Biomaterials in breast implant design and applications

Breast Implants

Running Page: THE TECHNIQUE of CHOICE

Biomaterials (Breast Implants)

A biomaterial is any natural or man-made material, which forms part or whole of a living structure or biomedical device, and meant to perform, complement or replace a natural function (San Jose State University, 2009). Biomaterials fall under physical, biological and chemical sciences and their clinical disciplines (Biomaterials International Journal, 2011). These sciences span polymer synthesis and characterization, drug and gene vector design, the biology of the host response, immunology and toxicology and self-assembly at the nanoscale. Biomaterials are used as therapies of medical technology and regenerative medicine in all clinical disciplines and diagnostic systems, which rely on innovative contract and sensing agents (Biomaterials International Journal). Silicone is the biomaterial used in many biomedical applications, popularly breast implants for breast reconstruction.

Breast Reconstruction

Most women undergoing mastectomy may opt for breast reconstruction, such as breast implants and latissimus dorsi flaps (Fentiman & Hamed, 2006). The more sophisticated is the transverse rectus abdominis myocutaneous or TRAM flap-based reconstruction as an immediate reconstruction performed by plastic surgeons. The technique depends on the patient's body build, coexisting medical conditions and probable need for postoperative radiotherapy as part of treatment. A patient should have a realistic expectation of the outcome, which is that the reconstructed breast will neither feel nor function as a normal breast. It will only help restore body contours and personal confidence (Fentiman & Hamed).

Breast Implants for Reconstruction

This involves inserting an inflatable implant into the submuscular pocket (Fentiman & Hamed, 2006). The implant material is inflated during surgery. In the succeeding weeks, it is gradually expanded with normal saline until the desired volume is reached. It is temporarily over-expanded in order to produce ptosis. The aim is to bring the reconstruction to match the untreated breast as closely as possible (Fentiman & Hamed).

Current Technique for Breast Implants

This requires more than one operation and extends to many months (Shons & Mosiello, 2001). Breast implants are the choice of as many as three-fourths of patients. It begins with the placing of tissue expander below the pectoralis muscle and laterally below the anterior of the serratus anterior muscle. The tissue expander is a saline-filled container into which saline can be added in stages after the implant surgery. Some fluid is placed into it at the time of insertion. The patient usually stays in the hospital overnight in case of immediate reconstruction. Delayed reconstruction is performed on an outpatient basis after mastectomy (Shons & Mosiello).

Healing is expected to complete in 3 to 4 weeks from surgery (Shons & Mosiello, 2001). Volumes of saline at 60 mL per visit are added usually on a weekly basis. The tissue expander is removed. Permanent implant is performed at least three months after or upon the completion of chemotherapy. The tissue expander is removed and the permanent implant placed on an outpatient basis. The permanent implant may be filled with saline or silicone gel. The U.S. Food and Drug Administration restricted the use of silicone gel-filled implants for breast augmentation in 1992. Since then, they have been available only under protocol from companies and only for reconstructive purposes (Shons & Mosiello).

A case study is a professional woman who undergoes breast implant surgery in order to have a shapely figure (Virginia Breast, 2009). She works out and lifts weights and wants a naturally shapely look. She is 36 years old, 5'6" high and weighs 117 pounds. Her precup size is 34A, new cup size is 34D and implant size is 275 cc (Virginia Breast).

Complexities

One major problem is that implants may induce strong fibrous reaction to capsular contracture, which produces pain and an abnormal shape (Fentiman & Hamed, 2006). This is likelier to form in women with smooth than those with textured implants, according to studies. Another major concern is that breast implants may hide breast cancers, induce them or increase the risk of connective tissue disorders. Two separate studies found these concerns to be untrue. One was a case-control study of 23 women who developed breast cancer following breast augmentation with an implant. A comparison with 11 age-matched controls showed no delayed diagnosis of breast cancer or advancement in women with implants. Another was a follow-up study of 2,174 cases, which showed a likelihood of reduced relative risk at 0.6. A Swedish cohort study of 7,442 women with implants showed no evidence or connection between breast silicone implants and connective tissue disease (Fentiman & Hamed).

Overall complications and complexities associated with breast implants are capsular contracture or implant rupture, leakage, infection, cosmetic flaws, loss or increase of nipple sensation, bleeding or fluid accumulation (Eitenmiller, 2011).

Solutions and Outcomes

A Surveillance, Epidemiology and End-Results Breast Implant Surveillance Study conducted on women who received breast implants following mastectomy showed no survival disadvantage in those younger than 65 years of age (Le et al., 2005). The respondents were from San Francisco-Oakland, Seattle and Iowa between 1983 and 1989. The risk of mortality with breast implants following mastectomy is about half for those without implants. Breast implants continue to be the choice form of breast reconstruction among breast cancer patients. There has been no significant change in design despite an overall decrease in implant use among them (Le et al.).

The solution should be improvement rather than perfection (Eitenmiller, 2011). Complications in women undergoing reconstructive surgery after a diagnosis of breast cancer are substantially larger. Silicone implants have become available again but carry a higher failure rate than saline. The U.S. FDA still questions their long-term complications, however. Patients should then consider the potential complications and locate a board-certified physician, place costs aside, and plan for surgeries when deciding for breast augmentation (Eitenmiller).

Alternative to Silicone Gel Breast Implants

The major concern for allowing silicone gel breast implants on the market in 1992 was to keep the option open for mastectomy patients (Zuckerman, 2001). However, the majority of women getting mastectomies rather than breast-conserving surgery went down substantially. Instead, the preference for autologous tissue transfer far outnumbered implants. The FDA approved saline-filled breast implants in 2000. Since then, saline implants became the most sought-after alternative to silicone gel for implants after these were restricted in the early 1990s (Zuckerman).

IOM Report

The Institute of Medicine reported that local complications are the major concerns in breast implants (Zuckerman, 2001). These range from minor to serious. Infections can be easily managed or cause toxic shock syndrome, which in turn can result in gangrene or death. The most common complications are scarring, asymmetry, loss of sensation, pain, hardness, and the need for additional surgery. These are not fatal but affect quality of life and contradict the purpose of breast implant surgery (Zuckerman).