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). 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.
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.
Source: The U.S. Food and Drug Administration (FDA)
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:
. Asymmetry
. Inflammation/irritation
. Breast pain
. Malposition/displacement
. Breast tissue atrophy
. Necrosis
. Calcification/calcium deposits
. Nipple/breast sensation changes
. Capsular contracture
. Palpability/visibility
. Chest wall deformity
. Ptosis
. Delayed wound healing
. Redness/bruising
. Extrusion
. Rupture/deflation
. Galactorrhea
. Scarring
. Granuloma
. Seroma
. Hematoma
. Unsatisfactory style/size
. Iatrogenic injury/damage
. Wrinkling/rippling
. Infection, including Toxic Shock Syndrome
Source: FDA Breast Implant Consumer Handbook – 2004
- 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.
Source: FDA Breast Implant Consumer Handbook
Some of the risks of breast implants include:
- reoperations (additional surgeries), with or without removal of the device
- capsular contracture (hardening of the area around the implant)
- breast pain
- changes in nipple and breast sensation
- rupture with deflation for saline-filled implants
- rupture with or without symptoms for silicone gel-filled implants
- migration of silicone gel for silicone gel-filled breast implants.
Source: Center for Devices and Radiological Health
Information about participation in a clinical study can be obtained from the companies conducting the study. See the company contact information at http://www.fda.gov/cdrh/breastimplants/addsources.html.
Source: U.S. Deparment of Health and Human Services
There are several ongoing clinical studies (i.e., investigational device exemption (IDE) applications) of saline and silicone gel-filled breast implants. These studies include those for the more cohesive silicone gel-filled breast implants manufactured by Mentor and Allergan (formerly Inamed), as well as studies conducted by other manufacturers. These devices are still in research and have not been approved for marketing.
In addition, Mentor and Allergan will are conduct studies on patients who get silicone gel-filled breast implants after they are approved.
Source: U.S. Department of Health and Human Services
FDA approved saline-filled breast implants for augmentation in women ages 18 and older. FDA approved silicone gel-filled implants for women ages 22 and older. The age restrictions are different because the risks are different for the two products. For example, silicone gel-filled implants will require frequent MRI monitoring to detect silent rupture (a rupture that can go undetected by you or your doctor). There is no risk of silent rupture for saline-filled implants. In addition, the health consequences of a ruptured saline-filled breast implant are different from those of a ruptured silicone gel-filled breast implant.
Source: U.S. Department of Health and Human Services
Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 18 years or older.
Mentor and Allergan silicone gel-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 22 years or older.
FDA restricts the marketing of breast implants for augmentation to women of a minium age because young women’s breasts continue to develop through their late teens and early 20s and because there is a concern that young women may not be mature enough to make an informed decision about the potential risks. However, there is there is no age restriction on the marketing of these products for reconstruction, so as to allow young women to have access to breast implants to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality.
As for devices that are not approved for marketing, there are various age criteria and other restrictions for women who receive breast implants as part of a clinical study. Contact one of the companies conducting a study for more information. See the company contact information at http://www.fda.gov/cdrh/breastimplants/addsources.html.
Source: U.S Department of Health and Human Services
Breast implants are used for:
- primary augmentation (to increase breast size for cosmetic reasons)
- revision-augmentation ( revision surgery to correct or improve the result of an original breast augmentation surgery)
- primary reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality)
- revision-reconstruction ( revision surgery to correct or improve the result of an original breast reconstruction surgery).
Source: Center for Devices and Radiological Health
FDA has approved four breast implants for marketing in the U.S.:
- In May 2000, Mentor and Allergan (formerly Inamed) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.
- In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.
All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive (“gummy bear”) implants. For a woman to receive an investigational breast implant in the U.S., she must enroll in a clinical study.
Source: Center for Devices and Radiological Health
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