Is Breast Implants Safe Now?

The most common question I have heard from many patients regarding breast implants in recent times is:

Are breast implants safe now?

This question has been raised due to recent news coverage that published the connection between breast implants and rare adverse outcomes including autoimmune disorders and cancer. So, I thought I will lift the lid over the safety of breast augmentation out of the controversial story that has stormed the world for almost a decade and this issue is still not resolved.

Millions of females have breast implants and around 400,000 females in the U.S. opt for breast implants every year, as per the American Society of Plastic Surgeons. Among them, 300,000 go for cosmetic surgeries while 100,000 go for reconstructive surgeries. Saline or silicone-type breast implants are used in all these surgeries. In spite of their extensive popularity, the safety of these implants has been at the center of rising public turmoil since the 1980s due to its connection with an increased risk of systemic diseases. However, this controversy was subdued by a 1999 research study published by an Institute of Medicine. This study concluded that there was no substantial evidence to support a direct association between the use of breast implants and systemic diseases.

In the US, FDA Breast Implant Post Approval Studies: Long-term Outcomes in 99,993 Patients published in the Annals of Surgery [1], Anderson M.D. The research team observed the outcomes of prospectively collected data on nearly 100,000 females who underwent saline or silicone implant-based breast reconstruction (13%) and cosmetic breast enhancement treatment (87%) between 2007-2009. 83 percent of patients received silicone implants as they are comparatively lighter and more natural. The outcomes of every patient were assessed during 3-4 post-operative visits and yearly follow-ups.

The rate of systemic harm was compared between patients with silicone implants and the general population. Patients with saline implants were excluded from reporting. Finally, patients with silicone breast implant repertoire systemic diseases such as Sjogren’s syndrome, rheumatoid arthritis, scleroderma, dermatomyositis, melanoma, multiple sclerosis, myositis, and neurological disorders twice the general population. Lesser than 3% had implant rupture. Only one case of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) was also reported by the patient associated with textured implants. Its incidence varies from 1 in 3,800 to 1 in 30,000 females with textured implants. To date, around 457 females have been diagnosed with BIA-ALCL malignancy, which prompted the FDA to issue a warning letter to physicians on February 6, 2019, to look out for this rare disease.

BIA-ALCL forms around the implant region. So, it can be treated if diagnosed early. The FDA also recommends that this condition should be taken into consideration if the patient comes with new-onset pain around the implant, breast swelling, erythema, or fluid accumulation around the implant.