Breast Implant Surgery Gone Wrong, and Complications
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:
. 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
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.
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). 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.8,9
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.10,11
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.12 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.13 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.