The ruptured breast implant: legal pathways to compensation and defences against litigation.

#breastimplant #medicalnegligence #PIPimplants #strictliability

Summary

Unlike what the majority of patients believe, breast implants are not for life and will eventually require some form of surgical "maintenance".

Implant rupture is a common complication of breast augmentation surgery, therefore compensation claims for rupture will not be successful, unless it can be proven that there was either surgical negligence or a defective implant.

In the UK, there are three pathways in the pursuit of damages for a defective breast implant: a civil suit under contract law, a suit under tort law (delict in Scotland), and a suit under the strict liability regime. This post will expand on these and provide an algorithmic approach for solicitors dealing with relevant case (see end of post).

Introduction

Breast augmentation with breast implants is the most popular cosmetic procedure performed privately in the UK.[1] Breast implants are also widely used in the National Health Service (NHS) for breast reconstruction patients, usually after breast cancer surgery.[2] Cosmetic use of breast implants in the NHS is also possible in some Health Boards, but only in severe cases of breast asymmetry or underdevelopment; patient eligibility in these cases is assessed on a case-by-case basis, by a multidisciplinary panel comprising plastic surgeons, psychologists and specialised nurse practitioners. In Scotland, this forms the Exceptional Referral Pathway.[3]

Breast implants are made up of an outer layer (shell) and an inner layer (core). The surface of the implant may be smooth or textured. High quality, newer generation implants often have an extra layer of silicone interposed between core and shell, which reduces silicone migration from the core to the shell and helps keep the implant’s shape in the event of ruptures.[4] In the United Kingdom, the vast majority of implants are made entirely of silicone. In the United States, saline implants are often widely used; these have a silicone shell and a saline-filled core.[5]

There is scientific consensus that breast implants are safe. The landmark reviews investigating implant safety profiles were published in 1998 in the UK[6] and in 1999 in the US.[7] Both reviews showed that there was no evidence that silicone implants cause any major diseases, including breast cancer, autoimmune diseases and connective tissue disorders.[8] The reviewers pointed out that everyone is exposed to silicone constantly in daily life and also found that breast milk from women with silicone implants contain less silicone than breast milk, meaning that women with silicone implants could safely breast feed. Despite both reviews, consumers in the US favoured saline over silicone implants for years to come, despite the fact that even saline-filled implants have an outer shell made entirely of silicone. In recent years, a possible association between breast implants and a rare form of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma (ALCL) has been identified, but has not been conclusively proven, due to its extreme rarity.[9]

Implant rupture is a well-known complication following breast augmentation surgery. Ruptured implants cause silicone leak. Rupture rates statistics vary widely but are considered to be around 10.1-13.6% after 8-10 years. The variation in reported rupture rates most likely reflects the fact that a lot of ruptures are asymptomatic and that different implant manufactures often commission their own studies, which can cause conflicts of interest.[10]

Early generations of implants were made up of incohesive silicone gel, therefore ruptures usually caused significant distortions of the implants, with migration of the silicone gel outside the implant pocket; silicone could often migrate to the axillary lymph glands, causing palpable lumps called silicone granulomas. Newer generation implants have vastly improved the cohesion of the silicone gel and ruptured implants often retain their shape making it difficult to detect ruptures when they are asymptomatic.[11] Symptomatic silicone leak can cause disruption of the implant shape, hardening of the scar tissue surrounding the implant (capsular contracture) and form lumps (granulomas) in the breast or axillary glands that can sometimes be painful. Women with ruptured implants have occasionally reported general, non-specific symptoms of malaise and pain, but there is no scientific evidence to support this claim.[12],[13]

Idiopathic (ie indeterminable) causes and direct trauma to the breast can cause implant rupture. Iatrogenic (ie surgeon-related) oversights can also cause ruptures; usually this occurs when the implant is punctured by the suture needle during closure of the wound. [14]

A patient with a ruptured implant, regardless of the reason for the loss of implant integrity, will be presented with various management options by her surgeon. In asymptomatic cases with no anatomical distortion, implants can be left in situ, as they pose no health risk. However, it is a reasonable request by the patient to have the implants exchanged.[15] This would require a surgical procedure, which is usually performed under general anaesthetic. In cases of bilateral implants, often both implants need to be exchanged or concurrent uplifting (mastopexy) procedures for the sake of anatomical symmetry, even if only one is ruptured. This would obviously significantly increase any associated costs for the patient, as breast implants are expensive medical devices.

In 2012, in the wake of the PIP breast implants scandal[16], Sir Bruce Keogh published an independent review of the regulation of cosmetic interventions.[17] Amongst his many recommendations was the need for a national breast implants registry to allow better monitoring of patient outcomes and device safety. Keogh recommended that the registry should be set up within 12 months, but this, and most of his other recommendations, have yet to be implemented by the government.

Rights to compensation under UK law

Compensation under contract law

For a successful civil suit under contract law, the patient must have had her implants placed privately (i.e. not within the NHS). The patient can file a suit for damages against their surgeon and/or their private clinic under the Consumer Rights Act 2015, on the grounds that the implant was neither of satisfactory quality nor fit for purpose. This would apply both in the event of iatrogenic injury to the implant and if the implant belonged to a particular brand or batch that was known to be defective.[18] Implantation of the device in either of these occasions would directly breach s.9 (3), s.9 (3)(c), s.9 (4)(c), and s.10 of the Act.

Compensation under the law of tort/delict

Pursuing damages under the law of tort/ delict can also be applied if the patient has had her implants placed in the NHS. Furthermore, in my opinion, the scope of a delictual claim is wider than a claim under contract law because it is applicable not only to iatrogenic implant damage, but also to inappropriate consent process, as explained later.

The test established in Donoghue v Stevenson[19] must be met in order to establish liability here. It is incontrovertible that both the surgeon and clinic had a duty of care to the patient. Following this, breach of said duty of care can be proven if the surgeon inserted a damaged implant in the patient’s breast and/or the implant used belonged to a faulty batch, causing rupture of the implant; this would necessitate further surgery for removal of the implant and could potentially cause a variety of other harmful symptoms to the patient, as explained previously. The clinical negligence test in Hunter v Hanley[20] and Bolam v Friern Hospital Management Committee[21] also apply here[22] under certain provisions; firstly, that the surgeon failed to check the implant’s serial numbers against the pharmacovigilance database to ensure that no alerts had been issued for it (this obviously only applies if the implant belonged to a defective batch).[23] Otherwise, in the event that the surgeon damaged the implant during surgery, failure to notice the damage would constitute breach of normal practice, as a cosmetic surgeon acting with reasonable care, would have taken steps to detect and avoid such an injury. Once the above criteria have been met, factual and legal causation can be established: the surgeon was a causal factor [24] and the injury both falls within his duty and was reasonably foreseeable.[25]

The landmark ruling in Montgomery v Lanarkshire Health Board [26]with its retrospective power can be very helpful in establishing liability in the event that the patient had not been appropriately consented before the operation. During the consent process, the surgeon should have made it clear to the patient that implant rupture was a possible complication of surgery and provided the most recent statistics on rupture rates. If the patient consented to surgery without this knowledge, a civil suit under the law tort/ delict would be a good strategy in pursuing damages.

Compensation under strict liability laws (Consumer Protection Act 1987)

The Consumer Protection Act 1987 imposes liability on the producer of a defective product without the need to prove negligence. The Act defines a ‘product’ as ‘any goods’[27] and further defines goods as ‘any natural or artificial substance whether in solid, liquid or gaseous form of vapour and includes substances that are comprised in or mixed with other goods’.[28] Based on these definitions, breast implants are considered goods under the Act, therefore the patient can use it to sue the implant manufacturer for damages without the need to prove clinical negligence. Even though s.2 (3) of the Act imposes liability on the supplier of the product (in this case, the surgeon), this liability is lifted once the supplier provides the identity of the manufacturer within a reasonable time. It would therefore be reasonable to assume that the patient’s surgeon and clinic will identify the implant manufacturer and therefore the suit under the 1987 Act should be directed against the implant manufacturer only.

For a successful suit under the Consumer Protection Act 1987, the patient will need to prove that the product was defective and that this defect caused damage to her. [29] According to the Act, a product is defective if its safety ‘is not such as persons generally are entitled to expect’.[30] Therefore, in the opinion of this author, in order for the patient to prove that her breast implant was defective, she must show that (1) it was either manufactured by a producer who knowingly produced defective implants (e.g. PIP), or (2) it belonged to a defective batch of implants, especially if the MHRA had previously issued an alert against its use, or (3) the time from surgery to rupture was significantly reduced compared to published figures.

The Consumer Protection Act 1987 defines ‘damage’ as ‘death or personal injury or any loss of, or damage to property’,[31] while ‘personal injury’ is defined as ‘any disease and any other impairment of a person’s physical or mental condition’.[32] In the context of this case, the patient will have to undergo further surgery to exchange her implant, exposing herself to unnecessary medical risk. Recovery from her surgery will cause physical impairment and inability to engage in normal work and physical and social activities. [33]

The patient should be aware of the time limitations when pursuing a suit under strict liability law, namely that she must sue within 3 years from injury or from becoming aware of injury and that she cannot sue the manufacturer of a product that has been in the market for more than 10 years.

Special considerations (defences against litigation)

The patient must be aware of potential defences against her civil suit, regardless of which legal pathway she chooses.

It is important to identify potential factors that can break the chain of causation and reduce the defendant’s liability, such as intervening events from third parties (eg trauma to the breast) or contributory negligence (eg non-restrained car passenger involved in accident).[34]

In pursuing damages under the Consumer Protection Act 1987, there are a number of defensive strategies that can be used against the patient’s suit. The easiest of these would be for the manufacturer of the implant to prove that there was no defect at the time of supply,[35] i.e. that there was third party tampering (the surgeon damaged the implant during surgery). In older generation implants, the manufacturer could also refer to s.4 (1)(e) of the Act to defend against a suit by showing

‘that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect if it had existed in his products while they were under his control’.

Case law

A search on LexisNexis and Westlaw UK did not identify any cases that could establish legal precedent. In Foster v Biosil [36] the claimant Mrs Foster sued the company that manufactured her implants for damages under the Consumer Protection Act 1987. The claimant alleged that both her implants were defective, because the left implant ruptured prematurely and the right implant leaked silicone. The county court held that the burden of proof to show defect and causation was on the claimant, who on the balance of probabilities failed to establish a defect in either of the breast implants. The fact that the claimant’s expert witness incorrectly tested the implant was crucial in the court’s decision; this further highlights the importance that thorough implant testing is performed after surgery if possible.

In McCarthy v Davis [37] the effect of an intervening event in the chain of causation is shown. In this case, the claimant’s right breast implant was ruptured during a road traffic accident and she subsequently had to wait 11 months for the implant replacement. She also developed postoperative complications and had to stay in hospital for one week after her surgery. The claimant brought a successful suit for damages against the driver of the vehicle that caused the accident; she was awarded general damages of £6,500 (in 2000). In this case, it was obviouslt recognised that the patient’s surgeon and implant manufacturer could not be held liable for the actions of the third party during the accident and were therefore never sued.

Conclusion

It is incontrovertible that implant ruptures are well-documented complications of implant augmentation surgery; nevertheless, this does not exclude surgeons, clinics, and manufacturers from legal liability. In pursuing damages, one of the most important steps for the patient is to identify whether the breast implant was ruptured due to normal ‘wear and tear’, or if the rupture was the result of iatrogenic damage by the surgeon or due to an inherently faulty implant. In the former, a civil suit might not be successful, especially if the rupture occurred in a timeframe that falls within the national statistical average and that the risk of rupture was adequately explained during the consent process. However, if the damage to the implant was due to errors by the surgeon or the manufacturer, legal damages can be pursued in three ways: under contract law, under the law of tort/delict, or under strict liability law. This is summarised in the following algorithm. Finally, timeframes for the submission of compensations claims as well as potential defences against the claims are also highlighted.

References [1] See national statistics released by the British Association of Aesthetic Plastic Surgeons in January 2016 (baaps.org.uk/about-us/press-releases/2039-auto-generate-from-title) [2] See NHS Choices website (www.nhs.uk/Conditions/breast-implants/Pages/introduction.aspx) [3] See www.pathways.scot.nhs.uk/plasticsurgery.htm [4] S. Bondurant and others, Safety of Silicone Breast Implants (National Academies Press 2000) [5] US Food and Drug Administration, 'FDA update on the safety of silicone gel-filled breast implants' (2011) Silver Spring, Md: Center for Devices and Radiological Health [6] RD Sturrock and others, 'Silicone gel breast implants: the report of the independent review group' (1998) Cambridgeshire, UK: Jill Rodgers Associates [7] Bondurant and others, Safety of Silicone Breast Implants [8] It is of little surprise that prior to the FDA publication in 1999 numerous suits were filed in the US by women who claimed that having breast implants caused them major illnesses (usually connective tissue or autoimmune disorders). These claims were based on the tort of negligence, strict liability regimes, and breach of express and implied warranty. However, after the publication of the FDA report, most claims of this nature were no longer brought forward as they were not deemed to be successful. [9] Despite the very low reported numbers, the US Food and Drugs Administration (FDA) reported that the presence of ALCL in patients with breast implants might not be a coincidence. See also fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm [10] Food and Administration, 'FDA update on the safety of silicone gel-filled breast implants' [11] Ibid [12] Bruce Keogh, 'Poly implant prostheses (PIP) breast implants: final report of the expert group' (2012) National Health Service, UK [13] Food and Administration, 'FDA update on the safety of silicone gel-filled breast implants' [14] Ibid [15] Keogh, 'Poly implant prostheses (PIP) breast implants: final report of the expert group' [16] Breast implants manufactured by the French company PIP were found to contain industrial grade silicone. This caused a global healthcare scandal, affecting an estimated 300,000 women in 65 countries. See also nhs.uk/Conditions/PIP-implants/ [17] B Keogh, 'Review of the regulation of cosmetic interventions' (2013) London: Department of Health [18] If the patient has received implants manufactured by the French company PIP, who have recently been found guilty of fraudulently using non-medical grade silicone in their implants, it would be advisable to join the Group Litigation Order that has been formed in the UK. See also justice.gov.uk/courts/rcj-rolls-building/queens-bench/group-litigation-orders/the-pip-breast-implant-litigation [19] 1932 SC (HL) 31; [1932] AC 562 [20] 1955 S.C. 200; 1955 S.L.T. 213 [21] [1957] 1 W.L.R. 582; [1957] 2 All E.R. 118 [22] Because breast augmentation surgery is a common procedure with a well-established ‘usual and normal’ practice. [23] In the UK, the MHRA issues alerts which all doctors should be aware of. See www.gov.uk/drug-device-alerts [24] Satisfies the ‘but for’ test. [25] The clinic is vicariously liable for employing the surgeon. [26] [2015] UKSC 11; [2013] CSIH 3; 2013 S.C. 245 [27] S. 1(2) [28] S. 45(1) [29] See also Foster v Biosil (2000) 59 BMLR, analysed in para 5.1 [30] S. 3(1) [31] S. 5(1) [32] S. 45(1) [33] See also McCarthy v Davis 178 [2000] C.L.Y. 1647, analysed in para 5.2 [34] See also para 5.2 of this report [35] S.4 (1)(d) [36] (2000) 59 BMLR 178 [37] [2000] C.L.Y. 1647