Breast Implants, Cancer, and Safety Concerns: What You Need to Know

Breast Implant History and Restrictions

The safety of breast implants has been a long-standing and controversial topic, with conflicting opinions from scientists, surgeons, and patients. In 1992, the FDA placed restrictions on silicone breast implants in the USA, allowing their use only for reconstructive purposes following mastectomy, correcting congenital deformities, or replacing existing implants in patients aged 21 or over.

Silicone Implants for Reconstruction: An Ethical Dilemma

Another confusing element was that silicone implants were deemed low risk when used for reconstruction after breast cancer surgery. This raises ethical concerns, if there were any safety doubts, why were they still used for such a vulnerable group of patients? It seems morally questionable to offer a potentially unsafe option to women undergoing reconstructive surgery after battling cancer.

Europe and the FDA Reversal of Silicone Implant Restrictions

Despite these concerns, European countries continued to use silicone implants, with research at the time suggesting no significant link between silicone illness or breast implant-associated (BIA) illness. Based on this data, in November 2006, after 14-years, the FDA lifted the restrictions on silicone implants, approving their use for cosmetic surgery, once again.

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The Link Between Breast Implants and Cancer

The landscape changed dramatically on 24th July, 2019, when Allergan voluntarily recalled its Biocell saline-filled and silicone-filled textured breast implants and tissue expanders worldwide, following a request from the FDA. This action followed the discovery of a link between these implants and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare form of non-Hodgkin lymphoma.

For the first time, a direct and scientifically recognised connection between breast implants and cancer was established. Notably, this link was unrelated to the type of filling—whether saline or silicone—but rather to the textured surface of the implant shell. Although the first case of BIA-ALCL, diagnosed in 1997, involved saline-filled implants, the data indicates that the more textured the shell, the greater the risk. To date the highest number of BIA-ALCL cases have been associated with Allergan’s highly textured implants.

As of 31st December, 2021, the UK had 87 confirmed cases of BIA-ALCL, all but 2, whose implant history is unknown, were textured implants. The implant manufacturers with reported cases of BIA-ALCL are:

• Allergan - 27 cases
• Eurosilicone SAS - 1 case
• Mentor Medical Systems B.V. - 4 cases
• Nagor Limited - 4 cases
• Polytech Silimed Europe GmbH - 1 case

The Food and Drug Administration (FDA) has received 1264 medical device reports (MDRs) for BIA-ALCL worldwide, as of 30th June, 2023.

Accountability and Compensation for BIA-ALCL: Allergan's Role

On July 30, 2019, Allergan announced it would cover the costs of new implants for women with Biocell implants who wanted them replaced. This program ended 24th July, 2021.

Legal Action and Class Action Lawsuits

Women who have received Allergan Biocell implants and are concerned about BIA-ALCL have legal options. In the U.K., Leigh Day is pursuing legal action against Allergan, seeking compensation for the cost of removal, personal injury, distress, and financial loss.

This is the first lawsuit in the U.K. from women affected by BIA-ALCL, who claim they were inadequately informed about the risks. Join the Leigh Day, Allergan Textured Breast Implants Claim in the UK

In the USA several law firms have filed class-action lawsuits against Allergan to secure compensation for women with BIA-ALCL symptoms or diagnosis.

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Should You Remove Your Breast Implants?

In the latest statement from the Center for Devices and Radiological Health (CDRH) released by the FDA on the 28th February, 2024, the advice is 'Given that the occurrence of BIA-ALCL is uncommon, prophylactic removal of textured implants is not recommended in asymptomatic patients.'

In the U.K, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued similar guidance. The MHRA does not advise the routine removal of textured implants, including Allergan Biocell, for women without symptoms.

Ultimately, the decision to remove or replace your implants should be based on your risk factors and how you feel. Your mental health is really important and if you're experiencing anxiety about the potential risks associated with your implants you might want to consider implant removal or replacement. If you have textured implants, it's essential to stay informed and consult your surgeon for advice about any breast changes or symptoms of concern, such as persistent swelling, lumps, or pain around the implant area.

Implant Maintenance: Breast Implants and Bras

Following breast augmentation or reconstruction, maintaining proper support is crucial to preserving breast shape. During the first three months post-surgery, it's essential to wear a non-underwired bra to allow the implants to settle properly into their pockets. After this period, wearing a supportive bra may help to prevent implant displacement and reduce sagging, over time.

If you opted for submuscular placement (under the muscle), your muscle will provide some degree of natural support for your implants, and some women can go braless comfortably. Always consult your surgeon for guidance after breast augmentation, on when you can start wearing underwired bras and whether to wear a bra long-term.

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Are Breast Implants Lifelong Devices?

Previously, it was recommended that breast implants be replaced every 10 years. This was partly due to the expiration of manufacturer warranties, which increased the risk of lawsuits for implant failure over time. Today, most manufacturers offer lifetime warranties, and the general consensus is that silicone gel-filled implants are durable and do not require replacement unless a rupture or other complications arise.

For more information, consult with your surgeon about your breast implants and any ongoing concerns.

Final Thoughts

Allergan and other breast implant manufacturers should be held accountable for the risks their products pose, and patients impacted deserve full compensation. Always consult your surgeon to check the type of implants you have and stay informed about monitoring for any potential signs of a defect or symptoms that are unusual after breast augmentation or reconstruction with implants.

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Resources

Below is a curated list of resources and scientific studies that provide evidence and support for the content discussed in this article. These references offer valuable insights and further reading on key topics, helping to validate the information and provide a deeper understanding of the subject matter.

• Breast Implants, Breast Implant Illness (BII) and Cancer Update. July 2023. Available from: Cosmetic Surgery Advancements
• FDA Update on the Safety of Silicone Gel-Filled Breast Implants . June 2011. Available from: Center for Devices and Radiological Health U.S. Food and Drug Administration
• FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. Available from: U.S Food and Drug Administration (FDA)
• DePaola NEK, Coggins H. Breast Implant-Associated Anaplastic Large Cell Lymphoma: What We Know. J Adv Pract Oncol. 2019 Jan-Feb;10(1):54-61. Epub 2019 Jan 1. PMID: 31308988; PMCID: PMC6605706. Available from: NLM database
• Guidance Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Available from: Medicines & Healthcare products Regulatory Agency (MHRA)
• Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Available from: U.S Food and Drug Administration (FDA)
• Textured breast implants claim. Available from: Leigh Day
• CDRH Statement: CDRH’s Continued Commitment to Breast Implant Safety. Available from: FDA