Breast Implant Safety: A Complete Guide for Patients

The question about the safety of breast implants is one of the most frequently asked questions in the plastic surgery practice. In recent years, advances in materials and surgical techniques have significantly improved the safety profile of these devices. However, the decision to undergo augmentation mammoplasty requires an individualized medical assessment that takes into account each patient’s anatomy, realistic expectations and specific risk factors. At Mallorca Medical Group, Dr. Garcia Ceballos FCCP offers each patient a complete assessment before proposing any surgical plan related to Breast Augmentation.

What materials are modern breast implants made of?

Modern breast implants consist primarily of a silicone shell and an inner filling that may be cohesive silicone gel or saline solution. The latest-generation cohesive silicone gel implants —also known as highly cohesive gel or “gummy bear” implants— are currently the most widely used in Plastic Surgery in Mallorca and throughout Spain.

The outer casing can be:

• Smooth: completely uniform surface. Less friction with surrounding tissues.
• Textured (micro- or macro-textured): rough surface that promotes tissue adhesion and reduces implant displacement.
• Nanotextured: very fine texture that combines the advantages of smooth and textured surfaces with a well-studied safety profile.
• Polyurethane: shell with foam coating, which has the lowest documented rate of capsular contracture, although its use is more specific.

The choice of the type of surface is not arbitrary: it depends on the breast anatomy, the implant placement plane, the selected volume and the surgeon’s technical preference, always based on clinical evidence.

Regulation and certification: what guarantees implant safety

Breast implants marketed in Europe must undergo a rigorous evaluation process before obtaining the CE mark (European Conformity). This process includes biocompatibility testing, mechanical resistance testing, and long-term clinical follow-up. Since 2022, the European Medical Device Regulation (MDR 2017/745) has significantly tightened the certification and post-market surveillance requirements for breast implants, raising control standards for both manufacturers and surgical centers.

In Spain, the Spanish Agency of Medicines and Health Products (AEMPS) supervises the commercialization of these devices and keeps an updated registry of the authorized models. Trusted Plastic Surgery Clinics in Spain, such as Mallorca Medical Group, only work with implants from manufacturers that meet these regulatory standards.

Known complications: incidence and risk factors

Like any implantable medical device, breast implants carry risks that should be understood before surgery. The most studied complications are:

• Capsular contracture: formation of a hard fibrous capsule around the implant. It is the most common long-term complication. Its incidence varies according to the type of implant, the surgical technique, and individual patient factors.
• Implant rupture or deflation: uncommon with current cohesive gel implants, which maintain their shape even if the shell breaks.
• Displacement or malposition: may occur in the immediate postoperative period or long term, and is generally related to the surgical technique or the patient’s anatomy.
• Anaplastic large cell lymphoma associated to implant (BIA-ALCL): very rare pathology, mainly associated to implants with macrotextured surface of high roughness. Its estimated global incidence is 1 case per 30,000-500,000 patients with implants, depending on the model.

A thorough preoperative assessment and meticulous surgical technique are the main factors that contribute to minimizing the risk of complications.

Placement planes and their relationship to safety

The implant placement plane is one of the technical decisions with the greatest impact on long-term results and safety. The available planes are:

• Subglandular (prepectoral): the implant is placed between the mammary gland and the pectoralis major muscle. It offers natural results in patients with sufficient breast tissue.
• Submuscular (retropectoral): the implant is placed beneath the pectoral muscle. It reduces the incidence of capsular contracture and facilitates follow-up mammograms.
• Dual plane: a mixed plane that combines the advantages of both. It is the technique most frequently used by plastic surgeons with specialized training in Aesthetic Surgery in Mallorca and Europe.

The choice of plane should not be standardized: each patient requires an individualized assessment that takes into account the degree of breast ptosis, the thickness of the subcutaneous tissue, the thoracic projection and the desired volume.

“Safety in breast surgery does not only depend on the implant chosen, but also on the exhaustive preoperative evaluation, the precise surgical technique and the rigorous postoperative follow-up. Each surgical plan at Mallorca Medical Group is designed in a personalized way, with the objective of obtaining the best possible result for each patient.”

Dr. García Ceballos FCCP – Plastic, Aesthetic and Reconstructive Surgeon – Mallorca Medical Group

Postoperative follow-up: recommended protocol

Long-term follow-up is an essential component of safety in breast implant surgery. The leading international scientific societies, including ISAPS and SECPRE, recommend a structured monitoring protocol:

• Postoperative review at 7, 30, and 90 days after surgery.
• Annual or biannual long-term follow-up.
• Periodic breast ultrasound to assess implant integrity.
• Magnetic resonance imaging (MRI) 3 years after surgery and every 2 years thereafter, according to FDA recommendations and European guidelines.
• Mammograms according to the population screening schedule, adapting the technique to the presence of implants.

At Mallorca Medical Group, postoperative follow-up is an integral part of the surgical process and does not represent an additional service: it is part of the clinical responsibility of the medical team towards each patient.

Criteria for individualized implant selection

Choosing the most suitable implant for each patient is the result of an assessment that integrates multiple factors:

• Thoracic and breast anatomy: chest base, intermammary distance, degree of ptosis, skin quality and thickness.
• Lifestyle and physical activity: especially relevant in athletes or patients with high-intensity physical activity.
• Aesthetic expectations: natural result, moderate volume, or greater projection, always within anatomically coherent parameters.
• Medical history: history of previous breast surgery, oncological treatments, autoimmune diseases, or other relevant conditions.
• Digital planning or simulation: support tools that facilitate communication between the surgeon and the patient about the expected result.

The cost of plastic surgery in Mallorca for breast augmentation varies depending on the type of implant selected, the complexity of the procedure, the plane of placement and other clinical factors. The individualized estimate is prepared after a personalized medical evaluation.

Conclusion

The safety of modern breast implants is a fact supported by decades of clinical research, strict regulation, and post-market surveillance. However, the real safety of a Breast Augmentation procedure does not depend exclusively on the implant: it is determined by the appropriateness of the indication, the quality of the surgical technique, and the quality of postoperative follow-up.

At Mallorca Medical Group, Dr. Garcia Ceballos FCCP, with more than 34 years of clinical practice and specialized training at UZ VUB Brussels, develops for each patient a personalized surgical plan that takes into account all these factors. The goal is not only a satisfactory aesthetic result, but a safe, natural and lasting result.

Request your personalized assessment at Mallorca Medical Group and obtain all the information you need to make an informed decision about your health and aesthetic well-being.

Book your assessment at mallorcamedicalgroup.com

Frequently Asked Questions about Breast Implant Safety

Are modern breast implants safe?

The latest-generation breast implants have passed rigorous biocompatibility testing and hold CE certification and FDA approval. The materials used —primarily cohesive silicone gel— have a well-documented safety profile in thousands of clinical studies. However, like any surgical procedure, they involve risks that must be assessed on an individual basis with the plastic surgeon.

How long do breast implants last?

Modern implants do not have a set expiration date. However, medical guidelines recommend periodic follow-up every 1-2 years, including ultrasound or magnetic resonance imaging, to detect possible changes in the capsule or implant integrity. Most implants do not require replacement if no pathology is present, although the decision depends on each clinical case.

What is capsular contracture and how is it prevented?

Capsular contracture is the most common complication in breast implant surgery: it consists of the progressive hardening of the fibrous capsule that the body naturally forms around the implant. Factors influencing its occurrence include the implant placement plane, the type of surface, and the surgical technique. Appropriate implant selection and a careful surgical protocol help reduce its incidence.

What check-ups are recommended after breast augmentation with implants?

Postoperative follow-up includes reviews at 7, 30, and 90 days after the procedure, and annual or biannual long-term check-ups. Periodic breast ultrasound is recommended and, according to European guidelines, magnetic resonance imaging 3 years after surgery and every 2 years thereafter. This protocol allows early detection of possible complications and ensures implant integrity.

Article written by Dr. García Ceballos FCCP, Plastic, Aesthetic and Reconstructive Surgeon. Member of the SECPRE and the Collegium Chirurgicum Plasticum of Belgium. Mallorca Medical Group, Palma de Mallorca.

SOURCES: ISAPS Guidelines on Breast Implant Safety; SECPRE – Spanish Society of Plastic, Reconstructive and Aesthetic Surgery; European Regulation MDR 2017/745; FDA Breast Implant Safety Communications 2020; AEMPS – Spanish Agency of Medicines and Health Products.