- The vast majority of women with breast implants have no adverse reactions, but growing evidence suggests a small number of patients may have biological responses to the implant materials.
- Symptoms like fatigue, brain fog, rash, memory loss, and joint pain have been reported by enough women with breast implants that the U.S. Food and Drug Administration (FDA) held a two-day meeting with patients, physicians, and implant manufacturers to explore the safety of silicone breast implants.
- Researchers are investigating these symptoms to understand their origin as what causes them is poorly understood at this time.
- Currently, conflicting research outcomes fail to offer definitive evidence that breast implants are associated with autoimmune or connective tissue disease. This does not mean, however, that there is not an association for some women who may be predisposed.
Due to growing concerns and claims from women who believe their breast implants made them sick, the FDA addressed the public on March 25-25, 2019, in a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss a range of topics concerning the safety of implantable medical devices, including the benefits and risks of breast implants used for cosmetic and breast reconstruction.
This came off the heels of public pressures to better understand why, by 2018, two Facebook pages, Breast Implant Illness and Healing and Breast Implant Victim Advocacy, had more than 50,000 women with breast implants report a range of symptoms that looked like those associated with autoimmune disease.
With no clear evidence to support what they were facing, many women who’ve suffered symptoms say it took them years of searching for answers before ultimately finding that it was their breast implants that were causing them harm.
What is breast implant illness?
Until recently, breast implant illness (BII) was an unofficial term being used by women to describe a broad set of symptoms caused by their implants. The chief among them: fatigue, memory loss, rash, brain fog, weakness, and joint pain.
The FDA has now listed BII to their list of potential breast implant risks, last updating their site on March 22, 2019.
There they say: “Symptoms such as fatigue, memory loss, rash, ‘brain fog,’ and joint pain have been reported by some patients with breast implants. Some patients may use the term ‘“breast implant illness’” (BII) to describe these symptoms. Researchers are investigating these symptoms to better understand their origins. These symptoms and what causes them are poorly understood.”
What was discussed at the FDA meeting on breast implants
The administration used the two-day forum to gather information from the public, scientists, plastic surgeons, and breast implant manufacturers so they could better understand the science, where the gaps in knowledge are, and what approaches should be considered to help them improve the safety of breast implants.
Some topics discussed included:
- Several health problems that patients have been calling breast implant illness
- Implants' link to a rare cancer of the immune system, called anaplastic large cell lymphoma
- The use of registries for maintaining breast implant surveillance
- Possibly banning breast implants with textured surfaces
Many plastic surgeons in the meeting reported patient satisfaction with breast implants but agree patients should have up-to-date information on breast implants in order to make a choice when considering them.
Patients at the meeting, who say they’ve suffered BII, advocated for:
- Mandatory testing for health risks associated with breast implants
- Improved communication and informed consent about the risks and benefits of breast implants (e.g., the use of warning labels and waivers prior to surgery).
FDA meeting resources (webcast and slideshow)
Day 1: http://fda.yorkcast.com/webcast/Play/a6baa43b37004ecab288779ac3a263bd1d
Day 2: http://fda.yorkcast.com/webcast/Play/8f0ba1b148174747b4dbd0ec916167f11d
FDA executive summary of meeting
What’s thought to cause breast implant illness?
Conflicting research outcomes fail to provide conclusive evidence that silicone breast implants are connected to the development of a specific autoimmune or connective tissue disease.
However, FDA Commissioner Scott Gottlieb and Director of the Center for Devices and Radiological Health Jeff Shuren, released a statement on March 15 about potential adverse reactions to materials used in implantable devices, including breast implants.
“The vast majority of patients implanted with medical devices have no adverse reactions. The device works and performs as expected,” read the statement, but “a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices.”
Examples include inflammatory reaction and tissue changes that cause pain and other quality-of-life-reducing symptoms. Although more data is needed, it appears that in some the response produces local and systemic signs and symptoms that look like, but do not meet formal criteria for, a recognized autoimmune disease.
Symptoms, while uncommon, often don’t occur until several years after implantation and may either be limited to the implant site or more generalized.
The type, duration, and magnitude of the response may vary from patient to patient and is likely to be impacted by factors including, but not limited to:
- Genetics
- Clinical comorbidities
- Simultaneous therapies/medications
- Lifestyle and behavior (e.g., smoking)
Implant material, location, and length of implantation may also influence whether symptoms are seen and whether an acute or chronic response occurs.
Gaps in manufacturer reporting
On March 18, the FDA issued warning letters to the largest breast implant manufacturers, Mentor Worldwide LLC and Sientra, Inc. for failure to conduct adequate long-term studies assessing the safety and risks of their silicone gel-filled breast implants.
This was part of both companies pre-market approval agreement.
The warning letters were based on the manufacturers’ low recruitment low follow-up rates, and poor data. Mentor specifically had deficiencies in the study of their MemoryShape breast implant, which was approved in 2013.
The company failed to enroll the required amount of patients for the study, missed data regarding race and ethnicity, and didn’t properly account for patients.
Last year, Sientra announced that new data showed its “growing portfolio of implants and expanders as safe and innovative options for surgeons and patients undergoing aesthetic or reconstructive breast surgery.”
However, Sientra’s warning letter questioned a study of their approved 2013 silicone gel breast implants, saying their follow-up rate of 61 percent was below the target set.
The administration cautioned that the devices could be taken off the market if they don’t comply and noted that post-approval studies, along with registries, adverse event reports, and scientific literature are critical to monitoring device effectiveness and ensuring patient safety.
After the warning, Mentor said in a statement, "nothing is more important to Mentor than the health and safety of the women who choose our breast implants and Mentor conducts long-term clinical studies to monitor the safety and performance of our products."
The third major US manufacturer of breast implants (Allergan) did not receive any warnings from the FDA,
The use of registries in breast implant surveillance
The FDA is working with the Plastic Surgery Foundation and breast implant manufacturers to develop the National Breast Implant Registry, which was established in 2018 to provide a platform for examining real-world data on the safety and efficacy of breast implants.
The registry—a “prospective, non-interventional, population-based, outcomes and safety surveillance registry and quality improvement initiative,” according to the NBIR description—seeks to improve post-marketing surveillance as the database collects clinical, procedural and outcomes data at the time of breast augmentation and any following reoperations.
What you should know about breast implant illness?
There are more than 300,000 women who have a breast augmentation every year, and most have no adverse reactions.
If you have breast implants and no symptoms:
Keep loving your implants, but do be aware that breast implants are not lifetime devices and as they age the risk for rupture and other complications are greater.
- Get your doctor-recommended MRI. For silicone breast implants this is 3 years after implantation and every two years thereafter.
- Perform your monthly self-breast exam to look for breast changes like lumps, hardening, and dimpling.
- Consider replacing your implants if they’re between the 7- to 10-year mark.
If you have breast implants and unexplained symptoms:
The FDA requests that anyone who has an implantable device report any injury, adverse event or symptoms to the FDA, by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Include the device brand name, manufacturer's name, and details of the adverse event, as well as any medical interventions applied.
A word to our readers
Here at JustBreastImplants.com, we love implants and all the benefits that our readers and community members derive from having them.
The American Society of Plastic Surgeons (ASPS) consistently reports high satisfaction rates among women who choose to have breast augmentation, but for those who do experience complications (especially those unforeseen until recently), we are grateful for a clearer path forward through the FDA's acknowledgment of BII and additional safety recommendations.
We support all women in making informed decisions about what is best for their individual physical and emotional health, within the context of doctor recommendations and safety guidelines.
To connect with other women who are considering breast implants, who have scheduled their surgeries, or who are already enjoying their new and improved boobs, visit the JustBreastImplants Forum or our Private Facebook group. Search Facebook for Just Breast Implants Chat! Support Group for Breast Augmentation to find us there!
References
FDA Executive Summary: Breast Implant Special Topics. (2019). U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM634147.pdf
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on Efforts to Evaluate Materials in Medical Devices to Address Potential Safety Questions. (2019). U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633602.htm
FDA Issues Warning Letters to Two Breast Implant Manufacturers for Failure to Comply with Post-Approval Study Requirements. (2019). U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633890.htm
Risks of Breast Implants. (updated March 22, 2019). U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm064106.htm
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). (updated March 22, 2019). U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239995.htm
Zuckerman D, Srinivasan V. Breast Implant Illnesses: What's the Evidence? National Center for Health Research. Retrieved from https://www.center4research.org/breast-implant-illnesses-whats-evidence/
2018 National Plastic Surgery Statistics. (2018). American Society of Plastic Surgeons. Retrieved from https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-report-2018.pdf
Sientra Reports the Long-Term Safety and Effectiveness of Silicone Gel Breast Implants with Results from the Largest Core Breast Implant Trial To-Date. (2018). Sientra. Retrieved from http://sientra.com/pressrelease?name=4/02/2018
Mentor Statement Regarding FDA Post-Approval Study Warning Letter. (2019). Mentor. Retrieved from http://www.mentorwwllc.com/global-us/FileDownload.ashx?q=D7CB4FFFED6357F1BAD97F3757878A977CD32378&i=190937
