12 November 2020
Development of Breast Implants
Breast Implants, since their initial development in 1961 by Cronin and Gerow with the help of Dow Corning, have made a great impact on the lives of many women both through breast augmentation for volume increase and reconstruction for rehabilitation of women after mastectomy for cancer.
Since the initial use in a patient for augmentation in 1962, there have been gradual improvements in the style and quality of the implants.
The initial implants were made of a silicon-rubber envelope filled with viscous silicone gel.
In the 1970s, a number of improvements were made.
Initially, a thinner gauge of implant shell and filler gel of low cohesion were developed to give a more realistic shape, size and consistency. However, there were problems with fragility, rupture, bleed and capsular contracture that occurred.
A further improvement was made by the use of a polyurethane foam coating of the shell, which appeared to reduce capsular contracture. There were some concerns about the risk from TDA. (2,4 – Toluenediamine), a carcinogenic byproduct of the chemical breakdown of the polyurethane foam but eventually this was considered too small a risk to be of any concern.
Further improvement was a double lumen implant, in which an inner silicone gel implant was contained in an outer saline implant. However, due to the high device failure rate, the double lumen implant did not gain much popularity.
Generation 3 and 4
Further improvements were made with elastomer coated shells to reduced bleed, thicker increased cohesion filler gels and shaped anatomical models with textured surfaces to avoid implant rotation.
Since the mid-1990s, implant shells have been made of semi-solid gel to reduce bleed and migration of gel.
Summary of Developmental Changes
The outer shells have become stronger and the silicone gel used for the filling has become more cohesive.
The implants are available in round and anatomical shapes, with the former being available in round or textured surfaces while the latter is available only with textured surfaces to overcome the risk of implant rotation.
There is also a greater availability of shapes and projections, to customize the choice of implant to suit the patient best.
Problems and Complications With The Use of Breast Implants
The majority of patients have good outcomes with the use of breast implants.
Some patients have relatively minor problems, which are well tolerated and needing no further treatment. However, in a small proportion of patients, the problems can become more troublesome and needing further treatment. The major issue is often the problem of capsular contracture.
Silicone, despite being a foreign matter, appears to be very well tolerated by the body, probably due to the material being a relatively inert one. However, a very rapid response from the body to an implant is the development of a tissue capsule around the implant to separate it from the breast cavity. These tissue capsules are capable of contracting around the implant.
Capsular contractures are graded according to the Baker – Gordon Classification:
Grade 1 – the breast looks and feels normal
Grade 2 – the breast looks normal but feels slightly firm
Grade 3 – the breast looks abnormal and feels firm
Grade 4 – the breast looks abnormal, is painful and interferes with the activities of daily living. Fortunately, approximately 80% of patients with implants fall into grade 1 – 3 and require no further treatment.
Of the 20% with grade 4 capsular contractures, about half can be converted to grade 3 with increasing the size of the breast cavity and reducing the size of the implant.
The remaining patients in whom there is the persistence of grade 4, have little choice but to have the implant removed permanently as the body reaction suggests that there is a strong reaction provoked by the silicone implant and persisting with this stimulus might lead to an autoimmune problem.
Breast Implant Illness (BII)
While capsular contractures and gel leak, bleed and implant rupture are well recognized complications, there is increasing evidence, mainly anecdotal, that a proportion of patients with breast implants exhibit troublesome medical symptoms which are difficult to explain but have gained significant relief with the removal of these implants.
For a long time, these symptoms, while present in a proportion of patients with implants, have not been recognized by many in the industry and profession. There has been a change recently and in May 2019, the FDA released a statement it was taking steps to better characterize “Breast Implant Illness (BIA)” and its risk factors, and for implant recipients to have all of this information available to them.
While information was being gathered on BII, a new problem appeared when it was noted that some women were presenting with swollen, tender and enlarged breasts on one side, presence of a lump in the breast or armpit, usually about 5 – 7 years after breast augmentation. Further investigation showed the presence of a fluid collection around the implant.
Examination of the lump in the breast or armpit or of the fluid collection in a small proportion of patients showed the presence of Anaplastic Large Cell Lymphoma, which has now been named Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL).
First seen in 1997, over the last 5 – 7 years, there have been about 900 patients who have been diagnosed with BIA-ALCL. A feature common to all patients is that they received textured implants. Treatment will involve PET/CT scans to check if there is spread elsewhere in the body.
After evaluation by an Oncologist for staging of the disease and treatment planning, the implant along with the capsule is removed.
Patients with advanced disease may require treatment with chemotherapy or in rare cases radiation therapy.
Changes To The Practice Of Use Of Breast Implants
There has been a worldwide recall / cessation of sale of textured breast implants.
Many surgeons, including myself, now restrict ourselves to the use of round, smooth implants.
More work is being done to develop tests to check potential allergy and reaction to silicone amongst patients needing breast implants.
In addition, greater investigation needs to be done to see if there are allergic or autoimmune patterns in a patient’s history.
In addition, patients need to be fully updated on the above problems noted with the use of breast implants, to help them make informed decisions about going down this path.
1 – Special Report: Breast Implant Illness and BIA-ALCL. www.breastcancer.org (16.9.2020)
2 – What is BIA-ALCL? www.breastcancer.org (16.09.2020)
3 – What is Breast Implant Illness? www.breastcancer.org (16.09.2020)
4 – Frequently Asked Questions About Breast Implant Illness and BIA-ALCL www.breastcancer.org (16.09.2020)
5 – Breast Implant Patient Informed Consent Checklist and Black Box Warnings – Developed by the Breast Implant Working Group