The ruptured PIP breast implant

doi:10.1016/j.crad.2013.03.012

Clinical Radiology

Volume 68, Issue 8, August 2013, Pages 845-850

https://doi.org/10.1016/j.crad.2013.03.012 Get rights and content

Public concern erupted about the safety of Poly Implant Prothèse (PIP) breast implants when it was revealed in 2011 that they contained an inferior, unlicensed industrial-grade silicone associated with a high rate of rupture. There followed national guidance for UK clinicians, which led to a considerable increase in referrals of asymptomatic women for breast implant assessment. In this review we discuss possible approaches to screening the PIP cohort and the salient characteristics of a ruptured implant.

Introduction

The silicone Poly Implant Prothèse (PIP) breast implant (also marketed as M-Implants and Rofil-implants) were made in France from 2001 until their production ceased in March 2010.¹ It is estimated that in the UK about 47,000 women may have received a PIP implant,² the majority of which were implanted in the private sector. According to the analysis of the French authorities, the silicone contained in these implants was of an industrial standard, rather than the medical grade originally tested for the award of the CE mark of approval.³ Soon after their withdrawal from the French market, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a device alert advising clinicians not to use PIP implants. Six months later there followed advice from the MHRA that clinicians should contact all patients who received a PIP implant and offer them a specialist consultation and “appropriate investigation” of the implant. The media spotlight probably inflated legitimate concern amongst patients with a PIP implant4, 5, 6, 7, 8, 9, 10 and led to a greatly increased demand for implant screening and subsequent resource burden for the National Health Service (NHS).11, 12 The advice from MHRA concerning PIP implants is a significant departure from the usual approach to breast implant imaging. Until now, breast implants of any brand or construction have only been imaged in the context of symptoms.

Concerns have been raised about the construction of both the implant shell and its silicone filler.1, 13, 14 The filler of the PIP implant contains a higher proportion of low molecular weight silicone than would be found in a medical-grade product, and it is this that is thought to be the culprit in early shell weakening and rupture.³ Official chemical analysis has also revealed considerable variation in the structure of the silicone compound, such that implant performance may be somewhat unpredictable.³

Mammography and sonography have a role in implant assessment for symptomatic women.15, 16, 17, 18, 19, 20, 21, 22, 23 However, the superior sensitivity and specificity of magnetic resonance imaging (MRI) as compared to mammography or ultrasound for the detection of prosthetic failure makes it the reference standard imaging investigation.16, 18, 23, 24 MRI also offers the advantage of being able to image both breasts and the axillae at once without exposure to ionizing radiation (Table 1).

Section snippets

Features of implant rupture

Ruptures are generally considered either intra-capsular or extra-capsular. In the former, silicone gel is no longer contained by the implant shell but is retained within the fibrous capsule that normally forms in the breast following prosthetic implantation. Intra-capsular ruptures are often silent as breast shape is unchanged, the patient is asymptomatic, and clinical examination is unremarkable. Extra-capsular ruptures occur where free silicone gel leaks outside of the breast's fibrous

Magnetic resonance imaging

MRI gives the best illustration of the varying characteristics of the ruptured implant, indeed several of the signs are specific to this technique. Numerous radiological signs have been described relating to breast implant rupture on MRI, notably the “linguine”, “keyhole” or ”noose”, “salad oil”, and “sub-capsular line” signs.²⁴

The linguine sign is highly sensitive and specific for intra-capsular rupture (96% and 94%, respectively)¹⁵ and shows the collapsed walls of implant shell floating in

Ultrasound

Ultrasound is performed using a high-frequency (e.g., 12 MHz) linear-array probe. In many institutions the availability and cost of sonography make it an attractive first-line investigation of implant integrity.26, 27 Ultrasound also has the advantage of being able to reveal other unrelated breast disease. The ultrasound appearance of an intra-capsular rupture reflects MRI appearances. The linguine sign is again revealed as linear echogenic strands within the substance of the implant (Fig 1).

Mammography

Detection of extra-capsular implant ruptures can be difficult on mammography, and detection of intra-capsular silicone ruptures is often not possible (Fig 15). Furthermore, the compression required during mammography can exacerbate a pre-existing defect or convert an intra-capsular rupture to extra-capsular. For these reasons women may be unwilling to undergo mammography.

Conclusion

Although mammography and sonography have a role in assessing breast implants in symptomatic women, MRI is widely accepted as the reference standard. STIR and silicone-bright sequences are especially useful, and even when used in isolation and without contrast medium enhancement, provide high-quality and cost-effective images to assess implant integrity alone. Although there is a need for further data with surgical correlation, our experience to date suggests STIR and silicone-bright sequences

References (28)

T.S. Adams et al.
A late complication following the insertion of hydrogel breast implants
J Plast Reconstr Aesthet Surg
(2007)
R. Smith et al.
The implications of PIP are more than just cosmetic
Lancet
(2012)
M. Berry et al.
The PIP mammary prosthesis: a product recall study
J Plast Reconstr Aesthet Surg
(2012)
M. O'Toole et al.
Imaging spectrum of breast implant complications: mammography, ultrasound, and magnetic resonance imaging
Semin Ultrasound CT MR
(2000)
M.A. Carillon et al.
Breast implants and health alert PIP: experience of the regional cancer center of Lille
Bull Cancer
(2012)
Medicines Healthcare Products Regulatory Agency. Medical Device Alert, MDA/2012/011. Issued 15 March 2012. Department...
Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The Safety of PIP Silicone Breast...
A. O'Dowd
UK recommends PIP breast implants should not be removed
BMJ
(2011)
A. O'Dowd
French women to have PIP breast implants removed for free
BMJ
(2011)
A. O'Dowd
Additional 7000 UK women may have faulty PIP implants
BMJ
(2012)

A. O'Dowd

Around 1000 women with private sector PIP implants seek NHS help

BMJ

(2012)

A. O'Dowd

Government puts pressure on private sector to pay for removal of PIP breast implants

BMJ

(2012)

A. O'Dowd

UK launches inquiry into safety of PIP breast implants

BMJ

(2012 Jan 3)

I. Torjesen

Hundreds of thousands of pounds of NHS funds have been spent on care of private patients with PIP implants

BMJ

(2012)

Cited by (10)

Prevalence, clinical characteristics, and management of silicone lymphadenopathy: A systematic review of the literature
2024, Journal of Plastic, Reconstructive and Aesthetic Surgery
Implant-based breast augmentations and reconstructions are one of the most common surgical procedures performed by plastic surgeons in the United States, which has rapidly increased in popularity since the 2000s. Silicone lymphadenopathy (SL) is a complication of breast implants that involves migration of silicone to nearby soft tissue/lymph nodes. Data on its clinical features and management is scarce.
SL-related search terms were used to find articles in 3 databases. Of 598 articles, 101 studies met the inclusion criteria. Demographics, clinical presentation, workup, and management data were analyzed.
Of 279 cases of SL and 107 with information on initial diagnosis, 35 (33%) were incidental. The most common symptom was painless lymphadenopathy, followed by painful lymphadenopathy. 251 (95%) and 13 (5%) patients had silicone and saline implants, respectively. 149 (68%) patients had implant rupture. Axillary lymphadenopathy was the most affected region (136 cases, 72%), followed by internal mammary (40 cases, 21%), cervical/supraclavicular (36 cases, 19%), and mediastinal (24 cases, 13%) regions. 25% of patients underwent fine-needle aspiration, 12% core needle biopsy, and 59% excisional biopsy. 32% of cases underwent explantation and/or implant exchange. The most common indication for surgery was implant rupture. Histology showed multinucleated giant cells, large histiocytes, and silicone accumulation.
SL is a complication associated with breast implants. The majority of patients are asymptomatic, and most cases are managed conservatively. Minority need a biopsy and surgical interventions due to abnormal imaging, persistent symptoms, and/or implant rupture. Workup and management should be tailored to the patient.
ACR Appropriateness Criteria® Breast Implant Evaluation: 2023 Update
2023, Journal of the American College of Radiology
This document discusses the appropriate initial imaging in both asymptomatic and symptomatic patients with breast implants. For asymptomatic patients with saline implants, no imaging is recommended. If concern for rupture exists, ultrasound is usually appropriate though saline rupture is often clinically evident. The FDA recently recommended patients have an initial ultrasound or MRI examination 5 to 6 years after initial silicone implant surgery and then every 2 to 3 years thereafter. In a patient with unexplained axillary adenopathy with current or prior silicone breast implants, ultrasound and/or mammography are usually appropriate, depending on age. In a patient with concern for silicone implant rupture, ultrasound or MRI without contrast is usually appropriate. In the setting of a patient with breast implants and possible implant-associated anaplastic large cell lymphoma, ultrasound is usually appropriate as the initial imaging.
The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.
ACR Appropriateness Criteria <sup>®</sup> Breast Implant Evaluation
2018, Journal of the American College of Radiology
Citation Excerpt :
Most implant ruptures are intracapsular, and these are most often asymptomatic. MRI findings of both intracapsular and extracapsular rupture have been described [7,9,10,22,31]. An incomplete intracapsular rupture has been referred to by a variety of names including the “inverted-loop sign,” “keyhole sign,” “teardrop sign,” and “hang noose sign.”
Breast implant imaging varies depending on patient age, implant type, and symptoms. For asymptomatic patients (any age, any implant), imaging is not recommended. Rupture of saline implants is often clinically evident, as the saline is resorbed and there is a change in breast contour. With saline implants and equivocal clinical findings, ultrasound (US) is the examination of choice for patients less than 30 years of age, either mammography/digital breast tomosynthesis or US may be used for those 30 to 39 years of age, and mammography/digital breast tomosynthesis is used for those 40 years and older. For patients with suspected silicone implant complication, MRI without contrast or US is used for those less than 30 years of age; MRI without contrast, mammography/digital breast tomosynthesis, or US may be used for those 30 to 39 years of age; and MRI without contrast or mammography/digital breast tomosynthesis is used for those 40 years and older. Patients with unexplained axillary adenopathy and silicone implants (current or prior) are evaluated with axillary US. For patients 30 years and older, mammography/digital breast tomosynthesis is performed in conjunction with US. Last, patients with suspected breast implant–associated anaplastic large-cell lymphoma are first evaluated with US, regardless of age or implant type.
The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.
False-positive axillary lymph nodes due to silicone adenitis on <sup>18</sup>F-FDG PET/CT in an oncological setting
2016, Journal of Thoracic Oncology
Citation Excerpt :
In this case, given the context of an oncological diagnosis and increased 18F-FDG uptake in the contralateral axillary lymph nodes suggestive of nodal metastatic disease, a biopsy was performed and revealed silicone adenitis. This entity consists of inflammatory lymph nodes containing free silicone surrounded by inflammatory cells (most often macrophages), and in this case, it is due to silicone leakage from the breast implants as confirmed by morphological imaging.1–3 This case confirms previous reports that contralateral axillary lymph node involvement in the presence of an underlying lung carcinoma is rare.
The case of a 49-year-old transgender individual with a history of bilateral silicone breast implants and a right lung mass proven by biopsy to be a non–small cell lung cancer is presented. In addition to the primary malignancy, a positron emission tomography/computed tomography scan showed contralateral hypermetabolic adenopathy in the left axilla that was suggestive of nodal metastatic disease. Additional imaging and histological examination of the lymph nodes indicated silicone breast implant leakage and silicone adenitis as the underlying cause of the hypermetabolic axillary lymph node.
Diagnosing PIP breast implant failure: A prospective analysis of clinical and ultrasound accuracy
2015, Journal of Plastic, Reconstructive and Aesthetic Surgery
Citation Excerpt :
Any future study investigating the accuracy of ultrasound in PIP implants comparative to other brands would need to account for capsular contracture as a potential confounder. Our results are limited by the fact that ultrasound is user dependent.30 Not only is there a steep learning curve, but technical factors and suitability of equipment may also influence accuracy.10,31
The risk of Poly Implant Prosthesis (PIP) breast implant failure has been quantified by the Department of Health as 2–6 times greater than other brands. In the UK, removal of PIP breast implants is recommended when failure is suspected from patient history or clinical findings. Owing to conflicting reports of accuracy in current literature, ultrasound is not recommended as a routine investigation.
We aimed to evaluate the accuracy of patient history, clinical impression, and ultrasound at diagnosing implant failure in a large consecutive series of women against the reference standard. We aimed to provide evidence in response to current guidelines and help guide best practice.
All patients from January 2012–January 2013 who underwent PIP breast implant explantation at the Spire Murrayfield Hospital were prospectively evaluated. Operative findings were correlated to pre-operative results of patient history, clinical impression and ultrasound imaging. Sensitivity, specificity and accuracy were calculated with 95% confidence intervals.
A total of 192 women who underwent 384 PIP implant explantations from January 2012 to January 2013 were included. Twenty-three patients (12.0%) reported a positive patient history pre-operatively. In 35 patients (18%), failure was pre-operatively diagnosed clinically. Intra-operatively, 80 implants (21%) in 63 women (33%) had failed. The sensitivity of patient history, clinical impression and ultrasound was 12%, 34%, and 91%, respectively. The specificity was 88%, 89%, and 97%, respectively. Ultrasound was 96% accurate at diagnosing PIP implant failure, whilst patient history and clinical impression were 63% and 71% accurate, respectively.
Ultrasound provides a far more reliable test of implant failure than patient history or clinical impression. Considering the availability, cost and number of women in the UK with PIP implants, we would recommend high-resolution ultrasound be implemented as a routine investigation.
MR Evaluation of Breast Implants
2014, Radiologic Clinics of North America

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Pictorial ReviewThe ruptured PIP breast implant

Introduction

Section snippets

Features of implant rupture

Magnetic resonance imaging

Ultrasound

Mammography

Conclusion

J Plast Reconstr Aesthet Surg

Lancet

J Plast Reconstr Aesthet Surg

Semin Ultrasound CT MR

Bull Cancer

UK recommends PIP breast implants should not be removed

BMJ

French women to have PIP breast implants removed for free

BMJ

Additional 7000 UK women may have faulty PIP implants

BMJ

Around 1000 women with private sector PIP implants seek NHS help

BMJ

Government puts pressure on private sector to pay for removal of PIP breast implants

BMJ

UK launches inquiry into safety of PIP breast implants

BMJ

Hundreds of thousands of pounds of NHS funds have been spent on care of private patients with PIP implants

BMJ

Pictorial Review
The ruptured PIP breast implant