IN THIS LESSON

Learn about what the FDA says about Toxicology testing on Breast Implants.

According to the FDA "Breast Implants -Certain Labeling Recommendations to Improve Patient Communication Guidance for Industry and Food and Drug Administration Staff" (issued Sept 29, 2020), each pair of implants are required to have a Black Box Warning Label:

What are in Breast Implants?

Ref: https://www.ncbi.nlm.nih.gov/books/NBK44789/

"Breast Implants -Certain Labeling Recommendations to Improve Patient Communication Guidance for Industry and Food and Drug Administration Staff"

Here are links to understand some of the chemicals comprised in breast implants:

-Dimethyl Silicone Elastomer Dispersion

-Silicone Toxicology: Scope and Criteria for the Toxicology Review

Toxicology Data for Breast Implants:

According to the FDA, Breast Implant materials consist of Chemical Polymers, Heavy Metals, and Solvents. They recommend toxicology testing be done by the surgeon on each Breast Implant BEFORE surgery is performed.

Lets discuss the recommended Toxicology Data for Breast Implants...........

Toxicology Data

A. General Information

"We recommend you (surgeon) provide a toxicological assessment because breast implants contain not only the major polymeric materials (e.g., polymerized polydimethylsiloxane), but also low molecular weight components (e.g., D4) from the manufacturing or sterilization processes that may leach out into the patient’s body. In addition to the chemical composition information, the toxicological safety assessment should include information from pharmacokinetic studies and toxicological testing."

Ref: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants

The FDA suggests that surgeons do toxicological testing on Breast Implants. They warn that the chemicals used to sterilize and make implants may release into your body and could potentially cause issues. The testing would be done before surgery.

B. Pharmacokinetic Studies

"Knowledge of the potentially toxic chemicals to accumulate in the body at concentrations that cause human health risks. The pharmacokinetic testing of toxins of concern should determine the rates of absorption into and clearance from the blood, the distribution in the body, and the rates of metabolism and/or excretion."

For additional information about pharmacokinetics, refer to ISO 10993-16.5

This means you should be tested to see how long chemicals stay in your body as well as how quickly your system can get rid of toxins. These are important blood tests to determine how your body will respond to Breast Implant chemicals. It is possible that these chemicals may be released into your blood stream after surgery.

C. Toxicological Testing

"Toxicological testing is used to detect unidentified toxicants and to quantify the exposure to known toxic compounds. We recommend you (surgeon) perform the following toxicological tests separately on both the final sterilized shell and filler."

Recommended Tests:

• cytotoxicity

• acute systemic toxicity

• hemocompatibility

• immunotoxicity

• reproductive toxicity

• teratogenicity

• genotoxicity

• carcinogenicity

• implantation testing

Ref: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants

There are 9 different toxicological tests the FDA recommends for Breast Implants. Surgeons using this guideline have your best interest in mind. These tests may show if the Breast Implants are safe, and if you will have a reaction to the chemicals or materials in Breast Implants.

Let’s discuss some of the 9 mentioned tests.......

Breast Implant Toxicological Testing

Acute Systemic Toxicity

"For Acute Systemic Toxicity testing, we (FDA) recommend that you (surgeon) performs both the rabbit pyrogen and LAL tests. This involves an assessment of the toxic effects of a single dose or multiple doses of a chemical by oral, dermal, or inhalation. Rabbits are exposed to the test substance for a minimum of four (4) hours and are then monitored for a period of 14-days. Animals that die during the study are autopsied."

Ref: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6117820/#:~:text=Acute%20toxicity%20test%20for%20inhalation,during%20the%20study%20are%20autopsied.

Immunotoxicity Testing

"For immunotoxicity testing, we recommend you assess the level of immunotoxicity of the shell and any leachable compounds from the shell and the gel (if applicable). Immunotoxicity testing uses a range of in vitro and in vivo (blood) testing for evaluating the potential of environmental and occupational substances to alter the function of the immune system."

Ref: https://ntp.niehs.nih.gov/whatwestudy/testpgm/immtox#:~:text=Immunotoxicity%20Studies,Natural%20products%20such%20as%20mycotoxins

Reproductive and Teratogenicity Testing

"For reproductive and teratogenicity testing, you should measure the rates of conception, maturation, and cycling abnormalities, as well as the number of fetal deaths and malformations. The studies should include at least two generations. You should test the chemicals at the HIGHEST possible exposure that does not cause system toxicity."

Ref: Schumann J. Teratogen screening: state of the art. Avicenna J Med Biotechnol. 2010 Jul;2(3):115-21. PMID: 23408063; PMCID: PMC3558154. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3558154/

This test is for those who want to become pregnant or nurse after having Breast Implants. Researchers may use Zebra fish to determine if the chemicals in your implants may cause birth defects.

Genotoxicity Testing

"For genotoxicity testing, you should address the potential of leachable compounds of your device (breast implants) to cause cancer. The short-term genotoxicity testing should consist of:

• a bacterial mutation test

• a mouse lymphoma test

• an in-vivo (live) mouse micronucleus test

The point of this test is to assess the possibility of mutations or chromosomal abnormality that could arise due to the use of chemicals."

Ref: https://www.sciencedirect.com/topics/medicine-and-dentistry/genotoxicity-assay

This test will show the potential of Breast Implant chemicals changing your DNA. Your surgeon may order a blood or tissue test to see you will have an increased risk for mutations.

Implantation Testing

"We (FDA) recommend you (surgeon) provide acute, subchronic, and chronic implantation testing because some implant components (i.e. chemicals) may have immediate tissue reactions, while others may diffuse out of the device slowly and affect the surrounding tissues long after implantation. You should implant samples of shell and gel, subcutaneously or submuscularly."

Ref: https://www.sciencedirect.com/topics/engineering/implantation-test

This means the FDA wants the surgeon to place a small piece of the shell and or gel inside your body before surgery to see if you will have a negative reaction.

What are the Risks of Breast Implants?

According to the FDA, the following are Risks of Breast Implants:

1• cancer (both breast and non-breast)

2• benign breast disease

3• Connective Tissue Diseases, signs, and symptoms, including fibromyalgia

4• interference of device with mammographic detection of tumors or rupture

5• neurological disease

6• inability to lactate

7• offspring issues (safety of milk for breastfeeding and 2nd generation effects)

8• potential systemic health consequences of extracapsular and migrated gel rupture

9• potential health consequences of gel bleed

10• depression, anxiety, and suicide.

11• rheumatic diseases – such as rheumatoid arthritis, systemic lupus erythematosus, discoid lupus, scleroderma, vasculitis, polymyositis, and dermatomyositis

12• rheumatic syndromes – such as Raynaud’s phenomenon, Sjogren’s syndrome, CREST syndrome, morphea, carpal tunnel syndrome, multiple sclerosis-like syndrome, multiple myeloma-like syndrome, chronic fatigue syndrome, and fibromyalgia.

Ref: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants

I experienced 9 out of the 12 Risks associated with Breast Implants.

Let's talk about Complications of Breast Implants:

According to the FDA, the following are Complications of Breast Implants:
D. Safety Assessment – Complications

1• rupture

2• capsular contracture (include Baker Grade)

3• infection

4• calcification

5• malposition

6• extrusion

7• skin erosion

8• necrosis

9• lymphadenopathy

10• delayed wound healing

11• breast/chest/axillary mass formation

12• hematoma

13• seroma

14• pain

15• wrinkling

16• asymmetry

17• scar formation

18• palpability/visibility of the device

19• iatrogenic injury, etc

20• alterations in nipple or breast sensation

21• interference and/or difficulties with lactation, as well as the frequency of attempted lactation without success

22• difficulties with pregnancy

23• patient deaths

24• breast cancer diagnosis post-implantation, mammographic difficulties/interference caused by the device

25• new connective tissue disease (CTD) diagnoses, signs, and symptoms.

Ref: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants

I experienced 14 out of the 25 Complications listed above.

Final Thoughts

The information offered in this lesson can be found in the links provided and on the FDA website. The data is medically tested, and patients may experience none, a few, or many of the risks and complications associated with Breast Implants.

If you plan on getting Breast Implants, it may be wise to ask your surgeon about Toxicology testing on your implants, and to explain the risks and complications associated with the type of implants you are getting.

Please feel free to email us if you have any questions. biihealingisreal@gmail.com

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