Breast Implants - Everything You Wanted to Know

The three basic types of breast implants are saline-filled breast implants, silicone gel-filled breast implants, and alternative breast implants (e.g., soybean oil) implants. Breast implants are designed for treatment of augmentation, reconstruction, and revision patients. While many women believe breast implants cause illnesses, such as autoimmune disease, this is not proven at this time. However, most women with breast implants will experience local complications, such as pain, capsular contracture, and rupture/deflation of the breast implants. You may need to have nonsurgical treatments or reoperations to treat local complications for your breast implants. Breast implants do NOT last a lifetime. You should be prepared for long-term follow-up, reoperations to treat complications, and personal financial costs with breast implants.

Personal Financial Costs
Surgery for breast implants and treatment of complications may not be covered by your health insurance.

Before getting breast implants, be sure to get, in writing, answers from your insurance company to the following questions, at a minimum:

• Does my policy cover the costs of the implant surgery, the breast implants, the anesthesia, and other related hospital costs?
• Does it cover removal and replacement of the breast implants if this becomes necessary? To what extent?
  
• Does it cover the cost of detecting or treating a complication as a result of either the breast implants or the reconstruction? To what extent?
  
• Will there be an increase in my insurance premium? To what extent?
  
• Will future coverage be affected? To what extent?

In addition to collecting information from your insurance company, you should also ask your doctor to provide cost information such as:

• What are the costs of getting breast implants (the breast implants, the anesthesia, the surgery, etc.)?
  
• What are the costs for follow-up visits after my breast implants?
  
• What are the costs for detecting or treating a complication, especially treatment that involves a reoperation, such as breast implants removal with or without replacement?
  
• What is the specific manufacturer warranty for the breast implants that you are gathering information on?

Realistic Expectations With Breast Implants
Your decision whether or not to get breast implants should be also based on realistic expectations of the outcome. There is no guarantee that your results will match those of other women. Your results with breast implants will depend on many individual factors, such as your overall health, chest structure, breast/nipple shape and position, skin texture, healing capabilities, tendency to bleed, prior breast surgery, surgical team’s skill and experience, type of surgical procedure, and type and size of your breast implants.

Breast implants may vary in shell surface, shape, profile, volume, and shell thickness. The primary parts of most breast implants are a shell, a filler, and a patch to cover the manufacturing hole.

With respect to the shell design, while most breast implants are single lumen, some breast implants are double lumen. With respect to the filler, some breast implants are manufactured with a fixed volume of filler, some are filled during the operation, and some allow for adjustments of the filler volume after the operation.

It should be noted that tissue expanders, which are silicone shells filled with saline, are regulated by FDA in a different way than breast implants. This is because tissue expanders are intended for general tissue expansion for a maximum of 6 months, after which, they are to be removed. Because of this, the design specifications and preclinical testing recommendations are different for tissue expanders than for breast implants. Tissue expanders are not to be confused with the third type of double lumen silicone gel-filled breast implants described in the Silicone Gel-Filled breast implants section below.

STATUS / AVAILABILITY OF BREAST IMPLANTS

Saline-Filled Breast Implants
Prior to August 1999, saline-filled breast implants were sold on the market either as preamendments devices or as 510(k)-cleared devices. In August 1999, FDA issued a regulation that required that all saline-filled breast implants be PMA-approved to be sold on the market. However, those companies that had a preamendments or 510(k)-cleared saline-filled breast implants and submitted their PMA within 90 days of the August 1999 regulation were allowed to keep their device on the market until the final decision/actions were made in May 2000. Since May 2000, saline-filled breast implants must be PMA-approved to be sold on the market.

Silicone Gel-Filled Breast Implants
Prior to 1991, silicone gel-filled breast implants were sold on the market as either preamendments devices or as 510(k)-cleared devices. In April 1991, FDA issued a regulation that required that all silicone gel-filled breast implants be PMA-approved to be sold on the market.

Alternative Breast Implants
All alternative breast implants are reviewed through the PMA process because they are post-amendments devices. As of the date of this article, there are no alternative breast implants approved for marketing. Therefore, all alternative breast implants are considered investigational devices. To receive an alternative breast implant in the US, you must enroll in an IDE study.

LOCAL COMPLICATIONS & REOPERATIONS WITH BREAST IMPLANTS

The Institute of Medicine (IOM) completed its independent review of past and ongoing scientific research of silicone [both saline-filled and silicone-gel filled] breast implants safety in June 1999. Below are some of the major findings from the IOM report.

• Local complications are the primary safety issue with breast implants because they are frequent enough to be a concern.
  
• Local complications accumulate over the lifetime of the breast implants, and they have not been well studied.
  
• Information on local complications is crucial for women deciding whether or not they want breast implants.

Key points to consider whether you are getting breast implants, reconstruction, or revision:

• Breast implants will not last a lifetime. Either because of rupture or other complications, you will likely need to have the breast implants removed.
  
• You are likely to have the breast implants removed, with or without replacement, because of complications.
  
• If you later choose to have your breast implants removed, you may experience unacceptable & undesirable cosmetic changes of the breast.

Reoperation for Breast Implants
As stated above, it is likely that you will need to have one or more reoperations over the course of your life because of local complications from breast implants.

Multiple reoperations to either improve the appearance of the breasts, to remove ruptured/deflated breast implants, or both may result in an unsatisfactory cosmetic outcome.

A retrospective study by Gabriel, et al. showed that 24% of women with breast implants had complications resulting in a reoperation during the first five years after implantation (silicone and saline breast implants were studied together). 7 According to this study, about 1 in 3 women getting breast implants for reconstruction needed a reoperation within five years, and about 1 in 8 women getting breast implants for augmentation needed a reoperation within five years.

Removal of Breast Implants
Removal of breast implants, with or without replacement, is one type of surgical procedure that may be performed in a reoperation.

Reasons for the removal of breast implants could include any of the potential local complications, such as capsular contracture, wrinkling, asymmetry, unsatisfactory size/style, etc. Many women with breast implants decide to have the breast implants replaced, but some women do not. Women who do not have their breast implants replaced may have cosmetically undesirable dimpling, puckering, or sagging of the breast following removal of the breast implants, or both.

In a retrospective study of augmentation patients with silicone gel-filled breast implants, 303 of 907 (33%) of women reported that they had at least one reoperation in which their breast implants were removed or replaced. The average time to removal, as reported by those who remembered the date of their surgery, was 11.5 years.

Rupture/Deflation with Breast Implants
breast implants do not last a lifetime. Some breast implants rupture/deflate 14 in the first few months after being implanted and some deflate after several years. Other breast implants may take 10 or more years to rupture/deflate.

Some possible reasons for rupture/deflation of breast implants include:

• normal aging of the breast implants
  
• damage to the breast implants by surgical instruments
  
• too much handling of the breast implants during surgery
  
• damage by procedures to the breast, such as biopsies and fluid drainage
  
• compression of the breast implants during mammographic imaging
  
• stresses to the breast implants such as trauma or intense physical pressure
  
• capsular contracture of the breast implants
  
• overfilling or underfilling of saline-filled breast implants
  
• placement for the through an umbilical incision site because it involves too much handling of the breast implants.

Rupture/Deflation of Saline-Filled Breast Implants
Saline-filled breast implants rupture/deflate when the saline solution leaks either through an unsealed or damaged valve or through a break in the implant shell. Deflation of breast implants usually happen immediately but sometimes it happens slower over a period of days. Deflation of saline-filled breast implants is noticed by a loss of size or shape of the breast implants.

Rupture/Deflation of Silicone Gel-Filled Breast Implants
Because silicone gel breast implants are thicker than saline, when silicone gel-filled breast implants ruptures, the gel may remain contained within the fibrous capsule. This is called an intracapsular rupture and is usually a silent rupture, which means that it happens without a visible change or feel by the woman and is not evident by a physical examination by the doctor. Because the woman and her doctor will not see or feel any changes of their breast implants with a silent rupture, a magnetic resonance imaging (MRI) examination is needed to determine whether or not a silent rupture of the breast implants has happened. MRI with equipment specifically designed for imaging the breast is currently the most sensitive method for detecting rupture of silicone gel-filled breast implants in women with silent ruptures.

Breast Pain With Breast Implants
Women may feel pain of varying degrees and length of time following breast implants. You should tell your doctor if you have pain with your breast implants.

Nipple and Breast Sensation Changes With Breast Implants
Sensation in the nipple and breast can increase or decrease after breast implants. The range of changes varies from intense sensation to no sensation in the nipple or breast following breast implants surgery.

BREAST IMPLANT SURGERY & RELATED ISSUES

Choosing an Implant
You should consider the following when you and your surgeon are discussing breast implants.

Shape and Size of Breast Implants
Depending on the desired shape and size you wish to achieve with your breast implants, you and your surgeon may choose a round or contoured implant shape of appropriate size. You should be aware that contoured breast implants that are placed submuscular may assume a round shape after implantation. Your surgeon will also evaluate your existing tissue to determine if you have enough to cover the breast implants.

Implant Surface
Textured surface breast implants were designed to reduce the chance of capsular contracture. Some studies of a large number of women with saline-filled breast implants show no difference in the likelihood of developing capsular contracture with textured breast implants when compared to smooth-surfaced breast implants.

Implant Palpability/Visibility for Breast Implants
The following may cause breast implants to be more palpable or more visible: textured breast implants; larger breast implants; subglandular placement; and smaller amount of skin/tissue available to cover the implant.

Choosing the Surgical Incision Site For Breast Implants
You should discuss the pros and cons for each incision site for your breast implants you are considering with your surgeon.

AUGMENTATION INCISION SITES
The three common incision sites for breast implants are under the arm, around the nipple, or within the breast fold.

Transaxillary Incision for Breast Implants
This incision for breast implants is less concealed than periareolar but associated with less difficulty than the periareolar incision site when breast feeding.

Periareolar Incision for Breast Implants
This incision for breast implants is most concealed but is associated with a higher likelihood of inability to successfully breast feed, as compared to the other incision sites.

Inframammary Incision for Breast Implants
This incision for breast implants is less concealed than periareolar but associated with less difficulty with breast feeding than the periareolar incision site.

Reconstruction Incision Sites For Breast Implants
Most breast implants in breast reconstruction use the mastectomy scar either immediately during the mastectomy procedure or after tissue expansion.

Choosing the Type of Implant Placement
breast implants can be placed either submuscularly or subglandularly.

Submuscular Placement Possible Results

• Surgery may be longer for breast implants
• Recovery may be longer for breast implants
• Reoperation may be more difficult
• Less palpable breast implants
• Easier imaging during mammography exam

Subglandular Placement Possible Results

• Surgery may be shorter for breast implants
• Recovery may be shorter for breast implants
• May provide easier access for reoperation
• More palpable breast implants
• More difficult imaging during mammography exam

These photos show the differences between subglandular and submuscular placement of your breast implants compared to a breast before augmentation.

Questions to Ask Your Surgeon about Breast Implants
The following list of questions may help you to remind you of topics to discuss with your surgeon about breast implants. You may have additional questions as well.

• What are the risks and complications associated with having breast implants?
  
• How many additional operations of my breast implants can I expect over my lifetime?
  
• How will my breasts look if I choose to have the breast implants removed without replacement?
  
• What shape, size, surface texturing, incision site, and placement site for the breast implants is recommended for me?
  
• How will my ability to breast feed be affected by my breast implants?
  
• How can I expect my breast implants to look over time?
  
• How can I expect my breast implants to look after pregnancy? After breastfeeding?
  
• What are my options if I am dissatisfied with my breast implants?
  
• What alternate procedures are available if I choose not to have breast implants?
  
• Do you have before and after photos of breast implants?