Breast implant manufacturer provides warranty against the development of a rare type of cancer

Posted: 31/01/2018

Allergan, one of the biggest manufacturers of breast implants, has become the first organisation of its kind to provide warranty cover for its products in cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). According to an Allergan statement, the company’s Natrelle ConfidencePlus warranty now includes ‘additional rare event coverage for patients with gel or saline filled implants diagnosed with BIA-ALCL on or after 1 January 2018’.

Development of BIA-ALCL is now recognised to occur, albeit at a very low frequency, in patients who have breast implants and, in particular, textured implants. Typical presentation of ALCL in this circumstance is development of a persisting seroma around the implant. More rarely patients will develop a lump with or without enlargement of axillary lymph nodes. As of November 2017, the Medicines and Healthcare products Regulatory Agency (MHRA) has received 41 reports of BIA-ALCL in the UK. Of those reported, there have been three deaths, but only one linked to ALCL.

If caught early, BIA-ALCL can usually be cured with surgery which removes the implants and surrounding scar tissue. However, in the US, health insurers do not cover cosmetic implants or related complications, so some patients have delayed seeing a doctor about suspected symptoms. In response to this problem, the American Society of Plastic Surgeons (ASPS) has urged manufacturers to provide an appropriate warranty.

Allergan’s recent decision has been considered by the ASPS as an ‘important recognition of this rare disease’ and a major step in ensuring patient safety. The warranty includes financial assistance of up to $7,500 in out of pocket surgical costs for the removal of the implants and the surrounding tissue. Allergan will also provide smooth implants at no charge to patients who opt for replacement.

Elise Bevan, a solicitor in Penningtons Manches’ clinical negligence team who specialises in legal claims involving BIA-ALCL, said: “On the face of it, this is certainly a step in the right direction and it should urge women both in the US and the UK to seek early advice if any symptoms develop. I hope that Allergan’s action will encourage all implant manufacturers to follow suit. The earlier BIA-ALCL is diagnosed, the better the outcome is likely to be. Symptoms tend to include the development of a swelling, build-up of fluid or a breast lump around the implant more than six months after having the procedure. If the surgeon or clinic which carried out the original implant operation is no longer available, then you should see your GP for referral to another surgeon. Having the warranty cover for any investigations and treatment should be reassuring to women.

“It is important that anyone undergoing breast implant surgery discusses the risks and benefits with their surgeon. Any procedure that may lead to the development of lymphoma and even death should be something that patients are fully aware of prior to undergoing breast implant surgery.”

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