Breast Implants – Why Should All PIP Breast Implants Be Removed?

Breast Implants – Why Should All PIP Breast Implants Be Removed?

Following a meeting of an expert committee on the use of PIP implants in breast augmentation, the French Minister of Health, Xavier Bertrand, decided to recommend the systematic removal and replacement of these implants for all patients, whether or not they show signs of rupture.

I fully support this decision, and here’s why:

1. Serious Manufacturing Deficiencies

There were major deficiencies in the manufacturing and quality control of the PIP breast implant shell. The shell is supposed to include three layers of silicone elastomer, one of which is a barrier layer designed to prevent silicone gel from seeping through the implant envelope.

PIP laboratories reportedly removed this critical barrier layer and failed to conduct proper testing for envelope resistance and durability. As a result, the rupture rate for these implants is abnormally high: 15% to 30% at five years, compared to less than 3% for standard, validated implants.

2. Use of Industrial Gel Instead of Medical-Grade Silicone

What’s more concerning is that the silicone gel used in PIP implants was industrial-grade, not approved for medical use. Unlike cohesive medical-grade gels used in validated implants, this industrial silicone lacks stability and tends to diffuse once the envelope is compromised.

Numerous cases of “siliconomas”—the migration of liquid silicone into the body (axillary lymph nodes, ribs, back, etc.)—have been documented. The surgical management of these complications is extremely challenging and can leave significant after-effects.

3. Cancer Risk Not Evident, But Complications Are Serious

To date, there is no evidence that PIP implants increase the risk of breast cancer or lymphoma. However, it is the risk of siliconomas and the potential severity of their complications that justifies this proactive decision.

4. A Clear Benefit-Risk Assessment

• If the implant is intact: Removal involves a 30-minute, low-risk procedure, typically with no long-term side effects.
• If the implant is ruptured: Surgery can last 2 to 3 hours, carries more surgical risk, and can result in lasting complications.

The benefit-risk balance clearly favors preventive removal, even in asymptomatic patients.

5. Financial Support and Access to Care

Health insurance in France is mobilizing to handle this public health crisis:

• Full coverage for implant replacement in patients whose original implants were reimbursed for medical reasons (breast cancer, aplasia, major asymmetry).
• Full removal costs are covered for patients with implants placed for aesthetic purposes (replacement not reimbursed).

French plastic surgeons are committed to:

• Reducing their fees to make surgery more accessible.
• Offering priority care in public hospitals (e.g., Georges Pompidou European Hospital, Paris) for women in financial hardship.
• Ensuring a coordinated, equitable response across public and private sectors.

6. National Support Resources

A dedicated hotline has been established for patients:
📞 0800 636 636For more practical guidance and information, please refer to the DGS report on the ANSM website.