Silicone gel breast implants were first marketed in the United States in 1962. The FDA began regulating these medical devices in 1976. In 1992, however, the FDA restricted the use of silicone gel breast implants, except for patients requiring revision or mastectomy surgery. At that time, saline implants became the primary prosthesis for breast augmentation, replacing silicone implants until 2006.
When a silicone breast implant ruptures, it usually does not deflate, and it may go unnoticed. The filler gel leaks slowly out of the implant over time, spreading through the implant pocket. It begins intracapsular, becomes extracapsular, and then migrates throughout the chest and lymphatic tissue throughout the body. Implants can rupture as a result of:
- Damage during the original implantation or other surgery
- Blunt trauma
- Penetrating or blast injury to the chest
- Chemical degradation of the implant shell
- Mechanical pressure on the breast, including mammograms and ultrasounds
Rupture Rates for Silicone Breast Implants
The incidence of silicone breast implant rupture has been found to be approximately 15% between the third and 10th year after implantation. Findings showed an overall rupture rate of around 5.3 ruptures per 100 implants per year. The regularity of implant failure has been shown to increase with time. The double lumen implants were associated with lower risk than single lumen implants. For the most moderate implants, there is an estimate of rupture-free survival of 98% in five years, 83-85% at 10 years. Because a breast implant is considered a Class III medical device with a limited product life, the rupture rate factors are associated with its age and design. A breast implant device can retain its mechanical integrity for several decades in a woman’s body. We know that when saline implants rupture, it leaks and it empties quickly and it can be readily removed and replaced with a saline implant.
In Allergan’s core study, implant failure was assessed in patients who had MRI screening for silent ruptures, as well as those who were not evaluated for rupture by an MRI. The rupture rate in the MRI patients was found to be 8.6% for primary augmentation and 11.4% for primary reconstruction. The rupture rate for the total cohort in the core study including breast augmentation, reconstruction, revision augmentation and revision reconstruction through seven years was 7.35 per patient. Across all patients in the core study, all ruptures were intracapsular with a single case of extracapsular gel following exploratory surgery to confirm the implant failure and replace the device. The average age of implants was roughly 11 years. Silent rupture was found in approximately 15% of the combined group and 8% of revision patients. Studies of Danish women who were observed over a two-year period using MRI revealed that 10% of the implants with intracapsular rupture progressed to extracapsular rupture by MRI. About three-fourths of the implant ruptures remained intracapsular, with the remaining 25% extracapsular.
In the core study provided by MENTOR®, the rupture assessed for patients who had MRI’s to screen for silent ruptures were evaluated. All reported ruptures were from patients in the MRI cohort. The rates were .5% for primary augmentation and 7.7% for revision augmentation.
Symptoms of Ruptured Silicone Breast Implants
Some patients may be asymptomatic, and accurate results may be found using diagnostic radiograph, including MRI. Patients often will develop silicone mastitis and calcified granulomas due to ruptured silicone breast implant material once it becomes extracapsular. An MRI can determine whether the rupture is intracapsular or extracapsular. It is recommended for patients to consult with their board-certified plastic and reconstructive surgeon for evaluation as well as diagnostic MRI testing to determine the integrity of their implants. Patients may have a ruptured silicone breast implant if they experience the following symptoms:
- Hardened breasts or capsular contracture
- Loss of upper pole fullness of one breast
Some breast implant complications are associated with capsular contracture, changes in breast shape and size, and breast pain. Possible complications of silicone breast implant rupture include lymphatic spread to the axillary lymph nodes and all lymphatic tissue throughout the body. While there are concerns about the link between silicone breast implants and certain illnesses, there is no scientific evidence that links silicone breast implant rupture to severe diseases, such as breast cancer, rheumatic disease, autoimmune disease, or connective tissue disorders.
There are rare reports of gel migration to surrounding tissue, such as the chest wall, armpit, or abdominal wall as well as down the arm or to the groin area. This can lead to nerve damage, granuloma formation, and breakdown of tissue. There have also been a few incidents of silicone presence in the liver of patients with silicone breast implants. Additionally, silicone gel material can migrate to the lymph nodes in the axilla, even in women without evidence of rupture, leading to lymphadenopathy.
Capsular contracture is substantially increased in patients with ruptured silicone implants. It is one of the most common reasons for reoperation. The risk of developing capsular contracture rises over time, and it may be also be triggered by infection, hematoma, seroma, and implant failure. Stages of capsular contracture include:
- Baker I: soft breast, no evidence
- Baker II: palpable hardness to the breast
- Baker III: palpable and visible distortion
- Baker IV: hard, palpable, visible and painful to the touch.
An open capsulectomy (removal of scar tissue) or capsulotomy (releasing of the scar tissue around the implant) may be performed to correct capsular contracture. Patients with ruptured silicone breast implants and capsular contracture will often experience varying degrees of pain that may persist following the corrective surgery.
Changes in Sensation
Implant rupture may cause changes in nipple sensation. Patients with ruptured implants can experience either an increase or decrease in sensitivity, but radiation therapy can also greatly reduce sensitivity to the breast and chest wall. A proper diagnosis can determine whether these changes have resulted from implant rupture or other complications.
Infection may develop when an implant ruptures. The signs of acute infection can include redness, swelling, tenderness, fluid collection, pain, and fever. Toxic shock syndrome, which can be fatal, may also occur in some cases. It is often associated with high temperatures over 102 degrees, nausea, vomiting, rash, lightheadedness, dizziness, and hypotension. Patients go to the emergency room for treatment immediately if they experience any symptoms of toxic shock syndrome.
Diagnosis of Implant Rupture
Studies show that the risk of implant rupture increases over time and that silicone gel breast implants are not lifetime devices. The imaging tests that can be used to determine a ruptured silicone gel breast implant include mammogram, CT scan, ultrasound, and MRI. A pathologist should rule out any possibility of breast cancer.
Patients are advised to undergo annual mammograms after the age of 35. When a mammogram has diagnosed an implant rupture, a patient may not require further imaging studies before surgical intervention. However, mammography has been known to produce false/negative readings, so a patient who receives a negative result may actually have a ruptured silicone implant. Due to the limitations of mammogram and ultrasound, in November 2006, the FDA recommended that patients have an MRI performed every three years to assess their implants for abnormalities. CT scans are not ideal because they involve ionized radiation and have not been studied to the extent that the MRI’s have.
When an implant has been found to be ruptured, I believe the implant and implant material should be removed, and an open capsulectomy should be performed to remove all capsule scar tissue and calcified granulomas.
MENTOR® Corporation is now a subsidiary of Johnson & Johnson. Silicone Gel Implants. Warnings per MENTOR® for preventing unintentional loss of integrity of their silicone shell includes avoiding implant damage during surgery and medical treatment or procedures. According to MENTOR®, inadvertently physician or surgeon may contribute to premature implant failure. They explicitly state not allowing shelf instruments, scalpels or needles to contact the device, which seems common sense. The technique for inserting a gel implant is significantly different than for saline. Excessive force may be associated with a rupture inadvertently of the silicone implant weakening the shell. Avoid specific pushing the device into place with only one finger which may lead to a thinning out or weakness of the shell. They believe the incision has to be an appropriate length to accommodate the size and profile of the implant. The incisions are longer with silicone than saline implants to allow the placement of a pre-filled implant.
For augmentation, the mean incision size in centimeters for periareolar is 2.7 cm, inframammary 3.2 cm and axillary 3.4 cm with a mastectomy scar 4.0 cm. Teardrop implants or anatomic implants may be more difficult to insert and position correctly. Also, it is vital to avoid creating wrinkles or folds in the device during implantation, especially with revision surgery. Do not treat capsular contracture with closed capsulotomy or external compression which could lead to a hematoma seroma or rupture of the implant.
Also, plastic surgeons must be careful in subsequent procedures performed, including capsulotomies, hematoma seroma aspiration, biopsies or lumpectomies, to avoid the implant shell. Use of excessive force can undoubtedly cause weakening of the implant shell, leading to decreased performance. Silicone implants should not be placed through the periumbilical approach. Never put more than one implant in a pocket. Do not reuse or sterilize any product that was previously implanted. Do not alter the implants, attempt to repair or insert a damaged implant. Do not immerse implants in Betadine solution, and never allow contact of the implant with cautery devices which could lead to small tears in the shell. All silicone implants should have the integrity of the shell reviewed by the surgeon before placing the implant. This can be accomplished by a simple examination of the implant anterior and posterior surface, as well as by mild palpation of the implant, looking for any forms of exudation of silicone gel.
Rupture of the silicone gel implant may be silent. In other words, there may be no symptoms experienced by the patient and no signs or changes in the breast or implant itself. All patients should be advised per MENTOR® to have regular MRI’s over her lifetime screening for silent ruptures, even if she has not experienced noticeable complications. The first MRI should be performed at three years postoperative, then every two years afterward. Patients should seek MRI facilities that have at least a 1.5 Tesla magnet, a dedicated breast coil, and experienced radiologists examining breast implant MRI films for signs of rupture.