Key words
benign mammary gland tumor - BRCA (breast cancer antigen) - breast - mammary gland
tumor - mammary malformation
Schlüsselwörter
benigne Mammatumoren - BRCA - Fehlbildungen der Mamma - Mamma - Mammakarzinom
Introduction
Back in May 2000, the US Food and Drug Administration (FDA) had already inspected
the production facilities of the implant manufacturer, Poly Implant Prothèse (PIP),
based in the south of France. Irregularities found resulted in PIP losing its US marketing
permit. Following the first public reports of defects in PIP breast implants in 2006
[1] and 2007 [2], the French medical products inspecting authority (Afssaps) ordered the suspension
of the sale and use of the PIP breast implants as of 29 March 2010. The decision was
based on the number of complaints and clearly increased rupture and leakage rate of
the products, ranging between 10 and 11 % [3]. The defects were due to the use of unapproved silicone material which did not comply
with manufacturing specifications. Equally affected were the M-Implants manufactured
by the Dutch company Rofil, as well as TiBREEZE breast implants made by
the company formerly known as GfE Medizintechnik GmbH. An increased mutagenicity of
the implant material had not been detected until then; however, figures as at 28 December
2011 show that a total of twenty patients with PIP implants had been diagnosed with
tumours. Since awareness of these issues in professional circles and the media was
initially low in German-speaking countries, the occurrence of these incidences caught
the publicʼs attention.
Since PIP implants had been used in German-speaking countries in reconstructive and
aesthetic surgery; one should be aware of incidents involving the company and the
medical and legal consequences for hospitals and practices.
Official Recommendations and Conclusions
Official Recommendations and Conclusions
From the moment the PIP implants were suspended up to the end of last year, the recommendations
of the Afssaps (also adopted by the German Federal Institute for Drugs and Medical
Devices, BfArM) advised PIP implant patients to undergo sonographic (or mammographic
if necessary) check-ups of the implants and axillary lymph nodes every six months.
In the event of a suspected implant rupture (even on one side only), both implants
should be removed as soon as possible.
Current physico-chemical analyses confirm clinical observations of unacceptably high
rupture rates of the implant envelope, as well as the use of unapproved industrial
silicone, which can cause local inflammation and axillary lymphangitis. Reports in
literature [4] include the occurrence of cutaneous manifestations in the form of siliconoma.
Previously, cytotoxicity or mutagenicity of the silicone filling had not been indicated
[5]; however, figures from the French Department of Health as at 28 December 2011 show
that tumors have been diagnosed in twenty PIP breast implant patients [6]. Sixteen cases indicated intramammary tumors (fifteen adenocarcinomas and one anaplastic
lymphoma) and four cases indicated tumors in areas other than the breast. However,
current investigations have not established a causal link between the breast implants
and the tumors. The incidence rate of tumors in PIP patients remains below that of
the total population.
Due to the number of reports of diffused seepage of the implant gel filling even without
clinical or radiological suspicion of rupture (gel bleeding), Afssaps changed its
recommendations on 23 December 2011, recommending the explantation of the implants
[7]. The BfArM adopted this recommendation on 6 January 2012, extending it to implants
made by the now insolvent Dutch company Rofil Medical Nederland B. V., which marketed similarly designed implants under its own name, i.e. the M-Implants models IMGHC-TX, IMGHC-MX and IMGHC-LS. An equivalent warning had been issued by the Dutch inspections authority, Inspectie
voor de Gezondheidszorg (IGZ), on 19 April 2010 [8]. Other products to be equally impacted include titanium-coated implants manufactured
with PIP components and marketed by the company formerly known as GfE Medizintechnik
GmbH from September 2003 to August 2004 under the brand name
TiBREEZE. There are no accurate figures for the number of PIP and Rofil products implanted;
estimates range from about 30 000 in France to 500 000 worldwide. In Germany, BfArM
has requested the federal state health authorities to provide figures on PIP/Rofil
implants, but to date none have been made available (as at 2 February 2012). The successor
of GfE Medizintechnik GmbH, pfm medical titanium GmbH, has indicated that 728 TiBREEZE implants have been put on the market.
BfArM recommends “that the implants in question be explanted as a precautionary measure”.
Treating physicians are requested to contact affected patients and communicate the
recommended procedure. “The urgency of each individual explantation depends on how
long the patient has had the implant. This should be discussed between the doctor
and each individual patient before the operation” [9]. Similarly, emphasis is placed on reporting incidents of damage as these are required
for more extensive risk minimising measures.
French experts further recommend a preoperative imaging of the breasts (MRI or sonography)
and a sonographic examination of the axillary lymph nodes. Where explantation is performed,
it is recommended that the implant capsule be removed as extensively as possible at
the discretion of the surgeon and a systematic histological examination conducted;
any periprosthetic fluid should also undergo cytological examination. Special after-care
following explantation is not required.
The BfArM internet site provides an unofficial translation of the expert advice of
the French National Cancer Institute, INCa, based on the Afssaps recommendations [10].
The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) made
its position on the topic known at European Community level with a statement issued
on 1 February 2012. On the basis of this opinion, the European Commission has requested
further extensive studies. The lessons from this situation are also to be included
in future revisions of the European Medical Devices Directive [11].
Clinical Case Study
We realised the hitherto lack of awareness of the connection between PIP and Rofil,
when a 27-year-old patient presented herself to our department in July 2010. She had
undergone aesthetic surgery in another clinic 3 years ago for breast augmentation
with 350 ml Rofil bilateral implants. The patient now indicated acute infection signs
of the right breast with fever and local swelling, as well as axillary lymphadenitis
and elevated inflammatory markers. A suspected ruptured implant and periprosthetic
infection was confirmed by MR imaging. Surgery was immediately performed. Thin liquid
pus was removed ([Fig. 1]) from the area of the implant, but a causative pathogen could not be established.
A tear was visible on the side of the implant facing the thorax ([Fig. 2]) as well as a diffused gel seepage (bleeding). A histological analysis indicated
a florid purulent, partly abscessed lymphadenitis with silicone traces in the
excised lymph nodes ([Fig. 3]).
Fig. 1 Intraoperative findings after opening of the implant pocket.
Fig. 2 Defective implant indicating gel bleeding and visible tear.
Fig. 3 Macroscopic view of excised, inflamed lymph nodes.
After further unobtrusive therapy and 6 months free of infection, the remaining left
implant could be removed and a bilateral re-augmentation performed. The clinically
asymptomatic remaining implant also indicated silicone exudation and a perforation
of the envelope.
Discussion
The aim of this publication is to provide our professional colleagues with an overview
of the so-called “PIP Scandal” concerning the company Poly Implant Prothèse through
the description of a typical case. The roles of the companies Rofil and GfE should
also be known in this context, as this has consequences for decisions on therapy,
as well as legal significance. With low-grade implants, the issue is one of product
liability and not of negligence on the part of the surgeon. Since the physicians were
not aware of the defectiveness of the implant and trusted the product on the basis
of the CE mark of quality, it is highly unlikely that compensation claims can apply
to the treating physicians. However, the damage to the reputation of the practices
or institutes involved is considerable. The certification body, TÜV Rheinland, has
also been the subject of public criticism for insufficient quality control; however,
it claims to have been deliberately deceived by the
manufacturer and has lodged a complaint against PIP stating that during its (announced)
on-site inspections, only approved products and documents had been presented.
It is not clear to what extent Afssaps was informed by the FDA of the deficiencies
already detected in the year 2000.
A further medico-legal issue in this matter is that in the case of a purely aesthetic
breast augmentation, treatment due to complications is considered a medically required
revision surgery following previous measures which were not medically indicated. German
state health insurance funds agree to cover such costs; however, according to the
revised Section 52, Para. 2 of the German Social Security Code, SGB V (limitation
of benefit based on personal responsibility) dated 1 April 2007, the patient is expected
to contribute “an appropriate amount” [12], resulting in potentially considerable follow-up costs for the patient. Some health
insurance companies have, however, declared that they will be applying their own discretion
to each individual case, in particular since the issue involves third party liability.
Similarly to the regulations governing French state health funds, private health insurers
will cover at least the full costs of diagnosis
and explantation in the case of aesthetic implants.
The PIP scandal once again poses the question of how to justify the clearly lower
requirements in approval procedures for medical devices compared with those applied
to pharmaceuticals. A mandatory central register could contribute to identifying and
remedying quality deficiencies more quickly after the products are put on the market.
Based on the dynamics of the events in the past months and the on-going investigations,
persons concerned are urged to follow developments with reference to the medical and
legal consequences for clinical practice.
