Legal Dilemma in Medical Law on Breast Implants

TABLE OF CONTENT

CHAPTER ONE: INTRODUCTION
Acknowledgments
Abstract
1.1 Background to the Study
1.2 Saline Implants: Surgical Technology and Technique
1.3 Silicone-gel Implants
1.4 Research Problem
1.5 Purpose of Study
1.6 Significance of the Study
1.7 Research Questions
1.8 Organization of Chapters

CHAPTER TWO: REVIEW OF LITERATURE
2.1 Introduction
2.2 Benefits of Breast Implants
2.3 Complications of Breast Implants
2.4 Breast Implants and Effect on Breast-Feeding Mothers and Children
2.5 Summary

CHAPTER THREE: CURRENT ISSUES OF FAULTY BREAST IMPLANTS
3.1 Introduction
3.2 Issues Surrounding the Faulty Breast Implants in the UK
3.3 Some Comments from Recipients of PIP Breast Implants
3.4 More Information on the Issue of the Faulty Breast Implant
3.5 Durability of the PIP Implants
3.6 Number of Women Affected by the PIP Implant
3.7 NHS Vs Private Clinic PIP Implant
3.8 Evidence on PIP Implant Safety
3.9 Signs of Rupture of Breast Implants
3.10 Mechanism that Exist to Regulate the Use of Medical Implants and Devices

CHAPTER FOUR: SUMMARY AND CONCLUSION
4.1 Summary
4.2 Conclusion

REFERENCES

CHAPTER ONE INTRODUCTION

ACKNOWLEDGMENTS

I thank God, for health and life that you have given me to achieve my professional goal.

To Professor Simon Payne, thank you for dedicating your time and motivating me to write a medical legal Topic. Your expertise in this filed was important in development of my ideas. Thank you for excellent recommendations and sharing your expertise to improve my literature in the development of this skill.

ABSTRACT

The issue of faulty breast implant in the United Kingdom has recently been of grave public concern, with panics from women in the United Kingdom concerning implants filled with industrial silicone gel. The paper was guided by four research questions. These research questions include “What are the benefits of PIP breast implants?, What are the complications that may arise from PIP breast implants?, What relations exist between breast implant and certain diseases?, and What went wrong in the recent issues of faulty breast implants in UK women and other women around the world?

1.1 Background to the Study

Breast implants involves a medical prosthesis for correcting the form, size, and feelings derived from the breast of a woman. Women who request for implants may do so under certain circumstances such as; the correction of deformities and congenital defects present on the chest walls, breast reconstruction, augmentation for the sake of beauty and trends, for artificial creation of breast in transgender patients. Three form of devices used for breast implant currently exist and they are saline, silicone, and composite implants. The first type of breast implant mentioned above – saline implant – comprises of a spotlessly clean saline solution filled inside an elastomer silicone shell. The second type of breast implant – silicone implant – comprises of a thick silicone gel filled inside an elastomer silicone shell. Finally, the alternative composition implants is normally carried out with varied fillers, which includes polypropylene string, soy oil, and others. It is important to note that alternative composition implants are no more in use currently, and hence are no more produced.

Breast implantation in surgical practice involves a corrective device consisting of a replacement for the breast and is usually used for tissue expansion to form and create a pocket for permanently implanting a breast. Most women in the United States and the United Kingdom at large, due to one reason or the other have requested for breast implants, which on the long run may or may not become harmful to them. Hence, this paper will critically examine cases of breast implants and the detrimental effects on the women. In order to get a perfect understanding of breast implant and the aim of this study, it is important to briefly elaborate on the types of breast implants and the techniques and technology used to administer them to humans.

1.2 Saline Implants: Surgical Technology and Technique

As mentioned earlier, this type of breast implant deals with filling breast implants with saline solution. Early models of saline implants were very delicate and had great tendencies of failing, usually in the form of prosthesis deflation, saline filler leakage, and breakage of the shell. Due to these reasons, modern models of saline implants are manufactured using stronger technology involving vulcanized shells at room temperature designed with what is known as silicone elastomer. As a result of various studies suggesting that the saline breast implants had considerable amounts of filler leakage, this facilitated the preference of silicone breast implant over saline implants for the purpose of corrective breast surgery (Stevens et al., 2006). However, the saline breast implant was preferable in the 1990s following the United States Food and Drug Administration import restrictions of silicone implants, therefore making it very difficult to access.

The development of the saline breast implant was to make possible a more conventional method that involves slight cuts on the breast, for putting into position an empty implant device via a minor surgical cut or opening (Eisenberg, 2009). In surgical practice, the breast prosthesis inserted into each breast is filled with saline solution through the small incision. Since, the incisions on each breast are small; the scars from the surgery would be smaller, unlike silicone gel implants that require long incisions for the insertion of pre-filled silicone-gel breast implants. Even though it is possible for saline breast implants to produce excellent results in terms of the size of the breast, the feel, and contour of the breast as compared to the resulting feel, contour and size from silicone gel implants, the saline breast implant is more probable to result into complications such as wrinkling, ripping, and artificiality to the eye and when it is touched. Hence, when women seek for breast reconstruction or enlargement, silicone gel implants are the best choice for such women. However, saline breast implants are preferable for women with much breast tissue and those whose surgical technique involves submuscular emplacement.

1.3 Silicone-gel Implants

Medically, silicone-gel implants are classified under five generations, which are defined the model techniques used in their manufacture. The first generation silicone-gel breast implant was known as the Cronin-Gerow Implant. This model was designed in 1963 and consisted “of a silicone rubber envelope shaped like a tear drop” and filled with thick silicone-gel. In order to reduce rotation of the implant, polyethylene terephthalate was used to affix the implant to the back of the implant shell (Cronin & Gerow, 1963). The second generation of silicone-gel implants was however designed in the 1970s and consisted of a device shell and filler for the silicone-gel, which were thinner and of low cohesion respectively, thus improving the practicality and quality of seeming to be true breasts in terms of size, shape, and feel.

However, in clinical praxis, this generation of silicone-gel breast implants proved to be delicate and easily broken, and suffered filler leakage, gel bleed, and shell rupture. The United States government, due to the failures in this second generation silicone-gel breast implants, had no choice than to file a lawsuit against Dow Corning Corporation, and others that were involved in the manufacture of breast prosthetic devices. The implant shell coating of the second generation implant was made of polyurethane foam. This resulted in inflammatory reactions that helped in the reduction of capsular contracture by impeding any form of fibrous collagen tissue capsules to be formed around the implant. Yet, this generation of implant was discontinued due to the health implications of 2,4-toluenediamine (TDA), used in making the coating (Luu, Hutter, & Bushar. 1998).

Furthermore, the third and fourth generations of silicone-gel implants saw limelight in the 1980s. It consisted of shells coated with elastomers that reduced the likeliness of filler leakage, and a thicker filler gel which increased cohesion. Much advancement was made until the fifth and final generation of silicone-gel breast implants came into limelight. In the 1990s, the fifth generation was manufactured. This generation was made of a semi-solid gel that increased cohesion, and hence eliminated gel bleed and migration of silicone from the breast to other parts of the body. Several recent studies reported low rates of capsular contracture, improved safety medically, greater efficacy, and reduced rates of shell rupture, as compared to earlier generations.

Late in 2006, MemoryGel was formulated. This was silicone gel filler with very thick gel implant and this gained FDA approval. The thickness of the silicone gel made the reduction of gel spread possible upon rupture. It also made possible increased scar shrinkage resistance capable of deforming its contour. Even when the filler is cut, the gel doesn’t run as its shape is maintained. According to Brody and Long (2012), “this device has a doughy feel to it.” Both saline and silicone-gel breast implants are available in the United States, and may come with smooth or textured surfaces. These devices come in different shapes such as teardrop and round, with 3 projections. In the United States, Allergen and Mentor Corporation are the only companies allowed to market breast implant devices (Brody & Long, 2012).

1.4 Research Problem

Recent issues of faulty breast implants in UK women and other parts of the world, and lawsuits filed against plastic surgeons and manufacturers of implants have necessitated carrying out this research so that one can know what went wrong in the mechanism of control of breast implants. Following the faulty PIP implants manufactured by a firm in France, rebranded and resold under the name M-Implants, and the number of women in the United Kingdom and other parts of the world, this study seeks to analyze or retrieved necessary information about this happening and discover what went wrong in the manufacture of these implants. The implants were said to be of great global concern due to its high rupture and leakage rate and its toxicity, thereby having every tendency of causing cancer. Different articles and news have displayed information concerning vast number of women seeking refunds and those seeking free removal of faulty implants. Hence, this study will be of great significance.

1.5 Purpose of Study

The rate of influx of women, who come for breast implants in the United States is not known, neither is the number of women who have breast implants in the United States. However, recent estimates from national survey have shown that over 6 million women in the United States have breast implants, a figure which represents above “5 percent of the adult female population” (Brody & Long, 2012). From the yearly data collected by the American Society of Plastic Surgeons on plastic surgery procedures, it was discovered that in the year 2008, nearly 307,000 women had breast implants for enlargement, while 111,000 women had breast implants for reconstruction of deformities following mastectomy or congenital.

It is important to note that this number of women was obtained from only plastic surgeon, whereas the procedure is also performed by gynecologists, general surgeons, otolaryngologists, and others (Brody & Long, 2012). Due to the increasing rate of report of harm following breast implantation, this has called for a study to cover the recent issues of PIP implants in the United Kingdom, including faulty breast implants. This paper will also examine the risk posed by breast implant on women, including its effects on pregnancy and lactation. This paper will examine certain cases of faulty breast implants and also the relation between breast implantation and certain diseases.

1.6 Significance of the Study

This study is expected to be of great significance to both the researcher and to others. Firstly, the study will allow the researcher to have great insight on the issue of breast implant in the United Kingdom and other parts of the world covered in this paper. Furthermore, this paper will be of great importance to other researchers who are and will be interested in carrying out further research in breast implants in any part of the world, as this paper will provide great information needed for the successful completion of such research. Thirdly, this research will be of great importance to women seeking for breast implants, as they stand a chance to know the benefits and complications that might result from the procedure. Finally, this research will be of great importance for women who had received faulty breast implant so that they can know the complications that may result from such implants.

1.7 Research Questions

This paper will aim to answer the research questions outlined below.

- What are the benefits of PIP breast implants?
- What are the complications that may arise from PIP breast implants?
- What relations exist between breast implant and certain diseases?
- What went wrong in the recent issues of faulty breast implants in UK women and other women around the world?
- Mechanism that exist to regulate the use of Medical Implants and Devices

1.8 Organization of Chapters

This paper would be grouped into four sections or chapters, apart from this introduction chapter. The second section of this research paper will be the review of relevant literatures related to the problem or issue of faulty breast implants and diseases related to such implants on the long run. The chapter three would critically analyze the faulty breast implants and cover some articles that provide information on the issues of PIP implants and recent discoveries of faulty breast implants in the United Kingdom. Finally, the chapter four of this analytic paper would be the concluding chapter that would summarize all the findings in other chapters.