- Email: [email protected]
Bilateral supraclavicular swelling: An unusual presentation of ruptured Poly Implant Prosthese (PIP) breast implants
Journal of Plastic, Reconstructive & Aesthetic Surgery (2013) 66, 267e269
CASE REPORT
Bilateral supraclavicular swelling: An unusual presentation of ruptured Poly Implant Prosthese (PIP) breast implants* Tharjan Manickavasagar*, Andrew N. Morritt, Graham J. Offer The Department of Plastic Surgery, Leicester Royal Infirmary, Leicester LE1 5WW, UK Received 15 April 2012; accepted 11 June 2012
KEYWORDS PIP breast implant; Supraclavicular swelling; Ruptured breast implant; Lymphadenopathy; Siliconoma
Summary Breast implants manufactured by the French company Poly Implant Prosthese (PIP) have gained notoriety in the International media since the realisation that industrial grade silicone was used in their manufacture with consequent increased risk of implant rupture. At present, it is estimated that there are estimated to be over 40,000 women in the UK with PIP implants. We report an unusual presentation of PIP breast implant rupture as swelling in the supraclavicular fossae. This has not previously been reported in the literature. ª 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Case report A 39 year old woman presented with bilateral supraclavicular fullness. She underwent an investigative MRI scan to her neck. This revealed bilateral axillary * This Case Report had been accepted as a Poster Presentation at the British Association of Plastic Reconstructive and Aesthetic Surgeons Summer Meeting, 11e13 July, 2012. * Corresponding author. Tel.: þ44 116 258 5786; fax: þ44 116 258 5852. E-mail address: [email protected] (T. Manickavasagar).
lymphadenopathy with multiple large lymph nodes causing a pressure effect on the supraclavicular fossae contents. Bilateral breast implant rupture and siliconomas within the breasts were also noted. The patient then admitted to having undergone 11 years previously, pre-pectoral breast augmentation with PIP implants. Breast examination revealed bilateral Baker grade 2 capsule formation and axillary lymph node swelling. She underwent bilateral total capsulectomies, removal of ruptured PIP implants (Figure 1) and siliconomas and axillary lymphadenectomies (Levels 1e3) (Figure 2). Over the course of next three months, she developed three seromas that were drained using needle aspiration.
1748-6815/$ - see front matter ª 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.bjps.2012.06.018
268
T. Manickavasagar et al.
Figure 1
The ruptured PIP breast implants.
Histology showed reactive lymphadenopathy presumed to be secondary to silicone. The lymph nodes ranged in size from 5 to 45 mm in maximum dimension. Empty spaces are apparent in fat adjacent to lymph nodes (Figure 3) indicative of extranodal, silicone deposition (silicone is lost during processing, so the implication is that empty spaces are where the silicone would have been).
Discussion Regional lymphadenopathy in response to ruptured silicone gel filled breast implants has been reported since the first implants were used.1 Mechanical testing of the PIP implants demonstrated that the implants were more susceptible to rupture and more of an irritant potential in contrast to the conventional silicone implants.2 In our case, the senior author noted that the enlarged lymph nodes were far greater in size than in any other case that he had seen in patients with non-PIP breast implants. The Medicines and Healthcare Regulatory Agency (MHRA) in March 2010 issued a medical device alert to suspend the marketing, distribution and export and use of silicone gel filled implants manufactured by the French company Poly Implant Prosthese (PIP) due to the use of
Figure 2
Axillary lymphadenectomy specimen.
non-approved silicone as advised by the French regulatory authority Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPs).3 Recently following the death of a woman from anaplastic large cell lymphoma (ALCL) in France, the French government have advocated the removal of all PIP implants from women. In contrast, the MHRA in the UK does not advocate the routine removal of implants as there is no evidence of increased risk of cancer in patients with PIP implants based on MHRA independent investigations.4 De Jong et al. stated that there is a very rare association of 1 in a million between ALCL and breast implants but not a causal link.5 Furthermore breast-associated ALCL occurred rarely in women with and without breast implants and no type of implant was attributed to ALCL.6 Epidemiological reviews have also concluded that there is not an increased risk of ALCL in patients with breast implants.7,8 An expert review group with representatives from Association of Breast Surgery, the British Association of Plastic and Reconstructive Aesthetic Surgeons, the British Association of Aesthetic Plastic Surgeons, the Federation of Surgical Speciality Associations and the Royal College of Surgeons have advised surgeons to remove PIP implants if requested by the patient or if there is evidence of implant
Figure 3
Representative histology from siliconoma.
PIP breast implants leak or rupture. Symptoms suggestive of implant rupture include change in breast shape, hardening, tenderness or lumpiness of the breast and or regional swelling of the lymph nodes.9 There are thought to be over 40,000 women in the UK whom have been implanted with PIP breast implants.10 The impending increase in the incidence of patients presenting with ruptured PIP implants is a problem that General Practitioners and Plastic Surgeons will encounter. The questions arising at this stage are ‘what is the risk of rupture and siliconoma formation in patients with PIP implants’? Also, does the relatively small risk of surgery to remove intact implants outweigh the risk of implant rupture and siliconoma formation requiring more extensive and higher risk surgery? We advocate that ruptured implants should be a differential diagnosis of supraclavicular fullness in a woman with PIP breast implants. We also recommend that all Surgeons continue to report problems that patients develop with PIP implants to the MHRA via their website reporting service. This will empower the MHRA to decide if all PIP implants should be removed.
Conclusion We report this case to highlight an atypical presentation of PIP implant rupture with extensive lymph node enlargement.
Conflict of interest/funding None.
Acknowledgements Ms Rajshree Jayarajan (Clinical Fellow in Plastic Surgery, Leicester Royal Infirmary) provided the photographic images of the operative specimens.
269 Dr Esme Pointen (Consultant Histopathologist, Leicester Royal Infirmary) provided the images of the histology slides of the operative specimens.
References 1. Wintsch W, Smahel J, Clodius L. Local and regional lymph node response to ruptured gel-filled mammary prostheses. Br J Plast Surg 1978;31:349e52. 2. Tests effectue ´s sur les prothe `ses mammaires en gel de silicone PIP 28.09.2010 AFSSAPs. http://www.afssaps.fr/Dossiersthematiques/Implants-mammaires-PIP-pre-remplis-de-gel-desilicone/Tests-effectues-sur-les-protheses-mammaires-en-gelde-silicone-PIP/(offset)/3. [Accessed 14.03.12]. 3. MHRA Medical Device Alert 31 March 2010: Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP) e all models and lot numbers (MDA/2010/025). http://www. mhra.gov.uk/home/groups/dts-bs/documents/ medicaldevicealert/con076500.pdf. [Accessed 14.03.12]. 4. MHRA Press release 23 December 2011: Poly Implant Prosthese (PIP) breast implants update. http://www.mhra.gov.uk/ NewsCentre/Pressreleases/CON137935. [Accessed 14.03.12]. 5. de Jong D, Vasmel WL, de Boer JP, et al. Anaplastic large-cell lymphoma in women with breast implants. J Am Med Assoc 2008;300:2030e5. 6. Jewell M, Spear SL, Largent J, et al. Anaplastic large T-cell lymphoma and breast implants: a review of the literature. Plast Reconstr Surg 2011;128:651e61. 7. Lipworth L, Tarone RE, McLaughlin JK. Breast implants and lymphoma risk: a review of the epidemiologic evidence through 2008. Plast Reconstr Surg 2009 Mar;123:790e3. 8. Deapen D. Breast implants and breast cancer: a review of incidence, detection, mortality, and survival. Plast Reconstr Surg 2007 Dec;120(7 Suppl. 1):70Se80S. 9. Poly Implant Prosthese PIP breast Implants. Joint surgical statement on clinical guidance for patients, GPs and surgeons. Royal College of Surgeons of England, http://www.rcseng.ac. uk/publications/docs/pip-statement/?searchtermZPIP; January 2012 [Accessed 14.03.12]. 10. MHRA Press release 21 April 2011: French regulator confirms non-toxicity of PIP breast implants. http://www.mhra.gov.uk/ NewsCentre/Pressreleases/CON114614. [Accessed 14.03.12].
CASE REPORT
Bilateral supraclavicular swelling: An unusual presentation of ruptured Poly Implant Prosthese (PIP) breast implants* Tharjan Manickavasagar*, Andrew N. Morritt, Graham J. Offer The Department of Plastic Surgery, Leicester Royal Infirmary, Leicester LE1 5WW, UK Received 15 April 2012; accepted 11 June 2012
KEYWORDS PIP breast implant; Supraclavicular swelling; Ruptured breast implant; Lymphadenopathy; Siliconoma
Summary Breast implants manufactured by the French company Poly Implant Prosthese (PIP) have gained notoriety in the International media since the realisation that industrial grade silicone was used in their manufacture with consequent increased risk of implant rupture. At present, it is estimated that there are estimated to be over 40,000 women in the UK with PIP implants. We report an unusual presentation of PIP breast implant rupture as swelling in the supraclavicular fossae. This has not previously been reported in the literature. ª 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Case report A 39 year old woman presented with bilateral supraclavicular fullness. She underwent an investigative MRI scan to her neck. This revealed bilateral axillary * This Case Report had been accepted as a Poster Presentation at the British Association of Plastic Reconstructive and Aesthetic Surgeons Summer Meeting, 11e13 July, 2012. * Corresponding author. Tel.: þ44 116 258 5786; fax: þ44 116 258 5852. E-mail address: [email protected] (T. Manickavasagar).
lymphadenopathy with multiple large lymph nodes causing a pressure effect on the supraclavicular fossae contents. Bilateral breast implant rupture and siliconomas within the breasts were also noted. The patient then admitted to having undergone 11 years previously, pre-pectoral breast augmentation with PIP implants. Breast examination revealed bilateral Baker grade 2 capsule formation and axillary lymph node swelling. She underwent bilateral total capsulectomies, removal of ruptured PIP implants (Figure 1) and siliconomas and axillary lymphadenectomies (Levels 1e3) (Figure 2). Over the course of next three months, she developed three seromas that were drained using needle aspiration.
1748-6815/$ - see front matter ª 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.bjps.2012.06.018
268
T. Manickavasagar et al.
Figure 1
The ruptured PIP breast implants.
Histology showed reactive lymphadenopathy presumed to be secondary to silicone. The lymph nodes ranged in size from 5 to 45 mm in maximum dimension. Empty spaces are apparent in fat adjacent to lymph nodes (Figure 3) indicative of extranodal, silicone deposition (silicone is lost during processing, so the implication is that empty spaces are where the silicone would have been).
Discussion Regional lymphadenopathy in response to ruptured silicone gel filled breast implants has been reported since the first implants were used.1 Mechanical testing of the PIP implants demonstrated that the implants were more susceptible to rupture and more of an irritant potential in contrast to the conventional silicone implants.2 In our case, the senior author noted that the enlarged lymph nodes were far greater in size than in any other case that he had seen in patients with non-PIP breast implants. The Medicines and Healthcare Regulatory Agency (MHRA) in March 2010 issued a medical device alert to suspend the marketing, distribution and export and use of silicone gel filled implants manufactured by the French company Poly Implant Prosthese (PIP) due to the use of
Figure 2
Axillary lymphadenectomy specimen.
non-approved silicone as advised by the French regulatory authority Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPs).3 Recently following the death of a woman from anaplastic large cell lymphoma (ALCL) in France, the French government have advocated the removal of all PIP implants from women. In contrast, the MHRA in the UK does not advocate the routine removal of implants as there is no evidence of increased risk of cancer in patients with PIP implants based on MHRA independent investigations.4 De Jong et al. stated that there is a very rare association of 1 in a million between ALCL and breast implants but not a causal link.5 Furthermore breast-associated ALCL occurred rarely in women with and without breast implants and no type of implant was attributed to ALCL.6 Epidemiological reviews have also concluded that there is not an increased risk of ALCL in patients with breast implants.7,8 An expert review group with representatives from Association of Breast Surgery, the British Association of Plastic and Reconstructive Aesthetic Surgeons, the British Association of Aesthetic Plastic Surgeons, the Federation of Surgical Speciality Associations and the Royal College of Surgeons have advised surgeons to remove PIP implants if requested by the patient or if there is evidence of implant
Figure 3
Representative histology from siliconoma.
PIP breast implants leak or rupture. Symptoms suggestive of implant rupture include change in breast shape, hardening, tenderness or lumpiness of the breast and or regional swelling of the lymph nodes.9 There are thought to be over 40,000 women in the UK whom have been implanted with PIP breast implants.10 The impending increase in the incidence of patients presenting with ruptured PIP implants is a problem that General Practitioners and Plastic Surgeons will encounter. The questions arising at this stage are ‘what is the risk of rupture and siliconoma formation in patients with PIP implants’? Also, does the relatively small risk of surgery to remove intact implants outweigh the risk of implant rupture and siliconoma formation requiring more extensive and higher risk surgery? We advocate that ruptured implants should be a differential diagnosis of supraclavicular fullness in a woman with PIP breast implants. We also recommend that all Surgeons continue to report problems that patients develop with PIP implants to the MHRA via their website reporting service. This will empower the MHRA to decide if all PIP implants should be removed.
Conclusion We report this case to highlight an atypical presentation of PIP implant rupture with extensive lymph node enlargement.
Conflict of interest/funding None.
Acknowledgements Ms Rajshree Jayarajan (Clinical Fellow in Plastic Surgery, Leicester Royal Infirmary) provided the photographic images of the operative specimens.
269 Dr Esme Pointen (Consultant Histopathologist, Leicester Royal Infirmary) provided the images of the histology slides of the operative specimens.
References 1. Wintsch W, Smahel J, Clodius L. Local and regional lymph node response to ruptured gel-filled mammary prostheses. Br J Plast Surg 1978;31:349e52. 2. Tests effectue ´s sur les prothe `ses mammaires en gel de silicone PIP 28.09.2010 AFSSAPs. http://www.afssaps.fr/Dossiersthematiques/Implants-mammaires-PIP-pre-remplis-de-gel-desilicone/Tests-effectues-sur-les-protheses-mammaires-en-gelde-silicone-PIP/(offset)/3. [Accessed 14.03.12]. 3. MHRA Medical Device Alert 31 March 2010: Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP) e all models and lot numbers (MDA/2010/025). http://www. mhra.gov.uk/home/groups/dts-bs/documents/ medicaldevicealert/con076500.pdf. [Accessed 14.03.12]. 4. MHRA Press release 23 December 2011: Poly Implant Prosthese (PIP) breast implants update. http://www.mhra.gov.uk/ NewsCentre/Pressreleases/CON137935. [Accessed 14.03.12]. 5. de Jong D, Vasmel WL, de Boer JP, et al. Anaplastic large-cell lymphoma in women with breast implants. J Am Med Assoc 2008;300:2030e5. 6. Jewell M, Spear SL, Largent J, et al. Anaplastic large T-cell lymphoma and breast implants: a review of the literature. Plast Reconstr Surg 2011;128:651e61. 7. Lipworth L, Tarone RE, McLaughlin JK. Breast implants and lymphoma risk: a review of the epidemiologic evidence through 2008. Plast Reconstr Surg 2009 Mar;123:790e3. 8. Deapen D. Breast implants and breast cancer: a review of incidence, detection, mortality, and survival. Plast Reconstr Surg 2007 Dec;120(7 Suppl. 1):70Se80S. 9. Poly Implant Prosthese PIP breast Implants. Joint surgical statement on clinical guidance for patients, GPs and surgeons. Royal College of Surgeons of England, http://www.rcseng.ac. uk/publications/docs/pip-statement/?searchtermZPIP; January 2012 [Accessed 14.03.12]. 10. MHRA Press release 21 April 2011: French regulator confirms non-toxicity of PIP breast implants. http://www.mhra.gov.uk/ NewsCentre/Pressreleases/CON114614. [Accessed 14.03.12].