Adverse incident reporting to the Medical Devices Agency — a review of reports involving Trilucent breast implants

British Journal of Plastic Surgery (2000), 53, 313 316 9 2000 The British Association of Plastic Surgeons doi: 10.1054/bjps.2000.3353

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SPECIAL TOPIC Adverse incident reporting to the Medical Devices Agency - a review of reports involving Trilucent breast implants A. Austin Medical Devices Agency, Hannibal House, Elephant & Castle, London SE1 6TQ, UK The Medical Devices Agency (MDA), an executive agency of the Department of Health, is responsible for the regulation of medical devices within the UK. One of MDA's roles is to investigate adverse incidents involving medical devices. Reports of problems are received from various sources including healthcare professionals and manufacturers, the latter having a legal responsibility to report serious events under the Medical Devices Regulations.~ However, since the system for reporting adverse incidents to MDA by clinicians and other healthcare professionals is voluntary, under-reporting is a problem. During the investigation of an adverse incident report, MDA will contact the manufacturer, arrange for the device involved to be analysed and look at trending data. MDA is not involved in clinical practice issues; their investigations concentrate on the performance of the device. An investigation, in some instances, leads to the publication of an advisory notice or other corrective action. However, it may conclude that the problem was not specifically device related or that the device performed as expected under its conditions of use. Trilucent breast implants were first marketed in the UK in 1995 and since then around 5000 UK women have received these implants. In March 1999, MDA issued an Advice Notice 2 informing UK clinicians of the voluntary withdrawal of Trilucent breast implants from the UK market. The manufacturer withdrew the product as a precautionary measure to allow further investigation of the long-term effects of the oil filler. This article describes incident reporting patterns for Trilucent breast implants; it does not report the conclusions of MDA's investigations of those reports. The prevalence of each failure type is not discussed; it should, however, be noted that many of them are common to all breast implants.

In the period between January 1996 and November 1998, MDA logged 58 adverse incident reports concerning Trilucent breast implants. The majority (93%) of these were reported directly by the manufacturer. Reported problems have included implant rupture (on occasion associated with local swelling), loss of implant volume, capsular contracture and some reports of implant removal for non-device related reasons. Reports from other sources included two from hospitals (one of rupture and the other of deflation) and one directly from a woman whose implants had leaked. In November 1998 the President of the British Association of Plastic Surgeons reminded his members that concerns regarding Trilucent breast implants should be reported to MDA. In the subsequent period (December 1998 to March 1999) a total of 17 reports were received. The numbers of reports made by hospitals increased from 3% to 52% of reports logged by MDA. Reports included implant rupture (in some cases associated with local swelling); the presence of a milky fluid around the implant and capsular contracture. One report directly from an implanted woman

35 DReports received from Members of the Public

Reporting patterns of incidents involving Trilucent breast implants Figure 1 shows the numbers of reports logged by MDA for the period January 1996 to the end of December 1999. The number of reports directly from hospitals and clinicians has increased. This may be due to increased awareness of MDA's role in monitoring adverse incident and the publicity surrounding the voluntary withdrawal of Trilucent breast implants.

Pre 1997

Jan-June 1997

July-Dec 1997

Jan-June 1998

July-Dec 1998

Jan-June 1999

Juiy-Dec 1999

Time Periods

Figure 1--Numberof reports receivedinvolvingTrilucentbreast implants. 313

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British Journal of Plastic Surgery

Table 1 Types of problems reported to MDA involving

Trilucent breast implants Number of reports

Reported problem

53

Rupture/leakage (30 of these involved local swelling) see Table2 for more details Capsular contracture Leakage of filler/lossof implant volume Aesthetic removal,e.g. implants not the desired size Rippling Removals due to health concerns Miscellaneous

13 14 4 3 11 22

was received during the same period; her implants had leaked. Following the release of MDA's Advice Notice 2 in March 1999, MDA received a further 45 adverse incident reports. Of these, 47% were from hospitals and 15% were directly from women with implants. The women were concerned about a range of issues including implant shape change, capsular contracture, rupture and the possibility of adverse health effects. In the period from the initial release of the device to December 1999, MDA received a total of 120 adverse incident reports involving Trilucent breast implants (Table 1). Many of these reports are still under investigation. As is shown in Tables 1 and 2, some reports of rupture are associated with a swelling of the breast. In some of these cases the women presented with asymmetry which they thought was caused by a deflation of the unswollen breast. In a few cases, the surgeon diagnosed rupture of the implant in the unswollen breast. In some cases imaging of the swollen breast revealed fluid around the implant. The manufacturer believes that this swelling may be due to a local inflammatory reaction and that it resolves after the implant has been removed. MDA and the manufacturer are particularly keen to get information on these cases prior to the implant being removed. Analysis of the implant filler (correctly stored to prevent ex-vivo degradation) may give an insight into the degradation of the filler and help investigate any relationship with the swelling seen.

Discussion

Since the voluntary withdrawal of Trilucent breast implants by the manufacturer, Collagen Aesthetics Incorporated has worked with MDA and the NHS Executive to agree a programme of support for patients and doctors. All patients concerned about their implants are encouraged to obtain a consultation by a healthcare professional. If there is concern that the implant has ruptured, patients should proceed to an MRI scan. Patients with evidence of ruptured implants are advised to have revision mammaplasty. This programme appears to have worked satisfactorily

for the majority of women and the company will continue to follow these recommendations. Update on use of M R I An update on the use of MRI in diagnosis of implant rupture has also been released. In summary, in the MDA Advice Notice clinicians were advised that 'MRI should not be carried out because this may cause damage from heating up the transponder'. After further consultation and confirmation that MRI is the only effective non-surgical means of diagnosing rupture, this advice has been updated to 'If an MRI scan has been recommended, you should advise the referring clinician and M R I radiographer that the person has a Trilucent breast implant so that the scan can be carried out with due care'. If MRI is carried out, this should be done with caution and awareness of the possibility of the R F induced heating effect. More information can be found on MDA's website. 3 Adverse incident system for medical devices MDA is keen to hear about problems with any medical device. Most clinicians are familiar with the yellow card system for reporting suspected adverse effects from drugs to the Committee on Safety of Medicines at the M C A ? However, fewer are aware that a similar system is in place for reporting incidents involving medical devices. MDA's report forms can be obtained by contacting the Adverse Incident Centre, MDA, Hannibal House, Elephant and Castle, London SE1 6TQ or from MDA's website, http://wwwmedicaldevices.gov.uk/mda-aic.htm. In addition most NHS Trusts have a liaison officer who has a role in coordinating the reporting of adverse incidents to MDA. A few of the reports logged by MDA from clinicians involve implants which were removed some time ago. There are several possible reasons why reports are not made at the time an incident takes place. In some cases clinicians may not be aware of MD,~s role in adverse incident inveStigation or their responsibility to report incidents to MDA. Alternatively they may believe that the incidents are an isolated problem or an example of an anticipated complication, such as breast implant rupture. However, MDA is always keen to hear about any incidents, since although they may not require individual investigation, such reports help to build up information on trends. Guidance document MDA has recently produced guidance to help manufacturers and healthcare professionals to decide whether an incident involving breast implants is reportable to MDA. The guidance was prepared in consultation with the British Association of Plastic Surgeons, the British Association of Aesthetic Plastic Surgeons and relevant manufacturers. This document is being circulated to all members of the professional bodies and to breast implants manufacturers; copies can be obtained from the European Regulatory Affairs section of MDA. 5

Trilucent breast implants

315

Table 2 Information relating to the 53 reports involving rupture of Trilucent breast implants Length implanted (months)

Rupture diagnosed by

Increased breast size?

Surgeon's comments/other information

Not given Not given 16 15 Not given 12 15 23 24 Not given 23 21 29 31 20 20 29 31 26 34 34 5 24 31 26 24 24 21 28 16 12 Not given 36 34 24 20 43 35 35 42 19 36 30 40 35 39 42 38 Not given 16 Not given 31 26

Not given Not given Not given Not given Not given MRI Ultrasound Ultrasound Not given Not given Not given Not given Not given Not given Not given Ultrasound Not given MRI Not given Not given MRI Not given MRI Not given Not given MRI Ultrasound MRI Not given Not given MRI & Ultrasound Not given Ultrasound MRI & Ultrasound Ultrasound Ultrasound Ultrasound Not given MRI & Ultrasound MRI Not given MRI Not given MRI MRI MRI Not given MRI MRI MRI Not given Not given Not given

No No No No Yes Yes Yes Yes No No Yes Yes No Yes No Yes Yes Yes Yes No Yes Yes No No No Yes No Yes No No Yes No No Yes Yes Yes Yes No Yes Yes Yes No Yes Yes Yes Yes No No Yes Yes No No Yes

Implant discarded

Conclusions

MDA is continuing to investigate reported problems with Trilucent breast implants and will issue further advice as necessary. Adverse incident reports from clinicians to MDA are an important source of information and enable the investigation not only of individual incidents but also

Implant discarded

Implant found to be intact on analysis Contents of prosthesis cloudy Implant discarded

Patch noted to be detached Noticed valve patch becoming detached 500 ml milky-coloured fluid within capsule

Fluid accumulation within capsule 400 ml clear yellow fluid drained implant intact Large quantity thick yellow fluid, rancid smelling Implant very adherent to underlying tissue MRI identified fluid within capsule

Implants discarded White fluid around implant Emulsion-like liquid within capsule Implant covered in thick waxy substance

Creamy homogenised oil noted within capsule Fluid accumulation within capsule Implant discarded Implant discarded Implant discarded Oily peroprosthetic fluid within capsule

Yellow turbid fluid within capsule Yellow custard-like fluid found within breast cavity -300 ml white, creamy, fatty fluid present Periprosthetic fluid surrounding implant Periprosthetic fluid surrounding implant Periprosthetic fluid surrounding implant

of trends, thus helping to ensure that medical devices used are safe and suitable for their intended purpose.

References 1.

The Medical Devices Regulations, Consumer Protection 1994 No 3017.

316 2. MDA AN 1999(01), Trilucent breast implants: Voluntary recall; issued by MDA, Hannibal House, Elephant and Castle, London SE1 6TQ. March 1999. 3. http://www.medical-devices.gov.uk/tbi-mri.htm 4. Committee on Safety of Medicines, Medicines Control Agency, CSM Freepost, London SW8 5BR. 5. European Regulatory Affairs, MDA, llth Floor, Hannibal House, Elephant and Castle, London SE1 6TQ, tel 020 7 972 8223, fax 020 7 972 8112.

British Journal of Plastic Surgery The Author Alison Austin Medical Devices Agency, Hannibal House, Elephant & Castle, London SE1 6TQ, UK