*From the Departments of Neurosurgery and Emergency Medicine (Dr. Levine), the University of Texas School of Medicine at Houston, Houston; Department of Pathology (Dr. Cartwright), Baylor College of Medicine, Houston; Department of Pathology (Dr. Cagle), the Methodist Hospital, Houston, TX; and Department of Pathology (Dr. Allen), the University of Texas Health Science Center at Tyler, Tyler, TX.
Correspondence to: Robert L. Levine, MD, Department of Neurosurgery, The University of Texas Health Science Center at Houston, 6431 Fannin St, Suite 7.142, Houston, TX 77030; e-mail: Robert.Levine@uth.tmc.edu
A woman with a history of bilateral mastectomy and silicone implants for fibrocystic disease and a history of atrial septal defect repair presented with pleural nodules on a chest radiograph. A thorascopic biopsy performed for possible mesothelioma demonstrated chronic inflammation and focal pleural fibrosis due to a foreign-body reaction secondary to silicone. This was confirmed using scanning electron microscopy and energy-dispersive radiograph elemental analysis. As the population ages, the increasing frequency of ruptured silicone implants and the need for heart surgery may result in a corresponding increase in the risk for fibrothorax secondary to inadvertent silicone introduction during surgery.
More than 1.5 million women in the United States have silicone breast implants.1 Due to safety concerns, in 1992 the US Food and Drug Administration restricted the use of silicone breast implants, and the Institute of Medicine issued a report1 on the safety of silicone breast implants, citing local and perioperative complications as the principal safety issues, noting that risks mount over the lifetime of an implant. Based on the Institute of Medicine conclusion that there was no support for a novel syndrome associated with silicone breast implants, nor increased risk for cancer, connective tissue diseases, neurologic diseases, or other systemic complaints,1 the Food and Drug Administration is considering reinstitution of silicone breast implants for augmentation mammoplasty.
The literature on existing silicone implants indicates as many as one third of symptomatic patients have ruptured gel implants at the time of explantation.2More than 465,000 women undergo chest surgery in the United States each year,3 with the potential for silicone from ruptured implants to be introduced into the pleural space at the time of surgery either through the surgery itself or chest tube placement. We present a case of fibrothorax due to introduction of silicone from ruptured implants at the time of atrial septal defect repair.
A 61-year-old woman presented for evaluation of a hard right inframammary mass. She noted the onset of the mass approximately 1 year earlier, 1 year after cardiac surgery for closure of an atrial septal defect. The patient complained of discomfort around the mass and a vague sense of discomfort in the right hemithorax with respiration. She had no systemic complaints. Her history was significant for deep venous thrombosis, nephrolithiasis, and a distant history of pneumonia. Significant surgical history included bilateral mastectomies for severe fibrocystic disease with submuscular silicone gel implants for breast reconstruction, and hysterectomy. She never smoked and had no known exposure to asbestos. Physical examination demonstrated a hard, 3-cm mobile mass over the tenth rib in the midclavicular line, but was otherwise unremarkable. A chest radiograph revealed right pleural based masses, confirmed on chest CT. These were suspicious for mesothelioma or metastatic disease, and the patient underwent thorascopic biopsy.
Routine glass-mounted histologic sections stained with hematoxylin-eosin were examined and photographed by light microscopy. They were reprocessed for scanning electron microscopy (EM) and energy-dispersive radiograph elemental analysis (EDXEA) by the method of Pickett et al.4 The tissue sections were transferred to graphite specimen mounts, coated with carbon, and examined in an electron microscope (100-C TEMSCAN; JEOL USA; Peabody, MA). Areas of interest studied by light microscopy were located and analyzed using a Tracor TN 5500 microprobe (Tracor-Northern; Madison, WI).
By light microscopy, hematoxylin-eosin–stained sections of the formalin-fixed, paraffin-embedded tissue showed lung parenchyma and overlying pleura, fibrous adhesions, and fibroadipose tissue. Within the pleura and fibroadipose tissue were numerous vacuoles of various sizes, occasionally surrounded by foreign-body giant cells. Translucent, refractile material was observed in many of the vacuoles (Fig 1
By EM, the refractile material within the vacuoles appeared fluid and noncrystalline (Fig 2
, top). EDXEA of the material in the vacuoles showed the mineral content to be exclusively silicon (Fig 3
). Dot mapping indicated that silicon distribution corresponded to the material seen in the light vacuoles by light microscopy (Fig 2, bottom).
Subsequently, the patient had both gel implants removed with free rupture of silicone noted at the time of surgery. The submammary mass was removed and found to be due to extruded silicone. The pleural masses have remained stable, although the patient notes pleuritic discomfort with painful respiration. Pulmonary function remains normal as documented by serial pulmonary function testing.
The frequency of rupture of gel implants is unknown. Brown et al5found that 77% of women with silicone breast implants, without regard to complaints or symptoms, had at least one breast implant rupture; median implant age at the time of rupture was 10.8 years. Extruded silicone causes localized and distant areas of inflammation in the breast and surrounding tissues, including axillary lymph nodes, leading to the formation of pseudotumors.6–7 Diagnosis of ruptured implants is difficult and is performed with physical examination, mammography, ultrasound, CT, and MRI. None of these techniques can detect all ruptures; CT and MRI detect approximately 80% and 90%, respectively.8–9 Proof that a lesion is due to silicone requires further testing. We used a combination of EM and EDXEA to prove that silicon was contained in the pleural nodules. EDXEA has been used infrequently in medicine to determine elemental content of foreign material within tissue.
To our knowledge, this is the first reported case of fibrothorax due to the introduction of silicone from ruptured breast implants at the time of cardiac surgery. Though this patient’s pulmonary function remains intact, fibrothorax can cause disabling dyspnea, and a severe restrictive defect or trapped lung, and may possibly require pleural decortication. We suspect the introduction of silicone into the pleural space in this case was associated with chest tube placement related to cardiac surgery. One case of pleural effusion was reported with a similar etiology,10and an acute empyema and pleural rind has been reported after chest tube insertion through an intact gel implant.11
With > 1.5 million women undergoing augmentation mammoplasties and > 465,000 chest surgeries performed annually,3 the likelihood is great that this complication will develop with increasing frequency as the population of women with implants ages and subsequently undergoes cardiac surgery. While the long-term risk for progression of the disease in this patient is unclear, the implication for the general population is that extreme care must be taken at the time of thoracic surgery or chest tube insertion to avoid introducing silicone into the pleural space when operating on women with silicone gel implants. If silicone breast implants are reintroduced into the market for general augmentation, the risk of silicone thorax will be extended for decades.
Abbreviations: EDXEA = energy dispersive X-ray elemental analysis; EM = scanning electron microscopy
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