During consultation, questions often arise as to which implants will be best for the patient, silicone vs. saline. Although both implants are still available, FDA has still restricted the use of silicone gel implants to women who meet specific criteria.
In the United States, both Mentor and Inamed provide FDA approved silicone gel implants for women who meet the specific criteria. This specific inclusion criteria, according to mentor’s adjunct study, is that the patient be female, that the patient be willing to follow the study requirements and that the patient must have at least one or more of the specific indications, including 1) postmastectomy for cancer reconstruction; 2) a severe deformity which can include status post traumatic or a congenital deformity, including pectus carinatum excavatum tubular breast deformity or severe asymmetry such as in Poland syndrome, or finally breast ptosis, meaning sagginess to the breast which requires some form of mastopexy or breast lift. Final criteria can include replacement or revision from either reconstruction from breast or breast augmentation in which silicone gel implants were used previously.
There are exclusion criteria as well, which can be found on the Mentor Preoperative Patient History Record. These include the patient having any history at this time of an abscess or infection anywhere in the body. If the patient is pregnant or nursing, they are excluded from the study. If the patient has any symptoms of diagnoses of lupus or scleroderma, uncontrolled diabetes, tissue that is incapable of handling the silicone gel implant, including radiated tissue or psychological reasons.
If a patient meets any of the criteria as described above and the patient has a desire to either add silicone gel implants and/or continue with them after replacement, then the patient will need to fill out with the plastic surgeon the entire informed consent.
The informed consent will include specific details which will mark out the risks and complications associated with the surgery. These will include infection, hematoma or collection of blood, serous fluid collection (seroma), capsular contracture with scar tissue formation as well as anesthetic risks. Capsular contracture can occur with either silicone or saline and may require removal of the scar tissue, referred to as a capsulectomy, or release of the scar tissue (capsulotomy) in order to allow more volume space and room for the implant to move.
Silicone implants may deflate, rupture or leak and may require replacement. They may be more difficult to detect because although there is a rupture of the intracapsular shell, it may not be detected for many years. Mammograms and even ultrasound may not detect the rupture and an MRI may be required in order to get a more definitive answer. Extracapsular silicone migration can occur as well as this may lead to free silicone which migrates to the lymph nodes under the armpit or the axillary lymph nodes or into other parts of the body. If an implant is ruptured, it should be removed as soon as possible. Increased scar tissue formation certainly may occur as well as migration of the silicone gel to different parts of the body.
Other complications associated with silicone gel implants, include silicone gel bleed. This is simply the oil of the silicone migrating through small micro pores within the shell, which may bleed through and be trapped within the scar tissue around the implant. This may increase calcifications. Mammography interference and difficulty in detecting calcifications versus cancer may also be associated with silicone gel implants, especially when placed in the retromammary pocket (above the pectoralis major muscle).
In contrast, saline implants may be more user friendly in that 1) we’re able to change the fill volumes of these implants with women who have asymmetric breasts are able to titrate the volumes of the implants to even out the breasts to make them more symmetric. Saline implants also if they shall rupture are an all or none phenomenon and within several weeks it will be quite apparent that the implant is deflated. The fluid from a saline implant when placed preoperatively in a sterile environment will be absorbed or resorbed and should yield no harmful effects to the patient.
Capsular contracture certainly can occur with saline implants, although in my practice I have found it to be less likely than silicone gel, as there is no silicone gel bleed with saline implants.
In the future, silicone gel implants may be available to the general public. At this time, it is still under FDA review and although the advisor panels have approved the silicone gel implants to be reviewed by the FDA, there is no definitive answer at this time. In general, as in any surgery, the use of silicone versus saline implants must be tailored to the needs and specifics of each individual. It is important to choose the specific implant carefully. The patient once again needs to be included within the criteria outlined by Mentor and/or Inamed Corporation in the United States of America.