Are teardrop shaped breast implants still allowed for use in breast augmentation surgery?

Teardrop (Anatomical) Breast Implants Remain Available and Approved for Use

Yes, teardrop-shaped (anatomical) breast implants are still allowed and remain an important option in breast augmentation surgery, though their use requires careful consideration of the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with textured surfaces. 1

Current Regulatory Status and Availability

• Anatomical implants, including form-stable "gummy bear" varieties, are commercially available and FDA-approved for both cosmetic augmentation and reconstructive purposes. 1

• The FDA lifted its moratorium on silicone implants in 2006 after studies evaluating associated malignancies, autoimmune diseases, and other problems did not show a causal relationship to implant placement. 1

• Both anatomical and round implants remain key elements of the surgical toolbox in breast augmentation, with the choice dependent on patient-specific factors. 2, 3

Critical Safety Considerations: BIA-ALCL Risk

The most important caveat is that most reported cases of BIA-ALCL are associated with textured implants, which are commonly used for anatomical devices to prevent rotation. 1, 4

• BIA-ALCL typically presents 8-10 years following implantation with delayed peri-implant effusion (>1 year after surgery). 1, 4

• The FDA announced the association between breast implants and ALCL in 2011, and in 2019 recommended a boxed warning on breast implant labeling and a standardized informed consent checklist. 1, 4

• Smooth anatomical implants with fixation systems have emerged as an alternative to traditional textured anatomical implants, offering rotation prevention without the higher surface roughness associated with BIA-ALCL risk. 5

Clinical Indications for Anatomical Implants

Anatomical implants offer specific advantages in certain clinical scenarios where round implants may produce suboptimal results:

• Patients with glandular ptosis and nipple placement below the inframammary fold can achieve nipple elevation without mastopexy in 92.9% of cases using high-projection anatomical implants. 6

• Anatomical devices provide increased flexibility in matching patient anatomy and desires, with a wider range of dimensional options. 2, 3

• Clear indications exist for using anatomical devices in specific patients based on anatomy, surgical history, and aesthetic goals. 2, 3

Rotation Risk and Technical Considerations

• The rotation risk with microtextured anatomical implants is approximately 2.6-3.2%, similar to macrotextured implants. 6

• Rotation concerns can be minimized with proper patient selection and surgical technique. 2

• Smooth anatomical implants with tab fixation systems demonstrate rotation in only 1.6% of cases (2 of 122 patients), with no cases of capsular contracture, seroma, rupture, infection, or hematoma. 5

Mandatory Patient Counseling and Monitoring

The FDA requires specific informed consent discussions covering:

• Risks of BIA-ALCL, particularly with textured implants 1, 4
• Systemic symptoms and breast implant-specific risks 1
• Recommended surveillance: initial ultrasound or MRI at 5-6 years after implant surgery, then every 2-3 years thereafter 1, 7

Practical Algorithm for Implant Selection

When considering anatomical versus round implants:

1. Assess patient anatomy, particularly presence of glandular ptosis and nipple position relative to inframammary fold 6
2. Strongly favor smooth anatomical implants with fixation systems over textured varieties to minimize BIA-ALCL risk 4, 5
3. Consider anatomical implants when specific dimensional requirements or ptosis correction without mastopexy is desired 2, 3, 6
4. Ensure patient understands longer learning curve for surgeons and importance of proper technique 2
5. Document comprehensive informed consent including BIA-ALCL risks and long-term monitoring requirements 1, 4