissues such as the chest wall or through the lymphatic system causing swollen lymph nodes (lymphadenopathy), most commonly of the axilla (armpit)(20-21). These lumps may cause swelling and discomfort or pain. The formation of silicone inflammatory reactions (granulomata) has been reported, and which in rare cases has required surgical removal of large amounts of tissue(22).
One study has attempted to look at the possible health implications over time of ruptured silicone breast implants that remained untreated(23). This Danish study followed 64 women with 96 MRI diagnosed ruptured implants who did not have symptoms that warranted surgical removal (explantation). A repeat MRI at two years identified that 11 implants (11%) in 10 women had signs of progression (moving from intra to extra capsular rupture or increasing extracapsular silicone spread), but all changes were considered minor.
It has previously been hypothesized that an increased exposure to silicone from ruptured implants may lead to more general ill health with systemic symptoms, such as those that occur with connective tissue disease (for example, systemic lupus erythematosus and rheumatoid arthritis). There is consistent epidemiological evidence from published large-scale studies as well as meta-analyses which conclude there is no evidence of an association between silicone breast implants and connective tissue diseases. This assessment is supported by the FDA(15) and the recently released report on the safety of PIP Silicone Breast Implants by the European Commission’s Scientific Committee(2).
There is a small number of case reports of PIP breast implant rupture in the literature. These describe local breast inflammatory and fibrotic changes, and in one case silicone migration causing swollen lymph nodes (lymphadenopathy) and skin changes(24-26). From the information available there appears to have been no long-term effects on health in these cases(1).
6.4 Explantation (surgical removal)The risk of explantation can be considered in two groups: the risk associated with the anaesthesia, and the risk of complications from the breast surgery.
Many women with breast implants are healthy with no or few other health problems (co-morbidity)(2). For a healthy patient undergoing general anaesthesia, the risk of death and serious complications is very low, with the Australian and New Zealand College of Anaesthetists advising that the risk of death is approximately 1 in 100,000(27). Further, all women with breast implants will have previously undergone at least one general anaesthetic which improves the ability to individualise an assessment of risk based on this past experience(2).
Local complications are more common and can occur immediately after surgery or appear months or years later. Immediate complications include infection and bleeding. More delayed complications include capsular contracture, unequal breast shape (asymmetry), wrinkling, scarring, rupture and reoperation. Complications are higher in women who have implantations for reconstructive surgery after mastectomy than augmentation (enlargement)(28-29). This is due to multiple factors including prior tissue damage from chemotherapy and/or radiotherapy, related surgical trauma of mastectomy and amount of tissue available(2).
The risk of delayed complications appears to be greater in revision (second or subsequent) surgeries compared with the primary or initial surgery(2). Table 2 shows some of the findings from an FDA analysis of cumulative incidence rates of complications for those undergoing a primary augmentation and a secondary (revision) augmentation procedure for two types of silicone breast implants in the US. The tables listing all complications from the FDA analysis are included at appendix B. Top of page
Table 2: Core Study complications over 10 and 8 years for Allergan and Mentor silicone gel-filled breast implant patients. Table shows cumulative incidence rates over time.
|Allergan brand (cumulative incidence over 10 years)||Mentor brand (cumulative incidence over 8 years)|
|Complication||Primary Augmentation||Revision Augmentation||Primary Augmentation||Revision Augmentation|
|Capsular contracture (Baker III/IV)||19.1%||27.5%||10.9%||24.1%|
The surgical removal of breast implants may be more difficult if they are ruptured, and if there is associated inflammation surrounding the implant. In the longer term, inflammation may lead to the formation of fibrous or scar tissue. Most surgeons recommend removal of ruptured breast implants(2), particularly for extra-capsular rupture, but do not regard the need for this surgery as urgent.
An important consideration for women considering explantation surgery is whether they should have their implants replaced. Women who do not have them replaced may have cosmetically undesirable dimpling, puckering, or sagging of the natural breast following implant removal. As discussed above, if replacement with new implants is undertaken there is a likely increased risk of delayed complications such as contracture, rupture, implant removal and reoperation associated with revision (or subsequent) surgeries when compared with the primary surgery.
6.5 Surgeon experienceSome surgeons in Australia have raised concerns about higher rupture rates in PIP silicone breast implants. British surgeons, in their joint surgical guidance statement, state that "reports have suggested that in cases of PIP implant rupture/leak the inflammatory reaction may be more intense than usual…"(31). Similar anecdotal reports have been raised during discussions with Australian surgeons, and include the appearance of the implant at the time of removal (such as loss of integrity of the shell, the silicone appearing clumped) and evidence of fluid around the implant.
The TGA is attempting to collect this important information by sending a questionnaire to all surgeons who report a rupture of a PIP breast implant to the TGA. By 5 April 2012 the TGA had forwarded 102 surgeon questionnaires, with 27 completed forms returned (26.4%). The level of detail provided in the returned questionnaires has been variable, and combined with the current low rate of return, it is not possible to determine the extent of these implant changes or experiences in the Australian population at this stage.
6.6. Consumer ExperienceConsumers have provided reports to the TGA on their experience with PIP breast implants. These reports are on local breast implant complications such as rupture and contractures, and anxiety and distress. A number of the consumer reports also described the consumer experiencing systemic symptom/s, such as fatigue, general malaise, hair loss and headaches, which are reported to be associated with their implant. The TGA is seeking consent from these individuals to contact their treating doctor to gain further information on the nature of their symptoms, and the results of any investigations.
Systemic or general symptoms, such as fatigue and headache, may be experienced as part of many different health conditions. It is important that women experiencing these symptoms visit their medical practitioner so that a personalised review can be carried out to exclude other underlying conditions.
6.7. Medicare rebateNormal Medicare arrangements apply to reimbursing patients for the usual cost of medical services related to managing health concerns about their PIP implants.
This includes Medicare rebates related to:
- consultations with their GP or surgeon
- imaging via ultrasound or MRI (as per section 6.2, for 12 months from March 12th 2012)
- surgery - the removal and replacement of breast implants under certain conditions.
These rebates do not cover private hospital accommodation, private hospital theatre costs, or the cost of replacement breast implants. Private health insurance may contribute to accommodation and theatre costs in private hospitals, and the replacement implant under some policies.
Women may elect to be treated through the public hospital system. Subject to local arrangements, their medical practitioner can refer them to the nearest appropriate public hospital or to a surgeon who provides public hospital services, who will then be able to assess and advise on the best course of action in consultation with the patient.
* This data was amended on 10 May 2012 and updated in this document.Top of page