CHAPTER 55 Cohesive gel breast augmentation

History

Form-stable cohesive gel implants are currently available in the US only through FDA PMA (premarket approval) clinical trials; however, they have been available internationally since 1993. There has been some confusion regarding what actually is a cohesive gel implant. Although all implant fillers are cohesive in the physical sense (saline or gel) the reality is that the term cohesive gel implant has traditionally meant a form-stable device (i.e. Inamed 410, Mentor CPG). The distinction is cogent as the benefits of form-stable implants that have been realized to date are a direct function of the form stability of the filler. Thus, surgeons and patients must understand these important differences.¹^–³

What we do know is that these new form-stable cohesive gel implants have been used internationally for over 12 years and have a significant market share for aesthetic and reconstructive breast surgery. These implants may be available in the US as soon as 2009 and will provide patients and surgeons with the ability of enhanced outcome and results if used properly; however there will need to be a transition from the smooth round saline thought process to a more comprehensive approach for the typical US plastic surgeon.

Physical evaluation

Success with these more advanced devices will require redefining how most US plastic surgeons approach both aesthetic and reconstructive breast surgery.

Although 5th generation devices allow enhanced results, the real advances in breast augmentation are not about the implant. The techniques that have been used with good success with these new devices do help minimize problems and optimize outcomes with any implant.

Breast augmentation is a process, and includes the following important components:

1. Patient education and informed consent.

2. Tissue-based clinical planning.

3. Refined, systematic surgical technique.

4. Defined postoperative management.

These four components are essential to perform consistently in every breast augmentation patient, and to optimize outcomes. The goal is to maximize quality/outcome for the patient and minimize reoperation rates.

The data to support this process include independently published, peer-reviewed series and presented series at national meetings.⁴^–⁹ All include reoperation rates of 3% or less (compared to the standard 15–20% from PMA studies over the past 15 years).

• Patient education is the most essential of all, and should give patients ample time through written material and patient educator sessions to define on paper what their expectations are.

• This is followed by a surgeon’s consultation, to perform tissue-based implant selection and compare this to the desires which the patient defined during the education portion. Any discrepancies are reconciled and the patient is able to make final choices based on the comprehensive knowledge provided.

• Tissue-based clinical planning is performed with the High 5 Process.¹⁰ This is a refinement of previous generation planning systems and allows the surgeon to focus on the five critical decisions that determine outcomes in breast augmentation.

• The five decisions determined are:

1. Pocket plane – determined to optimize long-term coverage. Dual plane techniques have been used for 98% of cohesive gel primary augmentations in this series, although other pocket planes have also been frequently used including subglandular and subfascial planes.

2. Implant volume is selected using the High 5 process principles. The most important measurement is the breast width (see Fig. 55.1). Then the breast tissue type is characterized by the skin stretch and the existing fill to determine the final recommended volume.

3. Based on this information the size and type of implant are selected.

4. IMF position is planned based on the selected implant and the individual tissue characteristics of the breast.

5. The incision is selected. Form-stable cohesive gel implants can be placed via all three standard incisions; however, the majority of cases have been done via the inframammary approach, as this has enhanced control with the pocket dissection and implant placement. The cosmesis of a properly planned inframammary incision is excellent.

• The goal is to have all key decisions made during the consultation and prior to going to the operating room.

Technical steps

The patient is marked in the preoperative area (Fig. 55.1). The planned width and height of the selected implant are marked on the chest wall skin to facilitate the dissection and the incision is planned. Full general anesthesia with short-acting muscle paralysis is used. After induction, 2–3 mL of 1% lidocaine with epinephrine is injected in each incision to minimize skin bleeding. After standard prep and drape the nipple areolar complexes are covered with a small sterile tegaderm. The paradigm and principles for pocket dissection have changed from non-precise, blunt and bloody to a planned, precise, atraumatic dissection under direct vision. The instruments that facilitate this dissection are:

1. Good quality headlight.

2. A double armed retractor.

3. A non-toothed medium lighted retractor.

4. A implant spatula.

5. Hand switching electrocautery.