FDA Implant Consumer Handbook - 2004

 The U.S. Food & Drug Administration has published a handbook for the guidance of women who are considering breast augmentation surgery.

The section headed "Local Complications and Re-operations" is quoted below for your information and guidance:

Quote:

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 implant safety in June 1999.⁶ 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 implant, 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 undergoing breast augmentation, reconstruction, or revision:

• Breast implants will not last a lifetime. Either because of rupture or other complications, you will likely need to have the implants removed.

• You are likely to need additional doctor visits and reoperations because of one or more complications over the course of your life.

• You are likely to have the implants removed, with or without replacement, because of one or more complications over the course of your life.

• Many of the changes to your breast following implantation may be cosmetically undesirable, as well as irreversible (cannot be undone).

• If you later choose to have your implants removed, you may experience unacceptable dimpling, puckering, wrinkling, loss of breast tissue, or other undesirable cosmetic changes of the breast.

Potential local breast implant complications are bulleted below. You may need non-surgical treatments or reoperations (including removal of your implant) to treat any of these local complications. Potential local complications include, but are not limited to:

Refer to the Glossary at the front of this handbook for a brief definition of each of the complications bulleted above. If you need more explanation, you should ask your doctor before you make your decision whether or not to get breast implants.

Below is a more detailed discussion of reoperation, removal, and the four bolded local complications bulleted above.

Reoperation

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.

Reasons for reoperations could include any of the potential local complications bulleted above, such as capsular contracture, wrinkling, asymmetry, rupture/deflation, implant malposition, etc.

The type of surgical procedure(s) performed during the reoperation depends on the local complication involved. More than one procedure may be performed in a single reoperation. Examples of the types of surgical procedures that may be performed in a reoperation include:

• implant removal with or without replacement

• capsule procedure (e.g., removal or surgical release of the capsule)

• scar or wound revision (e.g., surgical removal of excess scar tissue)

• drainage of a hematoma (e.g., inserting a needle or tube through the skin to drain the collection of blood)

• repositioning of the implant (e.g., surgically opening the incision and moving the implant)

• biopsy/cyst removal (e.g., inserting a needle through the skin or cutting through the skin to remove a lump).

Multiple reoperations to either improve the appearance of the breasts, to remove ruptured/deflated 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 implants were studied together).  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.

Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed reoperation rates of 13-21% at 3 years and 20-26% at 5 years for augmentation patients. The same studies showed reoperation rates of 39-40% at 3 years and 43-45% at 5 years for reconstruction patients.

Removal

Removal of the implant(s), with or without replacement, is one type of surgical procedure that may be performed in a reoperation. As stated above, you are likely to have your implant removed at some time over the course of your life because of one or more local complications.

Reasons for removal could include any of the potential local complications bulleted above, such as capsular contracture, wrinkling, asymmetry, unsatisfactory size/style, etc. Many women decide to have the implants replaced, but some women do not. Women who do not have their implants replaced may have cosmetically undesirable dimpling, puckering, or sagging of the breast following removal of the implant, or both. Recall that some health insurance companies may not cover implant removal or implant replacement even though the first implant surgery was covered by health insurance.

Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed implant removal rates of 8% at 3 years and 12-14% at 5 years for augmentation patients. The same studies showed implant removal rates of 23-27% at 3 years and 28-30% at 5 years for reconstruction patients.

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 implant(s) were removed or replaced. The average time to removal, as reported by those who remembered the date of their surgery, was 11.5 years.

Photograph 1 below shows the same 29-year-old woman in Photograph 3 (see the Capsular Contracture subsection below) one year after removal of her silicone gel-filled breast implants without replacement. Women with large implants, particularly those inserted subglandularly (under and within the breast glands but on top of the chest muscles), may have a major cosmetic deformity if they choose not to replace them or to undergo additional reconstructive surgery.

Photograph 1: Implant removal without replacement in augmentation patient.

Rupture/Deflation

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. Others may take 10 or more years to rupture/deflate.

The following surgical practices are contraindicated (not recommended) for the approved saline-filled breast implants because they are known to cause rupture/deflation:

• closed capsulotomy (technique used to relieve capsular contracture involving manually squeezing the breast to break the hard capsule)

• placement of drugs/substances inside the implant other than sterile saline

• any contact of the implant with Betadine® ¹⁵

• injection through the implant shell

• alteration of the implant

• stacking of the implants (more than one implant per breast pocket).

In addition to the surgical practices above that have been shown to cause rupture/deflation of saline-filled breast implants, there are other reasons for rupture/deflation of breast implants. Companies are currently studying what these other reasons are.

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

• normal aging of the implant

• damage by surgical instruments

• too much handling during surgery

• damage by procedures to the breast, such as biopsies and fluid drainage

• compression during mammographic imaging

• stresses such as trauma or intense physical pressure

• capsular contracture

• overfilling or underfilling of saline-filled breast implants

• placement through an umbilical (belly button) incision site because it involves too much handling of the implant.

Doctors usually recommend removal of the implant if it has ruptured, regardless of whether it is saline-filled or silicone gel-filled.

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. Implant deflation usually happens 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 implant.

The IOM report¹⁶ stated that the deflation rate reported in the medical literature across studies was 7% at 7 years. The IOM report also stated that earlier saline-filled breast implant models had more frequent deflations than modern models. The IOM estimated that 1-3% of modern saline-filled breast implants would have ruptured by the first year and that this rate would increase over time. The modern models show a 5-10% rupture rate after 10 years, according to one study.

Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients. The same studies showed rupture/deflation rates of 6-9% at 3 years and 8-18% at 5 years for reconstruction patients.

Photograph 2 below shows a 30-year-old woman's left saline-filled breast implant deflation. The suspected cause was the leaf-valve design of the implant, which is generally not used these days.

Photograph 2: Deflation in augmentation patient.

Rupture/Deflation of Silicone Gel-Filled Breast Implants -

Because silicone gel is thicker than saline, when a silicone gel-filled breast implant ruptures, the gel may remain contained within the fibrous capsule. This is called an intracapsular rupture. An intracapsular rupture 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 with a silent rupture, a magnetic resonance imaging (MRI) examination is needed to determine whether or not a silent rupture has happened. MRI with equipment specifically designed for imaging the breast is currently the most sensitive method for detecting rupture of a silicone gel-filled breast implant in women with silent ruptures.

With some silicone gel-filled implants ruptures, women may notice a decreased breast size, a change in breast implant shape, hard lumps over the implant or chest area, an uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. Ruptures of this type are called symptomatic (show symptoms) and are usually extracapsular (gel outside the fibrous capsule). However, some extracapsular ruptures can be silent (show no symptoms).

Silicone gel that escapes the scar capsule surrounding the implant may migrate away from the breast. The free silicone gel may cause lumps called granulomas to form in the breast or in other tissues where the silicone gel has migrated, such as the breast tissue, chest wall, armpit, or arm. Silicone gel may also migrate to distant organs such as the liver. Migrated silicone gel may be difficult or impossible to remove.

The IOM report²⁰ stated that rupture rates reported in the medical literature across studies ranged from 0.3-77%. This large range of rupture rates is due to the different types and models of implant, varying durations of implantation, different types of groups of women studied, and other factors. The IOM report also stated that extracapsular gel (gel outside the fibrous capsule) was present in about 12-26% of gel-filled ruptures reported in the medical literature. The IOM estimated that less than 10% of modern silicone gel-filled breast implants would have ruptured by five years and that rupture rate would continue to increase over time.

FDA reported a retrospective study on rupture of silicone gel-filled breast implants. This study included augmentation women who had breast implants before 1988. There were 344 women (with 687 implants) who had a MRI examination of their breasts to determine whether or not there was evidence of rupture of their implants. Of the 687 implants in the study, 378 implants (55%) were ruptured. This means that 69% of the 344 women had at least one ruptured breast implant. Of the 265 women with at least one rupture, 73 (21%) had extracapsular (outside the capsule) silicone gel in one or both breasts. Factors that were associated with rupture included the age of the implant, the specific manufacturer of the implant, and the surgical placement (submuscular versus subglandular) of the implant.

According to the IOM report , the diagnosis of rupture of a gel-filled breast implant is important because the release of silicone gel and fluid into the tissues may result in local complications. An intracapsular rupture may become extracapsular, and both are generally agreed to indicate the need for removal of the implant. The rupture rate over time (both intracapsular and extracapsular) of modern silicone gel-filled breast implants is currently not well characterized. The silent rupture rate over time is not known for modern silicone gel-filled breast implants.

Capsular Contracture

Capsular contracture happens when the scar tissue or capsule that normally forms around the implant tightens and squeezes the implant. It can happen to one or both of the implanted breasts.

There are four grades of capsular contracture - Baker grades I through IV. The Baker grading is as follows:

Capsular contracture may be more common following infection, hematoma, and seroma. However, it is not known for sure why capsular contracture happens. The literature also discusses other factors, such as a textured implant surface and submuscular placement of the implant, which may decrease the capsular contracture rate.

A reoperation may be needed to correct capsular contracture, usually for grade III or IV capsular contracture. The surgical procedures range from removal of the implant capsule tissue with or without replacement of the implant itself. Capsular contracture may happen again after this reoperation.

The IOM report stated that, for studies involving both silicone gel-filled and saline-filled breast implants, the capsular contracture rates were 36-81% for silicone-gel filled breast implants and 8-41% for saline-filled breast implants.

Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rates of grade III or IV capsular contracture of 9% at 3 years and 10-11% at 5 years for augmentation patients. The same studies showed rates of grade III or IV capsular contracture of 25-30% at 3 years and 29-36% at 5 years for reconstruction patients.

Photograph 3 below shows grade IV capsular contracture in the right breast of a 29-year-old woman seven years after subglandular placement of 560cc silicone gel-filled breast implants.

Photograph 3: Capsular contracture in augmentation patient.

Breast Pain

Women may feel pain of varying degrees and length of time following breast implant surgery. In addition, improper size, placement, surgical technique, or capsular contracture may result in pain. You should tell your doctor if you have pain.

The IOM report stated that pain is one of the primary reasons for implant removal and replacement even though few studies included in the medical literature report information about pain.

Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed breast pain rates of 5-16% at 3 years and 7-17% at 5 years for augmentation patients. The same studies showed breast pain rates of 15-17% at 3 years and 16-18% at 5 years for reconstruction patients.^31,32

Nipple and Breast Sensation Changes

Sensation (feeling) in the nipple and breast can increase or decrease after implant surgery. The range of changes varies from intense sensation to no sensation in the nipple or breast following surgery. Changes in sensation can be temporary or permanent and may affect sexual response or the ability to nurse a baby. (Refer to the Specific Issues to Consider section for more information on breast feeding.)

Prospective studies^33,34 of saline-filled breast implants approved by FDA in May 2000 showed the following changes with regard to nipple and breast sensation for augmentation:

• intense nipple sensation in 5-9% of women at 3 years and in 10% of women at 5 years

• loss of nipple sensation in 8-10% of women at 3 years and in 10% of women at 5 years

• intense skin sensation in 7% of women at 3 years and in 8% of women at 5 years.

The same prospective studies of saline-filled breast implants approved by FDA in May 2000 showed the following changes with regard to nipple and breast sensation for reconstruction:

• loss of nipple sensation in 12-35% of women at 3 years and in 18% of women at 5 years

• intense skin sensation in 6% of women at 3 years and in 6% of women at 5 years.

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Source:

US FDA/CDRH: FDA Breast Implant Consumer Handbook - 2004 - Local Complications &  Reoperations