Is Breast Implants Safe Now?

Overview

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.

In 1992, the FDA restricted the use of silicone gel breast implants to females having reconstruction after their surgical procedure for breast cancer. Females had to select saline breast implants for their breast augmentation.

Later in the year 2006, when no research studies or surveys established a direct connection between silicone implants and immunological diseases, the FDA looked into this issue, and the FDA approved the sale of several silicone implants.

Mark W. Clemens, M.D., associate professor, Plastic Surgery and Senior Investigator, said

This study did not report a direct link or causative effect between implants and these diseases. It is important to understand the limitation of the study was that some diseases were reported by patients and not necessarily diagnosed by a physician.

In October 2019, the FDA released the proposed language for labeling the new breast implants, including a black box warning upon the implants. A patient decision checklist should also be attached as well to ensure that the females opting for implants are well-informed about the risks. Binita Ashar, MD, director of the FDA’s Office of Surgical and Infection Control Devices, said

This admonition is the most noticeable thing we can do to focus on the issue. We need patients to realize that we accept their reports of manifestations. Also, we’re attempting to find out more so we can all the more likely anticipate which patients may encounter issues and who may have to stay away from breast implants.

The surgeons must educate their patients completely by discussing these systemic harms. Females must be well aware of these potential risks before weighing the pros and cons of saline VS silicone implants.

How should you help your patients to reduce the risk of systemic harm with breast implants?

After discussing the risks of breast implants, you should consider the following:

1. Select a saline-based breast implant instead of a silicone implant
2. Even if the patient prefers silicone implants due to their better natural look, choose a smooth surface over the textured one.
3. It is better to reconsider implant augmentation if the patient has a family history of connective tissue or autoimmune disorders, despite getting negative results by performing formal tests.
4. Patients should continue to have yearly breast MRI tests along with mammography to assess any new symptoms in the implanted breast. By educating the patients, they can easily identify the symptoms well in advance and undergo timely treatment.
5. Remember that breast implants won’t prevent the breasts from sagging. The patient should go for a breast lift along with breast augmentation.
6. Some females can successfully breastfeed while others cannot.
7. Since there might be a chance of implant rupture, weight gain, or weight loss, there is a chance of removing the breast implant. Hence, they are not guaranteed to last a lifetime. However, in modern semi-solid silicone implants, leaks can be easily treated and replaced in an outpatient setting.
8. For augmentation, females who are 18 and more can have saline implants while females who are 22 and more can only opt for silicone implants.
9. Saline implants don’t have platinum, unlike silicone implants. Though people think that platinum can be injurious, the FDA says that there is no study that reports that platinum poses any risk in silicone implants.
10. The size of saline implants can be increased or decreased non-surgically even after undergoing augmentation. However, it’s not possible in the case of silicone implants since the silicone gel size is profiled and standardized.

Final Takeaway

The FDA has considered both silicone and saline breast implants safe and effective. Research on their safety and efficacy is ongoing. However, any surgery as well as implantable devices have potential side effects. As cosmetic surgeons, it is our responsibility to regularly monitor the safety of breast augmentation.

All physicians and patients should be well aware of all the possible complications associated with breast implants. Be armed with the right information so that you can take the right possible decision on reconstruction and augmentation. Similarly, females with breast implants should monitor themselves and report unusual symptoms if any.

Remember that breast implants can be a positive thing in the right patient with the proper care team. Yet, they are not free of risk.

References

1. Coroneos CJ, Selber JC, Offodile AC 2nd, Butler CE, Clemens MW. US FDA Breast Implant Post Approval Studies: Long-term Outcomes in 99,993 Patients. Ann Surg. 2019 Jan;269(1):30-36. doi: 10.1097/SLA.0000000000002990. PMID: 30222598.