FDA Warning about Breast Implants Raises an Alarming Concern

FDA warning about breast implants has raised an alarming concern as breast implants are popular among breast cancer patients besides women undergoing breast enhancement surgeries. Refer to the blog to know more details regarding this.

As of September 1^st 2022, FDA received two dozen reports of different types of cancers probably being caused by breast implants. They have released warning immediately in this regard urging patients undergoing breast implant surgeries and physicians undertaking them to be cautious about the development of different forms of cancer in the scar tissue.

Here is a summary of the number of reports the FDA received in this regard.

Number of patients	Type of cancer
10 reports	Squamous cell carcinoma (type of skin cancer)
12 reports	Different lymphomas

Even though a probable relationship is noted, it is not entirely confirmed as adequate information is still not collected by the FDA to confirm the relationship between the cancer type & implants.

What is FDA’s warning about breast implants?

Binita Ashar, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health has recently confirmed the agency would return with clean information understandable to the public soon.

However, they did report patients who developed swelling, pain, lumps or skin changes during the initial implant surgery were more susceptible to developing or contracting cancer. The FDA; however, already raised a warning 10 years back about breast implant-associated anaplastic large cell lymphoma.

Who takes up breast implants?

1. Mastectomy patients usually undergo implant surgery. Almost 100,000 patients in the US alone go for breast implants after mastectomy.
2. Cosmetic reasons are also associated with 300,000 additional implant placements every year.

Important note about breast implants

Here are some notable facts related to the FDA warning about breast implants:

1. FDA released a boxed warning on implant labels to communicate the risk involved with it on 27^th October 2021.
2. The new label includes the following additions:
3. The warning within a box
4. Outlined risks and benefits in the patient checklist
5. Recommends silicone gel-filled rupture screening
6. Upload device description with device-specific materials clearly mentioned in the list.
7. A patient device card needs to be issued to all taking the implants
8. The recent warning is released wherein FDA confirms an implant can be the cause of more types of cancer than was known earlier.

Other notable diseases reported from implants

People with implants have also reported other diseases like lupus, rheumatoid arthritis, breastfeeding issues and even reproductive issues. However, there is no specific way to prove the relationship.

Joint pain, myalgia, chronic fatigue and confusion, autoimmune diseases and many other issues have also come up meanwhile that are linked to the implants.

Which implants are more susceptible?

A question was also raised on the type of implant causing major challenges. Researchers have confirmed that textured implants are more susceptible to causing anaplastic large cell lymphoma. The primary reason cited is their rough textured surface which can cause more inflammation compared to smooth textures.

However, the FDA warning about breast implants revolves around all types for now until further investigations including the ones with smooth and textured surfaces or those filled with silicone and saline.

How many types of breast implants exist in the market?

There are primarily two types of implants around which you can find the current FDA warning about breast implants.

• Silicone filled implants with the outer cover made of silicone
• Saline filled implants with silicone outer shell

Good practices to follow for patients undergoing breast implant surgery

FDA has already notified in the past about non-Hodgkin’s lymphoma (breast implant associated anaplastic large cell lymphoma) linked with breast implants. BIA-ALCL develops more in patients with textured implants. A recent information release shows a more damaging outcome of implants.

A few best practices that patients must discuss with their physicians include the following.

1. Discuss with your clinician if you have a loss of sensation or symmetry.
2. Even if the implants contract, you need to inform the same to your physician.
3. Pain or tightening of scar tissue around the implant needs to be checked with the consulting oncologist.
4. Implant ruptures and leaks will need to get reported to the consulting physician.
5. Monitor your breast implants closely.
6. Anything you ever suspect should be reported immediately to the consultant.
7. Learn to understand the product labeling carefully.
8. Breast implants are not regular lifetime devices.
9. There might be a need for additional surgeries when a patient is having a breast implant.

Conclusion

The FDA’s warning about breast implant is not prohibiting patients from using breast implants based on the current findings. However, they will be investigating the matter more to find out if implants are causing diseases only in a specific population or affecting everyone who undergoes breast implantation.

Also Read: Vaccine to Prevent Cervical Cancer in India Developed Indigenously Ready for December Launch