Is There a Real Risk of Developing Scleroderma After Receiving Silicone Breast Implants?

Any surgical procedure, including breast implants, carries certain risks. When considering silicone breast implants, one concern that often arises is the possibility of developing scleroderma, a rare autoimmune disease characterized by hardening of the skin and connective tissues.

Understanding the FDA Study

The question of whether silicone breast implants pose a risk for developing scleroderma has been addressed through comprehensive studies conducted by the FDA. One such study, the Allergan Large Study, is often cited. This study was required by the FDA and involved an extensive examination of silicone gel-filled breast implant participants. Here are the key findings:

Rare Outcomes in the Allergan Large Study

According to the study, 0.6 percent of silicone gel-filled breast implant participants and 0.4 percent of saline breast implant participants had new reports of connective tissue disease (CTD) at the two-year follow-up. Specifically:

9 women reported fibromyalgia. 4 women reported rheumatoid arthritis. 9 women reported fibromyalgia. 3 women reported systemic lupus erythematosus. 27 women reported miscellaneous undifferentiated, unspecified, or "other" CTDs.

Of the participants with silicone gel-filled implants, 1.2 percent (80 women) reported a diagnosis of any cancer post-implantation. Additionally, 0.3 percent (3 women) experienced neurological disorders.

Review of the Mentor Large Study

The Mentor Large Study provided further insights into the potential risks associated with silicone breast implants. This study focused on the incidence rates per 10,000 person-years for various conditions, including connective tissue disorders (CTDs) and cancers. Here are the detailed findings:

Incidence Rates for Various Conditions

At a three-year follow-up:

Rheumatoid arthritis: 27.2 per 10,000 person-years (83 new cases). Osteoarthritis: 70.9 per 10,000 person-years (210 new cases). Scleroderma: 3.9 per 10,000 person-years (12 new cases). Systemic lupus erythematosus: 4.2 per 10,000 person-years (13 new cases). Sj?gren’s Syndrome: 5.9 per 10,000 person-years (18 new cases). Other connective tissue diseases: 22.4 per 10,000 person-years (68 new cases). Fibromyalgia: 26.4 per 10,000 person-years (80 new cases).

The study also noted the incidence rates for newly diagnosed cancer, with:

59.7 per 10,000 person-years (136 new cases) for all types of cancer. 13.6 per 10,000 person-years (31 new cases) for breast cancer. 0.9 per 10,000 person-years (2 new cases) for lung cancer. 0.0 per 10,000 person-years (0 new cases) for brain cancer. 45.2 per 10,000 person-years (103 new cases) for other cancers.

For neurological disorders, the incidence rate was 36.0 per 10,000 person-years (111 new cases).

Educating Yourself Before Implantation

Considering the risks and benefits of silicone breast implants, it is crucial to inform yourself adequately. The 2011 case study requirements by the FDA emphasize the importance of transparency. Board-certified doctors, who are legally bound to disclose all relevant information, can provide valuable insights.

Alternative Methods for Breast Enlargement

For those seeking to increase their breast size, it's worth noting that there are alternative methods such as exercises and dietary changes. While these methods may not be as effective or immediate as implants, they can offer natural and less invasive means to enhance breast size.

Natural Methods for Breast Enlargement

Our wife's experience, which resulted in a noticeable size increase after following a specific tutorial, can serve as an inspiring example. While these methods may not provide the same immediate and dramatic changes as implants, they offer a safer and more natural approach. It's always advisable to consult with a healthcare professional for personalized advice and guidance.

In conclusion, while the risk of developing scleroderma after receiving silicone breast implants is rare, it's essential to weigh the potential benefits against the risks and to consult with medical professionals to make an informed decision.