Symptoms of Ruptured Silicone Breast Implants
[Silicone rupter] Patients present to my office weekly with ruptured silicone implants. They normally present with similar symptoms. Symptoms can include pain, swelling, redness or even tingling of the breasts. It can also be associated with scar tissue formation and pain associated with hardening of the capsule around the breast associated with a Baker IV capsular contracture. On the other hand, some patients may be asymptomatic and the results may be found on simply diagnostic radiograph, including MRI. Patients often will develop silicone mastitis and calcified granulomas due to ruptured silicone implant material once it becomes extracapsular. Intro versus extracapsular rupture must be identifiable. This can be determined on diagnosis with an MRI. Possible complications of retaining a ruptured silicone implant include intra extending to extracapsular rupture with subsequent lymphatic spread to the axillary lymph nodes and all lymphatic tissue throughout the body. No scientific evidence has been found linking ruptured silicone implants however with any serious diseases, including breast cancer or any autoimmune disease or connective tissue disorders. Patients who present with a loss of upper pole fullness of one breast, pain in the breast, increased swelling or redness to the breast should present for consultation to their Board Certified Plastic and Reconstructive Surgeon for evaluation, as well as diagnostic testing with an MRI in order to determine integrity of the shell of the silicone implant. 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; pathological reports should be determined from the pathologist, ruling out any possibility of breast cancer.
Diagnosis of Implant Rupture
Imaging in breast implant rupture has occurred since 1962. Silicone gel breast implants were first marketed in the United States of America that year. The FDA began regulating these medical devices in 1976. In 1992, the FDA, however, restricted the use of silicone gel implants to specific circumstances, except for those patients requiring revision or mastectomy surgery. At that time, saline implants became the workhorse, replacing silicone implants in 1992 to 2006. The imaging tests that can be used to determine a ruptured silicone gel breast implant include mammogram, CT scan, ultrasound and MRI. It has been found that the incidence of implant rupture will increase over time and that the silicone gel implants are not lifetime devices. Patients should undergo annual mammograms after the age of 35. When implant ruptures have been detected by mammogram they may not require further imaging studies and simply surgical intervention. However, mammography has been shown to have false/negative readings. In other words, negative mammograms for ruptured silicone have been found that the patient still may have ruptured silicone implant. Due to the limitations of mammogram and ultrasound, in November 2006, the FDA desires that patients every three years have an MRI performed, in order to determine the integrity of the shell of the silicone implant. CT scans may show some findings similar to that obtained with MRI, but it does involve ionized radiation and it has not been studied to the extent that the MRI’s have. Mammograms again are expensive, but the findings may be incorrect. The incidence of silicone breast implant rupture has been found to be approximately 15% rupture rate between the third and 10th year after implantation. Findings showed an overall rupture rate of approximately 5.3 ruptures per 100 implants per year. The rate of ruptures certainly has been shown to significantly increase with increasing implant age. 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, 835 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.
When a silicone breast implant ruptures, it usually does not deflate and it may be silent. The filler gel does leak from the implant over time and it can migrate through the implant pocket, become intracapsular and then extracapsular, which can then migrate throughout the chest tissue and throughout lymphatic tissue throughout the body.
Mechanisms of ruptured implants include damage during the original implantation of the implant, damage during other surgical procedures, blunt trauma, penetrating or blast trauma to the chest, chemical degradation of the breast implant shell, mechanical pressure of the breast, including mammograms and ultrasounds.
Rupture Rates for Silicone Gel Implants
[Implnats next to each other]
Allergan Pharmaceuticals. In Allergan’s core study, rupture was assessed for patients who had MRI screening for silent ruptures, as well as those who were not assessed 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 total cohort in the core study including 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 that rupture and the implant was replaced. The average age of implants was approximately 11 years. Silent rupture was found in approximately 15% of the combined group and 8% of revision patients. Studies of Danish women who were evaluated using MRI, found over a two-year period that 10% of the implants with intracapsular rupture progressed to extracapsular rupture by MRI. Approximately three-fourths of the implant ruptures remained intracapsular, with the remaining 25% extracapsular.
A summary by Natrelle Allergan Pharmaceuticals relating to health consequences of implant rupture has not been completely established. However, some of the local breast complications reported in the breast in the published literature were associated with increasing hardness to the breast associated with capsular contracture, change in breast shape and size, and breast pain. There have also been incidents of rare reports of gel movement to nearby tissue such as chest wall, armpit or abdominal wall or more distant locations down the arm even to the inguinal groin area. This had led to nerve damage, granuloma formation, and breakdown of tissue. There have been incidents of silicone presence in the liver of patients with silicone breast implants. It is a well known fact that silicone gel material will move to the lymph nodes in the axilla, even in women without evidence of rupture leading to lymphadenopathy. Concerns have been raised over ruptured implants associated with the development of connective tissue disease or symptoms such as fibromyalgia. Studies do not support a significant association of breast implants with any typical diagnosis of rheumatic disease.
Capsular contracture is greatly increased by patients with ruptured silicone implants. It is one of the most common reasons for reoperation. Capsular contracture is increased with infection, hematoma, and seroma, and the chance of occurrence increases over time.
Stages of capsular contracture include: Baker I, soft breast, no evidence; Baker II, palpable hardness to the breast; Baker III, palpable and visible distortion; and Baker IV, hard, palpable, visible and painful to the touch. Capsular contracture may be associated with increased incidents of actual rupture to the implant. The surgery will range from an open capsulectomy which is removing scar tissue, to a capsulotomy which is releasing the scar tissue around the bag. Patients presenting with ruptured silicone implants and capsular contracture will often be associated with increased pain of various intensities and may persist following the implant surgery. There may be changes in the nipple sensitivity. You can have either an increase or decrease in sensitivity, radiation therapy will greatly reduce sensitivity to the breast and chest wall. Infection or acute infection may even occur with a ruptured silicone implant. The signs of acute infection can include redness, swelling, tenderness, fluid collection, pain and fever and rarely toxic shock syndrome which can be potentially fatal. It is often associated with high fevers over 102 degrees, nausea, vomiting, a red rash, lightheaded, dizziness and hypotension. Patients should be immediately seen in the emergency room and treated accordingly if they have any signs or symptoms of toxic shock syndrome.
Mentor Corporation is now a subsidiary of Johnson & Johnson. Silicone Gel Implants. Warnings per Mentor with respect to 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 a premature implant failure. They specifically 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 in that area. They believe the incision has to be an appropriate length to accommodate the size and profile of the implant. It is obvious that the incisions are longer with silicone than saline implants in order 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. It has been found that the teardrop implants or anatomic implants may make it more difficult by insertion of the implant and repositioning it in the correct position. Also, it is vital to avoid creating wrinkles or folds in the device during implantation, especially with revision surgery. So much replacement of devices makes inspection for wrinkles significantly more difficult. Do not treat capsular contracture at any time by a 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 certainly cause weakening of the implant shell, leading to decreased performance. Silicone implants should not be placed through the periumbilical approach. Never place 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 prior to 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 within 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 absolutely no problems. The first MRI should be performed at three years postoperative, then every two years afterwards. 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.
Rupture Information on Mentor Implants. In Mentor’s core study, the rupture assessed for patients who had MRI’s to screen for silent ruptures were assessed. All reported ruptures were from patients in the MRI cohort. The rates were .5% for primary augmentation and 7.7% for revision augmentation.